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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03683030
Recruitment Status : Recruiting
First Posted : September 25, 2018
Last Update Posted : January 9, 2020
Sponsor:
Information provided by (Responsible Party):
Biosense Webster, Inc.

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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Device: Radiofrequency Ablation Phase 3

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 640 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation (STELLAR)
Actual Study Start Date : October 22, 2018
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : April 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment Group
Ablation with Multi-electrode Radiofrequency (RF) Balloon Catheter
Device: Radiofrequency Ablation
RF ablation using the multi-electrode radiofrequency balloon catheter




Primary Outcome Measures :
  1. Incidence of early onset Primary Adverse Events [ Time Frame: 7 days ]
    Primary Adverse Events (PAEs) occuring within 7 days of an ablation procedure which uses the Multi-Electrode Radiofrequency Balloon Catheter. (Including atrio-esophageal fistula and PV stenosis occurring greater than seven (7) days post ablation procedure.)

  2. Freedom of arrhythmia recurrence [ Time Frame: 3 - 12 months ]
    The primary effectiveness endpoint for this study will be freedom from documented asymptomatic and symptomatic Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03683030


Contacts
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Contact: Betzi Zafra (949) 413-8806 bzafra@its.jnj.com

Locations
Show Show 35 study locations
Sponsors and Collaborators
Biosense Webster, Inc.
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Responsible Party: Biosense Webster, Inc.
ClinicalTrials.gov Identifier: NCT03683030    
Other Study ID Numbers: BWI_2017_04
First Posted: September 25, 2018    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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
URL: http://yoda.yale.edu

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Biosense Webster, Inc.:
Interventional
Radiofrequency Ablation
Paroxysmal Atrial Fibrillation
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes