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

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

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: Multi-Electrode RF Balloon Catheter

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).

• Study Type: Interventional
• Enrollment (Actual): 397
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Shanghai Municipality
    • Rui Jin Er Road, Shanghai Municipality, China, 200025
      • Ruijin Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310020
      • Sir Run Run Shaw Hospital
• Italy
  • Bari, Italy
    • Ospedale "F. Miulli"
  • MI
    • Milanesi, MI, Italy
      • Policlinico Di San Donato Milanese
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85018
      • Phoenix Cardiovascular Research Group
  • California
    • Los Angeles, California, United States, 90033
      • University of Southern California
    • Newport Beach, California, United States, 92618
      • Hoag Memorial Hospital Presbyterian
    • Sacramento, California, United States, 95819
      • Mercy General Hospital
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Anschutz Medical Campus
    • Loveland, Colorado, United States, 80538
      • Med Center of the Rockies
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale New Haven Hospital
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20010
      • MedStar Washington Hospital Center
  • Florida
    • Jacksonville, Florida, United States, 32207
      • Baptist Health Research Institute
    • Orlando, Florida, United States, 32804.
      • AdventHealth Orlando
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Piedmont Hospital
    • Atlanta, Georgia, United States, 30342
      • Emory St Joseph's Hospital
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial Hospital
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
    • Overland Park, Kansas, United States, 66215
      • Kansas City Arrhythmia Research
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • The Johns Hopkins Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
      • Spectrum Health System
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Missouri
    • Kansas City, Missouri, United States, 92618
      • Saint Luke's Hospital of Kansas City
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Morristown Medical Center
    • Ridgewood, New Jersey, United States, 07450
      • The Valley Hospital
  • New York
    • New York, New York, United States, 10029
      • Icahn School Of Medicine At Mount Sinai
    • New York, New York, United States, 10075
      • Lenox Hill Hospital - Northwell Health
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University
    • Kettering, Ohio, United States, 45429
      • Kettering Medical Center
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74101
      • Oklahoma Heart
  • Pennsylvania
    • Doylestown, Pennsylvania, United States, 18901
      • Doylestown Hospital
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
  • South Carolina
    • Charleston, South Carolina, United States, 29406
      • Trident Medical Center
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Texas
    • Austin, Texas, United States, 78705
      • Texas Cardiac Arrhythmia Research Foundation
    • Houston, Texas, United States, 77030
      • CHI Baylor St. Lukes Medical Center
    • Plano, Texas, United States, 75093
      • Baylor Scott & White The Heart Hospital - Plano
    • San Antonio, Texas, United States, 78201
      • Methodist Texsan Hospital
  • Virginia
    • Falls Church, Virginia, United States, 22042
      • Inova Health Care Services
  • Washington
    • Seattle, Washington, United States, 98122
      • Swedish Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Any Primary Adverse Events (PAE) That Occurred Within 7 Days Following Atrial Fibrillation (AF) Ablation Procedure Using HELIOSTAR Catheter	An AE is any untoward medical occurrence in a participant whether or not related to the investigational medical device. PAEs included myocardial infarction, thromboembolism, transient ischemic attack, phrenic nerve paralysis, major vascular access complication/bleeding, pericarditis, pulmonary edema (respiratory insufficiency), stroke/cerebrovascular accident (CVA), hospitalization (initial or prolonged), device or procedure related death, atrio-esophageal fistula, pulmonary vein stenosis.	Within 7 days post-procedure (Day of procedure = Day 0)
Number of Participants With Effectiveness Success	Effectiveness success was defined as freedom from documented asymptomatic and symptomatic atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL; of unknown origin) episodes based on electrocardiographic data (greater than equal to [>=] 30 seconds on arrhythmia monitoring device) through the effectiveness evaluation period (Day 91 through Day 365 post index procedure) and freedom from the following failure modes : freedom from acute procedural failure, freedom from non-study catheter failure, freedom from repeat ablation failure, freedom from direct Current (DC) cardioversion failure, freedom from recurrence (captured on 12-lead electrocardiogram [ECG]) failure, and freedom from anti-arrhythmic drug failure. AFL of unknown origin was defined as all AFL except those Cavo-Tricuspid Isthmus (CTI) dependent AFL as confirmed by accepted electrophysiology (EP) maneuvers (example, entrainment or activation mapping) in an EP study.	From Day 91 up to Day 365 post-procedure (Day of procedure = Day 0)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Acute Procedural Success	Acute procedural success is defined as confirmation of entrance block in clinically relevant pulmonary veins (PVs) (all PVs except those that were silent and/or could not be cannulated) after adenosine and/or isoproterenol challenge (with or without the use of a focal catheter).	Day 0 (day of procedure)
Percentage of Participants With Alternative 12-Month Success	Alternative 12-month success is defined as freedom from documented symptomatic AF/AT/AFL (of unknown origin) episodes based on electrocardiographic data (>=30 seconds on arrhythmia monitoring device) through the effectiveness evaluation period (Day 91 through Day 365) and freedom from the following failure modes: freedom from acute procedural failure, freedom from non-study catheter failure, freedom from repeat ablation failure, freedom from DC Cardioversion failure, freedom from recurrence (captured on 12-lead ECG) failure, and freedom from anti-arrhythmic drug failure. AFL of unknown origin is defined as all AFL except those CTI dependent AFL as confirmed by accepted EP maneuvers (e.g. entrainment or activation mapping) in an EP study.	From Day 91 up to Day 365 post-procedure (Day of procedure = Day 0)
Percentage of Participants With 12-Month Symptomatic Recurrence	12-month symptomatic recurrence endpoint is defined as freedom from documented symptomatic AF/AT/AFL (of unknown origin) episodes based on electrocardiographic data (>=30 seconds on arrhythmia monitoring device) through the effectiveness evaluation period (Day 91 through Day 365) in participants regardless of antiarrhythmic drug (AAD) use and freedom from the following failure modes: freedom from acute procedural failure, freedom from non-study catheter failure, freedom from repeat ablation failure, freedom from DC Cardioversion failure, and freedom from recurrence (captured on 12-lead ECG) failure. AFL of unknown origin is defined as all AFL except those CTI dependent AFL as confirmed by accepted EP maneuvers (e.g. entrainment or activation mapping) in an EP study.	From Day 91 up to Day 365 post-procedure (Day of procedure = Day 0)
Change From Baseline in Quality of Life as Assessed by Atrial Fibrillation Effect on Quality-of-Life (AFEQT) Scale Score	AFEQT questionnaire is an atrial fibrillation-specific health-related quality of life (HRQoL) questionnaire designed to assess the impact of atrial fibrillation on participant's HRQoL. The questionnaire includes 20 questions on a 7-point Likert scale. Questions 1 to 18 evaluated HRQoL and questions 19 to 20 related to participant's satisfaction with treatment. Overall scores ranged from 0 to 100, where 0 corresponds to complete disability (or responding "extremely" limited, difficult or bothersome to all questions answered), while a score of 100 corresponds to no disability (or responding "not at all" limited, difficult or bothersome to all questions answered). Therefore, a positive change in score corresponds to improvement in QoL. Total score was calculated using AFEQT formula: 100 minus ([sum of severity for all questions answered minus number of questions answered]*100 / total number questions answered*6).	Baseline, Month 12
Percentage of Participants With 12-Month Single Procedure Success	12-month single procedure success is defined as freedom from documented symptomatic AF/AT/AFL (of unknown origin) episodes based on electrocardiographic data (>=30 seconds on arrhythmia monitoring device) through the effectiveness evaluation period (Day 91 through Day 365) and freedom from the following failure modes: freedom from acute procedural failure, freedom from non-study catheter failure, freedom from repeat ablation failure, freedom from DC Cardioversion failure, freedom from recurrence (captured on 12-lead ECG) failure, and freedom from anti-arrhythmic drug failure. AFL of unknown origin is defined as all AFL except those CTI dependent AFL as confirmed by accepted EP maneuvers (e.g. entrainment or activation mapping) in an EP study.	From Day 91 up to Day 365 post-procedure (Day of procedure = Day 0)

Collaborators and Investigators

• Sponsor: Biosense Webster, Inc.
• Investigators: Principal Investigator: Andrea Natale, MD, Texas Cardiac Arrhythmia Research Foundation; Principal Investigator: Srinivas Dukkipati, MD, Icahn School Of Medicine At Mount Sinai; Principal Investigator: Moussa Mansour, MD, Massachusetts General Hospital; Principal Investigator: J. Brian Deville, MD, Baylor Research Institute; Principal Investigator: Sandeep Goysl, MD, Piedmont Hospital; Principal Investigator: Arash Aryana, MD, Mercy General Hospital; Principal Investigator: Javier Roman-Gonzalez, MD, Methodist Texsan Hospital; Principal Investigator: Hugh Calkins, MD, Johns Hopkins University; Principal Investigator: Suneet Mittal, MD, The Valley Hospital; Principal Investigator: Bradley Knight, MD, Northwestern Memorial Hospital; Principal Investigator: Anshul Patel, MD, Emory St Joseph's Hospital; Principal Investigator: Douglas Packer, MD, Mayo Clinic; Principal Investigator: Michael Panutich, MD, Hoag Memorial Hospital Presbyterian; Principal Investigator: Robert Sangrigoli, MD, Doylestown Hospital; Principal Investigator: Sharon Shen, MD, Vanderbilt Medical Center; Principal Investigator: Dhanunjaya Lakkireddy, MD, Kansas City Arrhythmia Research; Principal Investigator: Haseeb Jafri, MD, Kettering Medical Center; Principal Investigator: Timothy Mahoney, MD, Morristown Medical Center; Principal Investigator: Stavros Mountantonakis, MD, Lenox Hill Hospital; Principal Investigator: Massimo Grimaldi, MD, Miulli General Hospital; Principal Investigator: James Freeman, MD, Yale New Haven Hospital; Principal Investigator: Andy Voigt, MD, University of Pittsburgh Medical Center; Principal Investigator: Venkata Sagi, MD, Baptist Health Research Institute; Principal Investigator: Anil Bhandari, MD, University of Southern California; Principal Investigator: Haroon Rashid, MD, Inova Health Care Services; Principal Investigator: Naushad Shaik, MD, AdventHealth Orlando; Principal Investigator: Frank Cuoco, MD, Trident Medical Center; Principal Investigator: Madhu Reddy, MD, University of Kansas Medical Center; Principal Investigator: Andre Gauri, MD, Spectrum Health System; Principal Investigator: Raul Weiss, MD, Ohio State University; Principal Investigator: Craig Cameron, MD, Oklahoma Heart; Principal Investigator: MArwan Bahu, MD, Phoenix Cardiovascular Research Group; Principal Investigator: Darryl Wells, MD, Swedish Medical Center; Principal Investigator: Ethan Ellis, MD, Med Center of the Rockies; Principal Investigator: Carlo Pappone, MD, Policlinico Di San Donato Milanese; Principal Investigator: Abdi Rasekh, MD, CHI Baylor St. Lukes Medical Center; Principal Investigator: Liqun Wu, MD, Ruijin Hospital; Principal Investigator: Chenyang Jiang, MD, Sir Run Run Shaw Hospital; Principal Investigator: Sung Lee, MD, Medstar Health Research Institute; Principal Investigator: Alan Wimmer, MD, St. Luke's Hospital, Kansas City, Missouri; Principal Investigator: Ryan Aleong, MD, University of Colorado, Denver

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2018
• Primary Completion (Actual): February 18, 2022
• Study Completion (Actual): February 18, 2022

Study Registration Dates

• First Submitted: September 14, 2018
• First Submitted That Met QC Criteria: September 21, 2018
• First Posted (Actual): September 25, 2018

Study Record Updates

• Last Update Posted (Actual): October 20, 2025
• Last Update Submitted That Met QC Criteria: October 9, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Interventional; Radiofrequency Ablation; Paroxysmal Atrial Fibrillation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation
• Other Study ID Numbers: BWI_2017_04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Johnson & Johnson Medical Devices Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes