Clinical Trials

The purpose of this research is to gather information on the safety and effectiveness of proton radiation therapy in reducing the number of VT episodes in people like you who continue to experience VT despite treatment with an ICD and undergoing a previous catheter ablation.

The purpose of this study is to examine the fidelity of the electrical signal produced from non-adhesive textile electrodes in a chestband based form factor, to compare signals obtained between the chestband based form factor and the clinical 12 lead ECG recording done on the same day, and to assess the performance of an atrial fibrillation detection algorithm on the signals obtained pre-cardioversion (in atrial fibrillation) and post-cardioversion (in sinus rhythm) from the novel smart-clothing form factor and the routine 12-lead ECG.

This study is being done to understand whether the fluid that is normally in the pericardial space (2-3 ounces) that surrounds the heart contributes to  arrhythmias.

The primary objectives of the study are as follows:

• To describe the characteristics of patients receiving treatment for atrial arrhythmias with the IV formulation of sotalol;
• To describe the short-term safety and efficacy outcomes among patients receiving IV sotalol for atrial arrhythmias in clinical practice;
• To describe the pharmacokinetics (PK) and pharmacodynamics (PD) associated with IV sotalol loading;
• To assess feasibility of mobile ECG technology for monitoring among patients undergoing antiarrhythmic drug treatment.

The primary objective of this study is to demonstrate the superiority of at least 1 dose of intranasal MSP-2017 over placebo in terminating paroxysmal supraventricular tachycardia induced in an electrophysiology laboratory

The objective of this study is to investigate this phenomenon by identifying such patients and analyze this relationship using biomarkers (blood and urine signal proteins) related to volume control such as pro-atrial natriuretic peptide (pro-ANP), N-terminal B-type natriuretic peptide (NT-proBNP), cyclic-GMP (a downstream second messenger for natriuretic peptides) and copeptin (the pre-pro-hormone of antidiuretic hormone).

The purpose of this study is to determine the feasibility, safety and diagnostic yield of a modified treadmill exercise stress testing with a running protocol in the detection of exercise-induced arrhythmias.

The purpose of this study is to assess termination of atrial fibrillation (AF) following delivery of cold treatment to the oblique sinus using an experimental cooling module.

The aim of the present study is to assess the use of high-resolution imaging data from CT and or MRI processed in 3D meshes with the use of the MUSIC software (inHEART, Bordeuax, France) and integrated within the EP lab environment to assist catheter ablation procedures. The MUSIC software is a proprietary software developed by cardiac electrophysiology and radiology researchers at the University of Bordeuax, France, that allows high-resolution recostruction of CT and MRI cardiac imaging for integration into electroanatomic maps in ablation procedures2,3.

The purpose of this study is to learn about patients' values and perceptions of content that should be included in initial atrial fibrillation education, identify their recommendations for approaches to education, and teach them features of healthcare provider communication that make it possible for patients to better manage their atrial fibrillation and self-care activities. Additionally the study aims to learn about healthcare providers' perceptions of content they believe to be important, and identify approaches to education that can be used in their practice.

The primary objective of this clinical investigation is to demonstrate safety and effectiveness of the Multi-Electrode RF Balloon catheter for the treatment of drug refractory symptomatic paroxysmal atrial fibrillation.

The purpose of this study is to demonstrate the safety and effectiveness of the CardioFocus Endoscopic Ablation System with Adaptive Contact (HeartLight) in the treatment of atrial fibrillation by creating electrical isolation of the pulmonary veins.

The purpose of this study is to evaluate the outcomes of a community placed atrial fibrillation (AF) screening and education program

The purpose of this study is to determine arterial stiffness in patients with atrial fibrillation (AF) using acoustic radiation vibrometry, to compare acoustic radiation force (ARF) measurements in patients with AF before and after electrical cardioversion, and to determine whether arterial stiffness predicts recurrence of AF after cardioversion.

The purpose of this study is to evaluate the number of leaks from the LA into the LAA, and the size of each. 

Colchicine will lower C-reactive protein (CRP) in chronic atrial fibrillation and reduce the rise in CRP which occurs following atrial fibrillation ablation

The purpose of this study is to provide safety and effectiveness data regarding the use of the Adagio System in the treatment of Persistent Atrial Fibrillation (PsAF).

The purpose of this study is to demonstrate the safety and effectiveness of ventricular ablation therapy using the FlexAbility Sensor Enabled Ablation Catheter in patients with drug-refractory monomorphic ventricular tachycardia in whom ventricular tachycardia recurs despite antiarrhythmic drug therapy or when antiarrhythmic drugs are not tolerated or desired.

The objective of this trial is to evaluate the effectiveness of left atrial appendage exclusion (LAAE) for the prevention of ischemic stroke or systemic arterial embolism in subjects undergoing cardiac surgery who have risk factors for atrial fibrillation and ischemic stroke.

The purpose of this study is to obtain electro-anatomic maps of human myocardium in sinus rhythm and ventricular arrhythmias to identify activation patterns, identify and perform tissue ablation at targeted sites of interest that could play an important trigger for development of arrhythmias, and to perform histologic analysis of the myocardial tissue to identify triggers and/or targets for therapies to terminate ventricular arrhythmias.

The purpose of this study is to determine if an AF detection intervention in men and women at least 70 years of age with undiagnosed atrial fibrillation (AF) or atrial flutter (AFL) reduces the person-years incidence rate of stroke compared to usual care (no AF detection intervention).

The study is a prospective, non-randomized, multi-center investigation to establish the safety and effectiveness of the WATCHMAN FLX™ Left Atrial Appendage Closure Device for subjects with non-valvular atrial fibrillation who are eligible for long-term anti-coagulation therapy to reduce the risk of stroke but who have a rationale to seek a non-pharmacologic alternative.

This is a prospective, multicenter, non-randomized clinical evaluation utilizing the THERMOCOOL SMARTTOUCH® SF catheter compared to a predetermined performance goal.

The purpose of this study is to evaluate stellate ganglion blockade with local anesthetic intraoperatively to reduce the development of postoperative atrial fibrillation.

Atrial fibrillation is an important postoperative complication following cardiac surgery despite many attempts to reduce the incidence. Temporary stellate ganglion blockade reduces ventricular arrythmias in various circumstances with animal and early human data also showing an effect on the development of atrial fibrillation. The duration of arrythmia control outlasts the expected duration of local anesthetic effect by a significant duration.  Stellate ganglion blockade has potential for great impact reducing the burden of POAF including large cost savings, reduction in ...

The purpose of this study is to assess the immediate effect of cardioversion on both the tricuspid and mitral annular dynamics and size in patients with atrial fibrillation, and to compare the annular dynamics and dimensions in both the tricuspid and mitral valves immediately before and after cardioversion in patients with atrial fibrillation using 3D transesophageal echocardiography.

The purpose of this study is:

1. To assess whether corrective rhythm procedure during robotic mitral valve repair produce reliable long-term results.
2. To determine the incidence of new onset atrial fibrillation after robotic mitral valve repair.
3. To determine whether rhythm plays a role in long term valvular function.
4. As a secondary aim, we would like to study the outcomes of small subset of patients (10 patients) who underwent robotically assisted left atrial mass removal.
5. As a secondary aim, we also plan to look at our robotic patients and compare them to the conventional repair cohort to study the various echocardiographic parameters.

The primary objective of this study is to determine if left atrial appendage closure with the WATCHMAN FLX device is a reasonable alternative to non-vitamin K oral anticoagulants (NOACs) in patients with non-valvular atrial fibrillation.

The purpose of the study is to provide data demonstrating the safety and effectiveness of the PulseSelectTM PFA System for the treatment of paroxysmal and persistent atrial fibrillation.

The purpose of this study is to compare the Sentinel® Cerebral Protection System to the standard of care (no cerebral protection) in patients undergoing atrial fibrillation (AF) catheter ablation.

The primary objective of this study is to determine if left atrial appendage closure with the WATCHMAN FLX Device is a reasonable alternative to oral anticoagulation following percutaneous catheter ablation for high risk patients with non-valvular atrial fibrillation.

This is a prospective randomized comparative evaluation of Edoxaban and Warfarin for safety and efficacy in perioperative use in patients with non-valvular atrial fibrillation (AF) undergoing clinically indicated implantation or replacement of cardiovascular implantable electrical devices.The primary objective is to compare the rates of local and systemic bleeding in subjects randomized to Edoxaban compared to subjects randomized to continuous warfarin in within 30 days of cardiac rhythm device implant with concomitant non-valvular AF.

The purpose of this study is to determine and compare the safety and efficacy of transcutaneous afferent patterned stimulation (TAPS) and respiratory-gated auricular vagal afferent nerve stimulation (RAVANS) therapies for the reduction of paroxysmal atrial fibrillation (AF) burden.

The purpose of this study is to evaluate the safety and effectiveness of AtriCure's CryoICE Ablation System in performing the Cox-Maze III Lesion set surgical procedure, in conjunction with LAA exclusion using ArtiCure's AtriClip device.

The effectiveness of the device will be demonstrated by establishing that the device effectively eliminates persistent and long-standing persistent atrial fibrillation in a clinically significant proportion of treated patients.

The purpose of this study is to help researchers better understand the impact of wearable devices on patient experience and clinical trends following a cardioversion.

The purpose of this study is to assess the safety and performance of the Hansen Medical Sensei Robotic System and Artisan Catheter when used to robotically manipulate RF ablation catheters for the treatment of paroxysmal atrial fibrillation (irregular heartbeats originating in the upper chambers of the heart).

The purpose of this study is to describe the incidence and type of arrhythmia seen in patients with Eisenmenger syndrome, to define predisposing factors potentially leading to the onset of arrhythmia, and to describe the influence of arrhythmia on outcomes.

The purpose of this study is to assess the safety and function of the Aegis Sierra Ligation System in accessing and closing off the left atrial appendage (LAA) using a minimally invasive epicardial access approach.

A minimum of 30 participants will be included in this study, which is being performed at a maximum of 8 centers in Canada and the United States. (A maximum of 5 participants at 4 US centers will be enrolled)

Participants will be considered for this treatment if their doctor(s) have determined they have documented non-valvular atrial fibrillation and are at increased risk for ...

The purpose of this study is to develop an evidence-based decision aid for patients with nonvalvular chronic atrial fibrillation.

The purpose of this study is to determine if treatment with dronedarone on top of usual care is superior to usual care alone for the prevention of cardiovascular hospitalization or death from any cause in patients hospitalized with first-detected  atrial fibrillation (AF).

The primary objective of this study is to determine whether etripamil nasal spray (NS) 70 mg is superior to placebo at terminating episodes of PSVT in an outpatient setting.

The purpose of this study is to assess if deviating the esophagus will reduce/eliminate ablation injury to the esophagus.

The purpose of this study is to utilize neuECG, a new method to directly and non-invasively record skin sympathetic nerve activity (SKNA) and electrocardiogram (ECG), to non-invasively assess the effects radiofrequency catheter ablation (RFCA) on SKNA in patients at high risk for life-threatening ventricular arrhythmias (VA).

Patients with a patent foramen ovale in the setting of endocardially placed cardiac implantable electronic devices such as pacemakers, defibrillators, or resynchronization therapies are likely at higher risk for paradoxical embolic events from device lead thrombus. The investigators are conducting this study to determine if the anticoagulant medication Apixaban is more effective at reducing MRI detected brain lesions compared to placebo.

The purpose of this study is to explain the functional change mechanism linking right atrial (RA) hypertension, right heart (RH) remodeling and onset of symptoms such as arrhythmias and impaired aerobic capacity, since symptomatic status is a risk factor for mortality in the Tetralogy of Fallot (TOF) population.

1. The primary purpose of this study is to assess the comparative effectiveness of the following 4 approaches to promote high-quality SDM for at-risk patients with AF:  a PDA alone, (2) an EDA alone, (3) a combination of a PDA and an EDA, and (4) control with neither a PDA nor an EDA.

The purpose of this study is to demonstrate that scar-based ventricular tachycardia (VT) ablation using the FlexAbility™ ablation catheter system results in a superior clinical outcome compared to routine drug therapy in subjects with documented Monomorphic Ventricular Tachycardia [MMVT] (both ischemic and non-ischemic) while maintaining an acceptable safety profile.

The purpose of this study is to determine if an atrial fibillation (AF) detection intervention in men and women at least 70 years of age with undiagnosed AF or atrial flutter (AFL) reduces the person-years incidence rate of stroke compared to usual care (no AF detection intervention).

The purpose of this study is to determine if nonInvasive cardiac radioablation (NICRA) can provide selective access to deeper scarred myocardial tissue for ablation. 

The purpose of this study is to determine if MPI SPECT phase analysis can detect varying degrees of abnormal heart rhythm between patients with normal coronary artery circulation, ischemia (poor blood circulation), and infarct (area of dead tissue) from loss of circulation.

The purpose of this study is to assist patients and clinicians weigh the potential harms and benefits of different treatment options for atrial fibrillation.  The plan is to develop an evidence-based decision aid for use in clinical encounters. The goal is to promote evidence-based patient-centered care. Ideally, this care should reflect the research evidence about treatment options for atrial fibrillation. It should also reflect the values and preferences of the informed patient.

The primary objective of this study is to determine whether etripamil nasal spray (NS) 70 mg is superior to placebo at terminating episodes of Paroxysmal Supraventricular Tachycardia (PSVT) in an outpatient setting.

The purpose of this study is to collect and review the Mayo Clinic experience with left cardiac sympathetic denervation (LCSD) in patients with heritable arrhythmias syndromes or refractory ventricular arrhythmias beginning in 2000.

The purpose of this study is to investigate skin sympathetic nerve activity (SKNA) in correlation with cardiac arrhythmias and/or heart failure.

The purpose of this 12 week study is to assess the safety of oral IW-1973 when administered to patients with heart failure with preserved ejection fraction (HFpEF) and its effect on peak exercise capacity, both in all patients and in patients without permanent or persistent atrial fibrillation

The purpose of this study is to assess the decline in cognitive function using standardized neurocognitive assessment in Atrial Fibrilation patients treated with Apixaban vs Warfarin.

The purpose of this study is to measure the effect on ventricular ectopy, safety, tolerability and pharmacokinetics of S48168 (ARM210) compared with placebo in participants with Type 1 Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT1).

The purpose of this study is to characterize the impact of Atrial fibrillation (AFib) and Atrial Flutter (AFl) on signals measured using a wearable Insertable Cardiac Monitor (ICM) prototype device.

The objectives of this study are to measure psychosocial cardiac distress* in Latinx/Latino/Hispanic (L/H) women with a history of an acute coronary syndrome (ACS), as well as those with traditional cardiovascular risk factors, but no ACS (diabetes, hypercholesterolemia, obesity, and hypertension), to examine the effects a composite measure for psychosocial cardiac distress has on health-related quality of life (QoL) on women with ACS and those with cardiovascular risk factors and to examine the impact acculturation, acculturative stress, perceived discrimination, and familism can have on the association between cardiac distress and QoL on L/H women with ACS and cardiovascular risk factors. 

*Cardiac distress is defined as ...

The purpose of this study is to compare the rate of arrhythmia-induced events between paediatric Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT) patients with and without implantable cardioverter defibrillator (ICDs), and to determine the quality of life and psychosocial functioning of paediatric CPVT patients with and without ICDs.

The aims of this investigation are:

To assess the predictive value (and accuracy) of clinical and physiologic preoperative variables in identifying patients at risk for the development of new-onset atrial arrhythmia after cardiac surgery.

To assess the feasibility of a physiological risk model based on clinical and echocardiographic indexes to predict post-operative AF.

To assess the role of prophylactic agents in the prevention of new-onset postoperative POAF

To assess the economic impact of new-onset postoperative AF:

• Length of hospital stay (will be measured as fractions of days)

• Hospital cost (will be measured in standardized dollars)

• Resource utilization (will be measured by resource-based relative-value units)

To assess the outcome ...

The postnatal diagnosis of Long QT Syndrome (LQTS) is suggested by a prolonged QT interval on 12 lead electrocardiogram (ECG),a positive family history and/or characteristic arrhythmias and confirmed by genetic testing.  LQTS testing cannot be performed successfully before birth as   fetal ECG is not possible and direct measure of the fetal QT interval by magnetocardiography is limited. Genetic testing can be performed in utero, but there is risk to the pregnancy and the fetus. Although some fetuses present with arrhythmias easily recognized as LQTS (torsade des pointes (TdP) and/or 2° atrioventricular (AV) block, this is uncommon, occurring in <25% of fetal ...

The purpose of this study is to prospectively determine if direct current cardioversion (DCCV) results in myocardial injury as assessed by changes in high sensitivity cardiac troponin T (hs-cTnT) assay.

The purpose of this study is to examine if the measurements that we make by current standards for patients with both aortic stenosis (narrowed aortic valve) and atrial fibrillation underestimate severity of aortic stenosis and if that has any effect on timing of aortic valve surgery

The purpose of the MODULAR ATP Clinical Study is to demonstrate safety, performance, and effectiveness of the Modular Cardiac Rhythm Management (mCRM) Therapy System.

The purpose of this study is to determine if apixaban given for 6 months is safer than Vitamin K Antagonist (VKA) given for 6 months in terms of major bleeding and non-major bleeding in patients with an irregular heart beat (atrial fibrillation) and a recent heart attack or in atrial fibrillation patients undergoing a procedure to open up a blood vessel in the heart (percutaneous coronary intervention). All patients would also be taking a class of medicines called P2Y12 inhibitors (such as clopidogrel). All patients would be treated for an intended 6 months.

The purpose of this study is to characterize TRPC6 risk variants for doxorubicin-related cardiotoxicity in prospectively collected samples from breast cancer patients.   

Breast cancer patients are more than three times at risk for developing congestive heart failure (CHF), compared with patients who did not have cancer. The increased risk of HF is observed as early as one year from diagnosis of cancer and overall, 7% of patients develop CHF (median follow-up 8.5 years) 

The purpose of this study is to identify and characterize heart rhythm disorders including atrial arrhythmias such as atrial fibrillation, ventricular arrhythmias such as ventricular tachycardia, conduction abnormalities, etc. among patients with spontaneous coronary artery dissection (SCAD).

The purpose of this study is to evaluate the feasibility and safety of a management approach that incorporates VT-ablation and S-ICD implantation in secondary prevention patients. This is a single arm prospective study with 30 patients eligible for implantation of an ICD for the secondary prevention of sudden cardiac death.

The purpose of this study is to determine the incidence of atrial and ventricular arrhythmias in patients with hypertrophic cardiomyopathy, with and without sleep apnea.

The primary purpose of this study is to determine if apixaban is superior to aspirin for prevention of the composite outcome of any stroke (hemorrhagic or ischemic) or death from any cause in patients with recent ICH and atrial fibrillation (AF).

The purpose of this study is to verify that high Premature Ventricular Complex (PVC) burden is associated with increased risk of stroke and/or Transient Ischemic Attack (TIA), to examine outcomes such as stroke/TIA, atrial fibrillation/flutter, and all-cause mortality associated with PVCs, and to evaluate whether PVCs are associated with development of appendage dysfunction.

The purpose of this study is to learn about the effect of atrial fibrillation on memory and thinking. This study helps us to determine how often memory problems occur in patients with atrial fibrillation and identify factors that influence changes in memory and thinking.