AzTrials
AzTrials

Atrial FibrillationPhase 3STELLARNCT03683030

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

A Phase 3 study testing Multi-Electrode RF Balloon Catheter in people with Atrial Fibrillation, run by Biosense Webster, Inc. at 41 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Atrial Fibrillation
What is being tested?
Multi-Electrode RF Balloon Catheter
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
397 participants
Where
41 sitesin 3 countries
Study dates
22 Oct 2018to 18 Feb 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 18Show fewer
  • 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.

Trial locations and contacts

41 sites in 3 countries.

41 sites in 3 countries

United States37 sites

  • Piedmont Hospital

    Atlanta, Georgia, 30309

  • Emory St Joseph's Hospital

    Atlanta, Georgia, 30342

  • University Of Colorado Anschutz Medical Campus

    Aurora, Colorado, 80045

  • Texas Cardiac Arrhythmia Research Foundation

    Austin, Texas, 78705

  • The Johns Hopkins Hospital

    Baltimore, Maryland, 21287

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Trident Medical Center

    Charleston, South Carolina, 29406

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

  • The Ohio State University

    Columbus, Ohio, 43210

  • Doylestown Hospital

    Doylestown, Pennsylvania, 18901

  • Inova Health Care Services

    Falls Church, Virginia, 22042

  • Spectrum Health System

    Grand Rapids, Michigan, 49503

  • CHI Baylor St. Lukes Medical Center

    Houston, Texas, 77030

  • Baptist Health Research Institute

    Jacksonville, Florida, 32207

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 92618

  • Kettering Medical Center

    Kettering, Ohio, 45429

  • University of Southern California

    Los Angeles, California, 90033

  • Med Center of the Rockies

    Loveland, Colorado, 80538

  • Morristown Medical Center

    Morristown, New Jersey, 07960

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Yale New Haven Hospital

    New Haven, Connecticut, 06520

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Lenox Hill Hospital - Northwell Health

    New York, New York, 10075

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California, 92618

  • AdventHealth Orlando

    Orlando, Florida, 32804.

  • Kansas City Arrhythmia Research

    Overland Park, Kansas, 66215

  • Phoenix Cardiovascular Research Group

    Phoenix, Arizona, 85018

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • Baylor Scott & White The Heart Hospital - Plano

    Plano, Texas, 75093

  • The Valley Hospital

    Ridgewood, New Jersey, 07450

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Mercy General Hospital

    Sacramento, California, 95819

  • Methodist Texsan Hospital

    San Antonio, Texas, 78201

  • Swedish Medical Center

    Seattle, Washington, 98122

  • Oklahoma Heart

    Tulsa, Oklahoma, 74101

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

Other trials in United States

China2 sites

  • Sir Run Run Shaw Hospital

    Hangzhou, Zhejiang, 310020

  • Ruijin Hospital

    Rui Jin Er Road, Shanghai Municipality, 200025

Other trials in China

Italy2 sites

  • Ospedale "F. Miulli"

    Bari

  • Policlinico Di San Donato Milanese

    Milanesi, MI

Other trials in Italy

About this study

Official title: 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.

Read the 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).

Being tested
Multi-Electrode RF Balloon Catheter
Keywords
Interventional, Radiofrequency Ablation, Paroxysmal Atrial Fibrillation
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multi-Electrode RF Balloon CatheterDevice

    Also called HELIOSTAR

    Multi-Electrode RF Balloon Catheter will be inserted

Study groups in NCT03683030
Study groupRoleWhat they receive
Treatment GroupExperimentalAblation using Multi-electrode Radiofrequency (RF) Balloon Catheter (HELIOSTAR).
Receives: Device: Multi-Electrode RF Balloon Catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Within 7 days post-procedure (Day of procedure = Day 0)

  2. 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.

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

Secondary outcomes (5)

  1. 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).

    Measured: Day 0 (day of procedure)

  2. 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.

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

  3. 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.

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

  4. 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).

    Measured: Baseline, Month 12

  5. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2018
  2. Study start22 Oct 2018
  3. Primary completion18 Feb 2022
  4. Study completion18 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
397 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03683030
Sponsor's protocol ID
BWI_2017_04
Acronym
STELLAR
Status last verified
Oct 2025
First submitted
14 Sep 2018
Last updated
20 Oct 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: 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

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.

    PubMed 39686569

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Multi-Electrode RF Balloon Catheter in people with Atrial Fibrillation, run by Biosense Webster, Inc. at 41 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in United States, China, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03683030, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in