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

Atrial Fibrillation Clinical Trial

— STELLAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03683030
• Other study ID #: BWI_2017_04
• Status: Completed
• Phase: Phase 3
• Start date: October 22, 2018
• Est. completion date: February 18, 2022

Study information

• Verified date: June 2023
• Source: Biosense Webster, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 397
• Est. completion date: February 18, 2022
• Est. primary completion date: February 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• Multi-Electrode RF Balloon Catheter
Multi-Electrode RF Balloon Catheter will be inserted

Locations

Country	Name	City	State
China	Sir Run Run Shaw Hospital	Hangzhou	Zhejiang
China	Ruijin Hospital	Rui Jin Er Road	Shanghai
Italy	Ospedale "F. Miulli"	Bari
Italy	Policlinico Di San Donato Milanese	Milanese	MI
United States	Emory St Joseph's Hospital	Atlanta	Georgia
United States	Piedmont Hospital	Atlanta	Georgia
United States	University Of Colorado Anschutz Medical Campus	Aurora	Colorado
United States	Texas Cardiac Arrhythmia Research Foundation	Austin	Texas
United States	The Johns Hopkins Hospital	Baltimore	Maryland
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Trident Medical Center	Charleston	South Carolina
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	The Ohio State University	Columbus	Ohio
United States	Doylestown Hospital	Doylestown	Pennsylvania
United States	Inova Health Care Services	Falls Church	Virginia
United States	Spectrum Health System	Grand Rapids	Michigan
United States	CHI Baylor St. Lukes Medical Center	Houston	Texas
United States	Baptist Health Research Institute	Jacksonville	Florida
United States	Saint Luke's Hospital of Kansas City	Kansas City	Missouri
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Kettering Medical Center	Kettering	Ohio
United States	University of Southern California	Los Angeles	California
United States	Med Center of the Rockies	Loveland	Colorado
United States	Morristown Medical Center	Morristown	New Jersey
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Yale New Haven Hospital	New Haven	Connecticut
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	Lenox Hill Hospital - Northwell Health	New York	New York
United States	Hoag Memorial Hospital Presbyterian	Newport Beach	California
United States	AdventHealth Orlando	Orlando	Florida
United States	Kansas City Arrhythmia Research	Overland Park	Kansas
United States	Phoenix Cardiovascular Research Group	Phoenix	Arizona
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Baylor Scott & White The Heart Hospital - Plano	Plano	Texas
United States	The Valley Hospital	Ridgewood	New Jersey
United States	Mayo Clinic	Rochester	Minnesota
United States	Mercy General Hospital	Sacramento	California
United States	Methodist Texsan Hospital	San Antonio	Texas
United States	Swedish Medical Center	Seattle	Washington
United States	Oklahoma Heart	Tulsa	Oklahoma
United States	MedStar Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Biosense Webster, Inc.

Countries where clinical trial is conducted

United States,  China,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of early onset Primary Adverse Events	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.)	7 days
Primary	Freedom of arrhythmia recurrence	The primary effectiveness endpoint for this study will be freedom from documented asymptomatic and symptomatic Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter.	3 - 12 months