Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Treatment Group
Ablation using Multi-electrode Radiofrequency (RF) Balloon Catheter (HELIOSTAR).
  • Device: Multi-Electrode RF Balloon Catheter
    Multi-Electrode RF Balloon Catheter will be inserted
    Other names:
    • HELIOSTAR

More Details

Status
Completed
Sponsor
Biosense Webster, Inc.

Study Contact

Detailed 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).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.