A Study to Evaluate the Safety and Effectiveness of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation

Overview

  • Study type

    Interventional
  • Study phase

    III
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 18-009629
    NCT ID: NCT03683030
    Sponsor Protocol Number: BWI_2017_04

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • Diagnosed with Symptomatic Paroxysmal Atrial Fibrillation.
  • At least two symptomatic AF episodes within last six months from enrollment.
  • At least one ectrocardiographically documented AF episode within twelve (12) months prior to enrollment. 
  • Failed at least one Class I or Class III antiarrhythmic drug. 
  • Age 18 -75 years old.

Exclusion Criteria:

  • AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause. 
  • Previous surgical or catheter ablation for AF.
  • Previously diagnosed with persistent or long-standing persistent AF and/or Continuous AF > 7 days.
  • Any percutaneous coronary intervention within the past 2 months. 
  • Valve repair or replacement or presence of a prosthetic valve. 
  • Any carotid stenting or endarterectomy within the past 6 months. 
  • Coronary artery bypass grafting, cardiac surgery, or valvular cardiac surgical procedure within the past 6 months. 
  • Documented left atrium (LA) thrombus within 1 day prior to the index procedure. 
  • LA antero posterior diameter > 50 mm. 
  • Left Ventricular Ejection Fraction (LVEF) < 40%. 
  • Contraindication to anticoagulation (e.g., heparin).
  • Myocardial infarction within the past 2 months.
  • Documented thromboembolic event (including transient ischemic attack) within the past 12 months. 
  • Uncontrolled heart failure or New York Heart Association (NYHA) function class III or IV. 
  • Awaiting cardiac transplantation or other cardiac surgery within the next 12 months. 
  • Presence of implanted pacemaker or implantable cardioverter defibrillator (ICD).
  • Women who are pregnant, lactating, or who are of child bearing age and plan on becoming pregnant during the course of the clinical investigation.
  • Life expectancy or other disease processes likely to limit survival to less than 12 months.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Douglas Packer, M.D.

Open for enrollment

Contact information:

Laura Peterson

(507)255-7456

Peterson.Laura@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20459858

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