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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03683030
Recruitment Status : Active, not recruiting
First Posted : September 25, 2018
Last Update Posted : October 5, 2021
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)
Actual Enrollment : 397 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

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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


Locations
Show Show 41 study locations
Sponsors and Collaborators
Biosense Webster, Inc.
Investigators
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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: Sung Lee, MD Medstar Washington Hospital Center
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 Saint Luke's Hospital of Kansas City
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 - Anschutz Medical Campus
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
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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: October 5, 2021
Last Verified: October 2021
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