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

NCT03683030 | Completed Phase 3 Results DMC FDA Device

• 1 other identifier: BWI_2017_04
• Study Type: interventional
• Target: 397
• Locations: 3 countries
• Sites: 41

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.

Conditions

Atrial Fibrillation

Keywords

Interventional; Radiofrequency Ablation; Paroxysmal Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Percentage of Participants With Acute Procedural Success

  Day 0 (day of procedure)

• Percentage of Participants With Alternative 12-Month Success

  From Day 91 up to Day 365 post-procedure (Day of procedure = Day 0)

• Percentage of Participants With 12-Month Symptomatic Recurrence

  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

  Baseline, Month 12

• Percentage of Participants With 12-Month Single Procedure Success

  From Day 91 up to Day 365 post-procedure (Day of procedure = Day 0)

Study Arms (1)

Treatment Group

EXPERIMENTAL

Ablation using Multi-electrode Radiofrequency (RF) Balloon Catheter (HELIOSTAR).

Device: Multi-Electrode RF Balloon Catheter

Interventions

Multi-Electrode RF Balloon Catheter DEVICE

Multi-Electrode RF Balloon Catheter will be inserted

Also known as: HELIOSTAR

Treatment Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biosense Webster, Inc.: lead

Study Sites (41)

Phoenix Cardiovascular Research Group

Phoenix, Arizona, 85018, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92618, United States

Location

Mercy General Hospital

Sacramento, California, 95819, United States

Location

University Of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Med Center of the Rockies

Loveland, Colorado, 80538, United States

Location

Yale New Haven Hospital

New Haven, Connecticut, 06520, United States

Location

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Baptist Health Research Institute

Jacksonville, Florida, 32207, United States

Location

AdventHealth Orlando

Orlando, Florida, 32804., United States

Location

Piedmont Hospital

Atlanta, Georgia, 30309, United States

Location

Emory St Joseph's Hospital

Atlanta, Georgia, 30342, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Kansas City Arrhythmia Research

Overland Park, Kansas, 66215, United States

Location

The Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Spectrum Health System

Grand Rapids, Michigan, 49503, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 92618, United States

Location

Morristown Medical Center

Morristown, New Jersey, 07960, United States

Location

The Valley Hospital

Ridgewood, New Jersey, 07450, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Lenox Hill Hospital - Northwell Health

New York, New York, 10075, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Kettering Medical Center

Kettering, Ohio, 45429, United States

Location

Oklahoma Heart

Tulsa, Oklahoma, 74101, United States

Location

Doylestown Hospital

Doylestown, Pennsylvania, 18901, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Trident Medical Center

Charleston, South Carolina, 29406, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, 78705, United States

Location

CHI Baylor St. Lukes Medical Center

Houston, Texas, 77030, United States

Location

Baylor Scott & White The Heart Hospital - Plano

Plano, Texas, 75093, United States

Location

Methodist Texsan Hospital

San Antonio, Texas, 78201, United States

Location

Inova Health Care Services

Falls Church, Virginia, 22042, United States

Location

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

Ruijin Hospital

Rui Jin Er Road, Shanghai Municipality, 200025, China

Location

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, 310020, China

Location

Policlinico Di San Donato Milanese

Milanesi, MI, Italy

Location

Ospedale "F. Miulli"

Bari, Italy

Location

Related Publications (1)

• 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.

  PMID: 39686569 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Senior Director Clinical Research
• Organization: Biosense Webster, Inc.

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• 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

• Sung Lee, MD

  Medstar Health Research Institute

  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

• Alan Wimmer, MD

  St. Luke's Hospital, Kansas City, Missouri

  PRINCIPAL INVESTIGATOR

• Frank Cuoco, MD

  Trident Medical Center

  PRINCIPAL INVESTIGATOR

• Madhu Reddy, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

• Ryan Aleong, MD

  University of Colorado, Denver

  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

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2018
• First Posted: September 25, 2018
• Study Start: October 22, 2018
• Primary Completion: February 18, 2022
• Study Completion: February 18, 2022
• Last Updated: October 20, 2025
• Results First Posted: August 15, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share

Locations

US (37); CN (2); IT (2)