Clinical Trials

The purpose of this study is to examine characteristic (electrophysiological) of ventricular arrhythmias, ablation technique and outcomes in patients with prosthetic valve.

This proposal is aiming at modifying and improving persistent AF management guidelines by evaluating targeting DE-MRI detected atrial fibrosis during AF ablation and its related effect on procedural outcome.

OBJECTIVES:

Primary Objective: To examine the efficacy of targeting atrial fibrosis tissue during an ablation procedure in treating persistent AF. Results from the DECAAF study show that one of the most important predictors of ablation outcome was the degree of ablation of the fibrotic tissue; the more fibrotic tissue that was overlapped with scar during ablation, the better the outcome. These results were the impetus for the primary outcome ...

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 determine long term vital status, symptoms, and need for repeat procedure after alcohol septal ablation, to determine patient and procedural factors associated with successful alcohol septal ablation and need for repeat procedure, and to determine the impact of conduction abnormalities after alcohol septal ablation on long-term outcomes.

The purpose of this study is to establish the safety and effectiveness of the Blazer Open-Irrigated radiofrequency ablation catheter for the treatment of drug refractory, recurrent, symptomatic, paroxysmal atrial fibrillation.

We want to determine the efficacy and safety, and the rate and type of side effects of this technique; as well as to delineate the clinical pathologic outcomes of the patients with thyroid cysts treated with Percutaneous ethanol injection (PEI) at Mayo Clinic, Rochester MN, since there is limited information of the use of this technique in the American literature.

The purpose of this study is to determine biomarkers which can predict response to ablation therapy in patients with Barretts esophagus.

The standard of care for obstructive hypertrophic cardiomyopathy (HCM) refractory to medical therapy is surgical septal myectomy. Percutaneous transluminal septal myocardial ablation, otherwise known today as alcohol septal ablation (ASA) has been growing as a favorable alternative to myectomy. There have been no randomized controlled trials conducted to evaluate ASA versus surgical myectomy. The purpose of this study is to compare overall survival between surgical septal myectomy and alcohol septal ablation. The study will also compare periprocedural and long-term complication rates for both myectomy and alcohol septal ablation. Furthermore, the study willl determine the rates of re-intervention for both myectomy ...

Single-arm, interventional pivotal clinical trial collecting patient data from use of the AQUABEAM System, a personalized image-guided waterjet resection system that utilizes a high-velocity saline stream to resect and remove prostate tissue in males suffering from Lower Urinary Tract Symptoms (LUTS) due to Benign Prostatic Hyperplasia (BPH).The primary endpoints for safety and effectiveness will be measured at 3 months post-treatment. All treated subjects will be followed out to 12 months to collect long-term clinical data.

The purpose of this registry is to collect clinical safety and outcomes data on the use of the STAR™ Tumor Ablation System on patients with painful cancer matastases of their thoracic or lumbar spine.

This is a study of epidermal (the outer most layer) nerve fibers (ENFs) in the skin of the body; counts of which are used to determine a disease of nerves called "small nerve fiber neuropathy."

Capsaicin is approved by the Food and Drug Administration (FDA) for pain relief. Since 0.1% capsaicin is known to cause ablation (removal) of ENFs, this study will test whether such ablation results in relief of spontaneous pain, touch, or heat-pain.

The study is designed to evaluate the safety and efficacy of the Visualase MRI-guided laser ablation system for mesial temporal epilepsy (MTLE).

This is a pilot study to investigate the performance of MR-guided Laser Induced Thermal Therapy (LITT) in the treatment of liver tumors.

The purpose of this study is to see if MR-guided laser ablation can effectively treat prostate tumor recurrences.

The purpose of this study is to determine if MRI-guided laser ablation and cryoablation result in significant improvements in both pain severity and pain interference measures at intermediate-term follow-up in patients with painful, soft-tissue vascular anomalies. The study will also test the hypothesis that immediate loss of intrinsic vascular anomaly T2 signal is an imaging biomarker to predict decreased pain and VA volume following MRI-guided laser ablation and cryoablation in patients with painful, soft-tissue vascular anomalies. 

The purpose of this multicenter, prospective, single arm, non-randomized clinical trial to evaluate the safety and efficacy of the C2 CryoBalloon Focal Ablation System (CbFAS) for the treatment of persistent dysplasia or intestinal metaplasia (IM) in the tubular esophagus after 3 or more radiofrequency ablations (RFA) for dysplastic BE, or <50% eradication="" of="" barrett's="" esophagus="" (be)="" after="" 2="" rfa="">

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 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 characterize the use of the Monteris NeuroBlate System for the performance of brain laser interstitial thermal therapy (LITT) ablation treatment of medial temporal lobe epilepsy that is resistant to medical tharapy.

VICTORY AF is an IDE, prospective global, multi-center, single arm, controlled, unblinded, investigational clinical study. The purpose of this clinical study is to evaluate the risk of procedure and/or device related strokes in subjects with persistent or long-standing persistent atrial fibrillation (AF) undergoing ablation with the Phased RF System.

The primary objective is to determine the safety of the C2 CryoBalloon Full Ablation System (“CryoBalloon Full”) used at increasing doses in subjects with non-dysplastic, Low-Grade Dysplastic (LGD) or indefinite for dysplasia Barrett’s Epithelium (BE).              

A secondary objective is to evaluate CryoBalloon Full efficacy, evaluated by the percentage of regression of BE after ablation at a particular dose with the Full Ablation System.

The purpose of this study is to create a registry that follows patients for a total of 5 years from the date of the first liver ablation procedure with the NEUWAVE Microwave Ablation System.

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).

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.

The purpose of the study is to look at the safety and effectiveness of using BioTraceIO Lite software during an ultrasound for patients who are having a liver ablation procedure.

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 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.

Post market prospective, non-randomized, single-arm, multicenter study, designed to demonstrate dose response of an ablation system using a percutaneous approach in patients with primary, metastatic, or recurrent primary lung tumors.

This is a prospective, randomized, multicenter comparison study examining the outcomes of subjects with osteoarthritis and knee pain undergoing a procedure to create a radiofrequency lesion of the genicular nerves with the Cooled Radiofrequency Ablation (CRFA) system compared to subjects receiving Hyaluronic Acid (HA). Approximately 168 subjects will be enrolled into this study, with subjects undergoing either CRFA or HA injection in a 1:1 randomization scheme. Follow-up will be conducted for 12 months post-CRFA, with the primary endpoint being completed at month 6. Subjects randomized to the comparison (HA) group will have the option to cross-over to the neurotomy group ...

The goal of the study is to identify immune responses (immune cell activation and suppression) following local ablation of liver tumors.

The primary purpose of this study is to assess the accuracy of the Philips High Precision 3D Ablation Solution software on cross-sectional imaging evaluation of microwave-ablated liver tumors, and to determine whether software accuracy varies based on patient, tumor, and technical procedural factors.

The purpose of this study is to evaluate if lung ablation improves clinical outcomes for patients deemed to be surgically high-risk.

To investigate whether MR-guided laser induced thermal therapy in patients diagnosed with focal lesional epilepsy using the Visualase Thermal Therapy System is both a feasible and safe minimally invasive technique for control of seizures in such patients.

The purpose of this study is to evaluate the accuracy of the BioTrace IO during RFA/MWA Transcutaneous procedures.

The purpose of this study is to validate a core biopsy technique for obtaining tissue from treatment naive vascular anomalies for clinical pathology and genomic analyses in patients undergoing clinically indicated sclerotherapy, embolization and/or ablation.

This study aims to perform a prospective analysis of patients undergoing fibrillation ablations and compare the validity of the electroanatomical registration with superimposed angiography. In addition, this study aims to compare and understand the relationship between the cardiac vessels.

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 retrospectively analyze potential correlation between ablation zone/margin and tumor recurrence by using the Software Product to quantitatively evaluate diagnostic/pre-operative CT images, intra-operative CT images during ablation procedures, and follow-up CT images; and to apply and evaluate the FDA cleared Software Product during CT-guided ablation procedures for intra-operative monitoring and confirmation.

 

To evaluate the efficacy and safety of the CryoBalloon Focal Ablation System for the treatment of previously-untreated ("treatment naïve") Barrett's Esophagus (BE)

The purpose of this study is to evaluate the safety and effectiveness of the Vanquish Water Vapor Ablation Device ("Vanquish") in treating subjects with Gleason Grade Group 2 (GGG2) localized intermediate-risk prostate cancer.

The purpose of this study is to determine the safety of the NanoKnife treatment in prostate cancer tissue when used in a low and intermediate risk patient population.

The purpose of this study is to evaluate the efficiency of Radiofrequency ablation (RFA) therapy to treat papillary thyroid carcinoma.

The purpose of this study is to demonstrate that microwave ablation (MWA) of up to 3 hepatic metastases, each with a maximum diameter of ≤ 2.5 cm will result in a 2-year local progression free survival of at least 90%. This is a standard of care (SOC) study.

The purpose of this study is to evaluate the pathologic response of soft tissue ablated with Pulsed Electric Fields (PEF) in patients with non-small cell lung cancer (NSCLC) who may be candidates for resection following standard of care (SOC) neoadjuvant use of checkpoint inhibitor (nivolumab) treatment plus platinum doublet chemotherapy.  

The purpose of this study is to determine the safety of the NanoKnife treatment in prostate cancer tissue when used in a low and intermediate risk patient population.

To determine the efficacy of using MRI/US fusion imaging technology to direct focal ablation of prostate tissue using nanoparticle-directed laser irradiation.

The purpose of this study is to test the validity of durvalumab and VEGF inhibitor therapy to enhance anti-tumor immune responses to produce significant and consistent clinical benefit in patients with Hepatocellular Carcinoma (HCC) after curative hepatic resection or ablation.

The purpose of this study is to determine if Stereotactic Ablative Radiotherapy improves survival over sublobar resaction in high risk operable stage I non-small cell lung cancer.

This study will investigate if nivolumab will improve recurrence-free survival (RFS) compared to placebo in participants with HCC who have undergone complete resection or have achieved a complete response after local ablation, and who are at high risk of recurrence