Safety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation (STELLAR)
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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 |
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Recruitment Status :
Active, not recruiting
First Posted : September 25, 2018
Last Update Posted : February 23, 2022
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Sponsor:
Biosense Webster, Inc.
Information provided by (Responsible Party):
Biosense Webster, Inc.
- Study Details
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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 |
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 : | 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
MedlinePlus Genetics related topics:
Familial atrial fibrillation
MedlinePlus related topics:
Atrial Fibrillation
| Arm | Intervention/treatment |
|---|---|
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Experimental: Treatment Group
Ablation with Multi-electrode Radiofrequency (RF) Balloon Catheter
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Device: Radiofrequency Ablation
RF ablation using the multi-electrode radiofrequency balloon catheter |
Primary Outcome Measures :
- 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.)
- 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.
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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:
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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.
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 41 study locations
Sponsors and Collaborators
Biosense Webster, Inc.
Investigators
| 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 |
| 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: | February 23, 2022 |
| Last Verified: | February 2022 |
| 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 |
| 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.:
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Interventional Radiofrequency Ablation Paroxysmal Atrial Fibrillation |
Additional relevant MeSH terms:
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Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |