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

Overview

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.

Inclusion Criteria:

  • Diagnosed with Symptomatic PAF (Physician’s note indicating recurrent self-terminating AF):
    • At least two (2) symptomatic AF episodes within last six (6) months from enrollment.
    • At least one (1) electrocardiographically documented AF episode within twelve (12) months prior to enrollment. Electrocardiographic documentation may include, but is not limited to, ECG, Holter monitor, or telemetry strip.
  • Failed at least one (1) Class I or Class III AAD as evidenced by recurrent symptomatic AF, contraindication to the AAD, or intolerable side effects to the AAD.
  • Age 18 -75 years.
  • Able and willing to comply with all pre-, post- and follow-up testing and visit requirements.
  • Signed Patient Informed Consent Form.

Exclusion Criteria:

  • AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (e.g., documented obstructive sleep apnea and acute alcohol toxicity).
  • Previous surgical or catheter ablation for AF.
  • Patients known to require ablation outside the PV ostia and CTI region (e.g. atrioventricular reentrant tachycardia, atrioventricular nodal reentry tachycardia, atrial tachycardia, ventricular tachycardia, and Wolff-Parkinson-White).
  • Previously diagnosed with persistent or long-standing persistent AF and/or Continuous AF > 7 days.
  • Any percutaneous coronary intervention within the past 2 month.
  • 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 (e.g., ventriculotomy, atriotomy), 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).
  • History of blood clotting or bleeding abnormalities.
  • Myocardial infarction within the past 2 months.
  • Documented thromboembolic event (including transient ischemic attack) within the past 12 months.
  • Rheumatic Heart Disease.
  • 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.
  • Unstable angina.
  • Acute illness or active systemic infection or sepsis.
  • Diagnosed atrial myxoma or presence of an interatrial baffle or patch.
  • Presence of implanted pacemaker or implantable cardioverter defibrillator (ICD).
  • Significant pulmonary disease, (e.g., restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms.
  • Significant congenital anomaly or medical problem that, in the opinion of the investigator, would preclude enrollment in this study.
  • Women who are pregnant (as evidenced by pregnancy test if pre-menopausal), lactating, or who are of child bearing age and plan on becoming pregnant during the course of the clinical investigation.
  • Enrolled in an investigational study evaluating another device, biologic, or drug.
  • Has known pulmonary vein stenosis.
  • Presence of intramural thrombus, tumor or other abnormality that precludes vascular access, or manipulation of the catheter.
  • Presence of an inferior vena cava filter.
  • Presence of a condition that precludes vascular access.
  • Life expectancy or other disease processes likely to limit survival to less than 12 months.
  • Presenting contra-indication for the devices (e.g., TTE, Holter, CT, etc.) used in the study, as indicated in the respective instructions for use.

Additional Exclusion Criteria for NAE Subjects:

  • Contraindication to use of contrast agents for MRI such as advanced renal disease, etc. (at PI discretion).
  • Presence of iron-containing metal fragments in the body.
  • Unresolved pre-existing neurological deficit.

 

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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