Filter Results

Clinical Studies

Open

  • A Feasibility Study of Peripheral Nerve Stimulation Therapy for Atrial Fibrillation Rochester, Minn.

    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.
  • Collection of Single-Lead ECG Data Using Prototype MoMe ARC 1-Lead Patch for Analysis Using Current Multi-lead ECG Algorithms Rochester, Minn.

    The primary objective of this study is to collect data from a single-lead ECG patch device (MoMe ARC 1-Lead Patch) for evaluation using InfoBionic ECG automated algorithms (FDA 510(k) = K152491) to make any needed adjustments for use in single-lead ECG data that will be included in FDA 510(k) submission for MoMe ARC Modular System. Data collection will be completed in both outpatient and inpatient subjects undergoing clinically indicated cardiac rhythm monitoring for previously diagnosed cardiac rhythm abnormatlities or exploratory monitoring for evaluation of symptoms and risk factors.
  • Medtronic Product Surveillance Registry (PSR) Rochester, Minn.

    The purpose of the Registry is to provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products. The Registry data is intended to benefit and support interests of patients, hospitals, clinicians, regulatory bodies, payers, and industry by streamlining the clinical surveillance process and facilitating leading edge performance assessment via the least burdensome approach.
  • Strategies for Catheter Ablation of Persistent Atrial Fibrillation: A Randomized, Comparative Study – STAR AF 3 (STARAF3) Rochester, Minn.

    The purpoose of this study is to compare the efficacy of three different ablation strategies in patients with persistent AF: 1. PV antral isolation alone (PVAI) 2. PV antral isolation plus ablation of drivers (PVAI+drivers) 3. PV antral isolation plus isolation of posterior wall (PVAI+box) All three strategies will employ contemporary catheter ablation technology using more efficient open irrigated tip cooling and contact force sensing.

Closed for Enrollment

  • ECG Belt for CRT Response Rochester, Minn.

    The purpose of this study is to compare ECG Belt Research System managed cardiac resynchronization therapy (CRT) patients and a control CRT group with respect to left ventricular (LV) remodeling.
  • Prospective Evaluation Analysis and Kinetics of IV Sotalol (PEAKS Registry) Rochester, Minn.

    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.
  • Smart Clothing for the Detection of Cardiac Electrical Activity and Arrhythmias Rochester, Minn.

    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.
.