Safety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation (STELLAR)

Biosense Webster

Status and phase

Completed

Phase 3

Conditions

Atrial Fibrillation

Treatments

Device: Multi-Electrode RF Balloon Catheter

Study type

Interventional

Funder types

Industry

Identifiers

NCT03683030

BWI_2017_04

Details and patient eligibility

About

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.

Full description

The STELLAR study is a pivotal, prospective, multicenter, single-arm, clinical evaluation of the Multi-Electrode RF Balloon catheter. The study will evaluate the safety and effectiveness of the Multi-Electrode RF Balloon catheter used for ablation in patients with paroxysmal atrial fibrillation (PAF).

Enrollment

397 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

Diagnosed with Symptomatic Paroxysmal Atrial Fibrillation.
1. At least two symptomatic AF episodes within last six months from enrollment.
2. 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.

Key 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.