Safety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation
- Conditions
- Atrial Fibrillation
- Interventions
- Device: Multi-Electrode RF Balloon Catheter
- Registration Number
- NCT03683030
- Lead Sponsor
- Biosense Webster, Inc.
- Brief Summary
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.
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 397
-
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.
Key
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment Group Multi-Electrode RF Balloon Catheter Ablation using Multi-electrode Radiofrequency (RF) Balloon Catheter (HELIOSTAR).
- Primary Outcome Measures
Name Time Method Incidence of early onset Primary Adverse Events 7 days Primary Adverse Events (PAEs) occuring within 7 days of an ablation procedure which uses the Multi-Electrode Radiofrequency Balloon Catheter. (Including atrio-esophageal fistula and PV stenosis occurring greater than seven (7) days post ablation procedure.)
Freedom of arrhythmia recurrence 3 - 12 months The primary effectiveness endpoint for this study will be freedom from documented asymptomatic and symptomatic Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (41)
The Ohio State University
🇺🇸Columbus, Ohio, United States
Ospedale "F. Miulli"
🇮🇹Bari, Italy
Swedish Medical Center
🇺🇸Seattle, Washington, United States
Piedmont Hospital
🇺🇸Atlanta, Georgia, United States
Saint Luke's Hospital of Kansas City
🇺🇸Kansas City, Missouri, United States
Kettering Medical Center
🇺🇸Kettering, Ohio, United States
Baylor Scott & White The Heart Hospital - Plano
🇺🇸Plano, Texas, United States
Methodist Texsan Hospital
🇺🇸San Antonio, Texas, United States
Inova Health Care Services
🇺🇸Falls Church, Virginia, United States
Kansas City Arrhythmia Research
🇺🇸Overland Park, Kansas, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
University of Southern California
🇺🇸Los Angeles, California, United States
Hoag Memorial Hospital Presbyterian
🇺🇸Newport Beach, California, United States
Med Center of the Rockies
🇺🇸Loveland, Colorado, United States
University Of Colorado Anschutz Medical Campus
🇺🇸Aurora, Colorado, United States
Yale New Haven Hospital
🇺🇸New Haven, Connecticut, United States
MedStar Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Emory St Joseph's Hospital
🇺🇸Atlanta, Georgia, United States
AdventHealth Orlando
🇺🇸Orlando, Florida, United States
Spectrum Health System
🇺🇸Grand Rapids, Michigan, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
Morristown Medical Center
🇺🇸Morristown, New Jersey, United States
The Valley Hospital
🇺🇸Ridgewood, New Jersey, United States
CHI Baylor St. Lukes Medical Center
🇺🇸Houston, Texas, United States
Lenox Hill Hospital - Northwell Health
🇺🇸New York, New York, United States
Oklahoma Heart
🇺🇸Tulsa, Oklahoma, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Doylestown Hospital
🇺🇸Doylestown, Pennsylvania, United States
Trident Medical Center
🇺🇸Charleston, South Carolina, United States
Ruijin Hospital
🇨🇳Rui Jin Er Road, Shanghai, China
Sir Run Run Shaw Hospital
🇨🇳Hangzhou, Zhejiang, China
Mercy General Hospital
🇺🇸Sacramento, California, United States
Phoenix Cardiovascular Research Group
🇺🇸Phoenix, Arizona, United States
The Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
Texas Cardiac Arrhythmia Research Foundation
🇺🇸Austin, Texas, United States
Policlinico Di San Donato Milanese
🇮🇹Milanese, MI, Italy
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Baptist Health Research Institute
🇺🇸Jacksonville, Florida, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States