Safety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation
NCT ID: NCT03683030
Last Updated: 2025-10-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
397 participants
INTERVENTIONAL
2018-10-22
2022-02-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment Group
Ablation using Multi-electrode Radiofrequency (RF) Balloon Catheter (HELIOSTAR).
Multi-Electrode RF Balloon Catheter
Multi-Electrode RF Balloon Catheter will be inserted
Interventions
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Multi-Electrode RF Balloon Catheter
Multi-Electrode RF Balloon Catheter will be inserted
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Biosense Webster, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Andrea Natale, MD
Role: PRINCIPAL_INVESTIGATOR
Texas Cardiac Arrhythmia Research Foundation
Srinivas Dukkipati, MD
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Moussa Mansour, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
J. Brian Deville, MD
Role: PRINCIPAL_INVESTIGATOR
Baylor Research Institute
Sandeep Goysl, MD
Role: PRINCIPAL_INVESTIGATOR
Piedmont Hospital
Arash Aryana, MD
Role: PRINCIPAL_INVESTIGATOR
Mercy General Hospital
Javier Roman-Gonzalez, MD
Role: PRINCIPAL_INVESTIGATOR
Methodist Texsan Hospital
Hugh Calkins, MD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Suneet Mittal, MD
Role: PRINCIPAL_INVESTIGATOR
The Valley Hospital
Bradley Knight, MD
Role: PRINCIPAL_INVESTIGATOR
Northwestern Memorial Hospital
Anshul Patel, MD
Role: PRINCIPAL_INVESTIGATOR
Emory St Joseph's Hospital
Sung Lee, MD
Role: PRINCIPAL_INVESTIGATOR
Medstar Health Research Institute
Douglas Packer, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Michael Panutich, MD
Role: PRINCIPAL_INVESTIGATOR
Hoag Memorial Hospital Presbyterian
Robert Sangrigoli, MD
Role: PRINCIPAL_INVESTIGATOR
Doylestown Hospital
Sharon Shen, MD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt Medical Center
Dhanunjaya Lakkireddy, MD
Role: PRINCIPAL_INVESTIGATOR
Kansas City Arrhythmia Research
Haseeb Jafri, MD
Role: PRINCIPAL_INVESTIGATOR
Kettering Medical Center
Timothy Mahoney, MD
Role: PRINCIPAL_INVESTIGATOR
Morristown Medical Center
Stavros Mountantonakis, MD
Role: PRINCIPAL_INVESTIGATOR
Lenox Hill Hospital
Massimo Grimaldi, MD
Role: PRINCIPAL_INVESTIGATOR
Miulli General Hospital
James Freeman, MD
Role: PRINCIPAL_INVESTIGATOR
Yale New Haven Hospital
Andy Voigt, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh Medical Center
Venkata Sagi, MD
Role: PRINCIPAL_INVESTIGATOR
Baptist Health Research Institute
Anil Bhandari, MD
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Haroon Rashid, MD
Role: PRINCIPAL_INVESTIGATOR
Inova Health Care Services
Naushad Shaik, MD
Role: PRINCIPAL_INVESTIGATOR
AdventHealth Orlando
Alan Wimmer, MD
Role: PRINCIPAL_INVESTIGATOR
St. Luke's Hospital, Kansas City, Missouri
Frank Cuoco, MD
Role: PRINCIPAL_INVESTIGATOR
Trident Medical Center
Madhu Reddy, MD
Role: PRINCIPAL_INVESTIGATOR
University of Kansas Medical Center
Ryan Aleong, MD
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Andre Gauri, MD
Role: PRINCIPAL_INVESTIGATOR
Spectrum Health System
Raul Weiss, MD
Role: PRINCIPAL_INVESTIGATOR
Ohio State University
Craig Cameron, MD
Role: PRINCIPAL_INVESTIGATOR
Oklahoma Heart
MArwan Bahu, MD
Role: PRINCIPAL_INVESTIGATOR
Phoenix Cardiovascular Research Group
Darryl Wells, MD
Role: PRINCIPAL_INVESTIGATOR
Swedish Medical Center
Ethan Ellis, MD
Role: PRINCIPAL_INVESTIGATOR
Med Center of the Rockies
Carlo Pappone, MD
Role: PRINCIPAL_INVESTIGATOR
Policlinico Di San Donato Milanese
Abdi Rasekh, MD
Role: PRINCIPAL_INVESTIGATOR
CHI Baylor St. Lukes Medical Center
Liqun Wu, MD
Role: PRINCIPAL_INVESTIGATOR
Ruijin Hospital
Chenyang Jiang, MD
Role: PRINCIPAL_INVESTIGATOR
Sir Run Run Shaw Hospital
Locations
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Phoenix Cardiovascular Research Group
Phoenix, Arizona, United States
University of Southern California
Los Angeles, California, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
Mercy General Hospital
Sacramento, California, United States
University Of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Med Center of the Rockies
Loveland, Colorado, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Baptist Health Research Institute
Jacksonville, Florida, United States
AdventHealth Orlando
Orlando, Florida, United States
Piedmont Hospital
Atlanta, Georgia, United States
Emory St Joseph's Hospital
Atlanta, Georgia, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Kansas City Arrhythmia Research
Overland Park, Kansas, United States
The Johns Hopkins Hospital
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Spectrum Health System
Grand Rapids, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States
Morristown Medical Center
Morristown, New Jersey, United States
The Valley Hospital
Ridgewood, New Jersey, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Lenox Hill Hospital - Northwell Health
New York, New York, United States
The Ohio State University
Columbus, Ohio, United States
Kettering Medical Center
Kettering, Ohio, United States
Oklahoma Heart
Tulsa, Oklahoma, United States
Doylestown Hospital
Doylestown, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Trident Medical Center
Charleston, South Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, United States
CHI Baylor St. Lukes Medical Center
Houston, Texas, 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
Swedish Medical Center
Seattle, Washington, United States
Ruijin Hospital
Rui Jin Er Road, Shanghai Municipality, China
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, China
Policlinico Di San Donato Milanese
Milanesi, MI, Italy
Ospedale "F. Miulli"
Bari, , Italy
Countries
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References
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Goyal SK, Pappone C, Grimaldi M, Lee SW, Mountantonakis S, DeVille JB, Sagi VS, Jiang CY, Jafri H, Wimmer AP, Wu LQ, Dukkipati S, Rashid H, Calkins H, Mansour M, Roman-Gonzalez J, Natale A, Ciconte G, Aryana A; STELLAR investigators. Multielectrode Radiofrequency Balloon Catheter for Paroxysmal Atrial Fibrillation: Results From the Global, Multicenter, STELLAR Study. J Cardiovasc Electrophysiol. 2025 Feb;36(2):376-386. doi: 10.1111/jce.16524. Epub 2024 Dec 16.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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BWI_2017_04
Identifier Type: -
Identifier Source: org_study_id
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