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

October 9, 2025 updated by: Biosense Webster, Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
397

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
Time Frame: Within 7 days post-procedure (Day of procedure = Day 0)
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
Time Frame: From Day 91 up to Day 365 post-procedure (Day of procedure = Day 0)
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Acute Procedural Success
Time Frame: Day 0 (day of procedure)
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
Time Frame: From Day 91 up to Day 365 post-procedure (Day of procedure = Day 0)
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
Time Frame: From Day 91 up to Day 365 post-procedure (Day of procedure = Day 0)
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
Time Frame: Baseline, Month 12
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
Time Frame: From Day 91 up to Day 365 post-procedure (Day of procedure = Day 0)
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biosense Webster, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 22, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 18, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 18, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 14, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 25, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 20, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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