Back to resultsSafety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation (STELLAR)
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Multi-Electrode RF Balloon Catheter
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring Interventional, Radiofrequency Ablation, Paroxysmal Atrial Fibrillation
Eligibility Criteria
Key Inclusion Criteria:
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.
Sites / Locations
- Phoenix Cardiovascular Research Group
- University of Southern California
- Hoag Memorial Hospital Presbyterian
- Mercy General Hospital
- University Of Colorado Anschutz Medical Campus
- Med Center of the Rockies
- Yale New Haven Hospital
- MedStar Washington Hospital Center
- Baptist Health Research Institute
- AdventHealth Orlando
- Piedmont Hospital
- Emory St Joseph's Hospital
- Northwestern Memorial Hospital
- University of Kansas Medical Center
- Kansas City Arrhythmia Research
- The Johns Hopkins Hospital
- Massachusetts General Hospital
- Spectrum Health System
- Mayo Clinic
- Saint Luke's Hospital of Kansas City
- Morristown Medical Center
- The Valley Hospital
- Icahn School of Medicine at Mount Sinai
- Lenox Hill Hospital - Northwell Health
- The Ohio State University
- Kettering Medical Center
- Oklahoma Heart
- Doylestown Hospital
- University of Pittsburgh Medical Center
- Trident Medical Center
- Vanderbilt University Medical Center
- Texas Cardiac Arrhythmia Research Foundation
- CHI Baylor St. Lukes Medical Center
- Baylor Scott & White The Heart Hospital - Plano
- Methodist Texsan Hospital
- Inova Health Care Services
- Swedish Medical Center
- Ruijin Hospital
- Sir Run Run Shaw Hospital
- Policlinico Di San Donato Milanese
- Ospedale "F. Miulli"
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment Group
Arm Description
Ablation using Multi-electrode Radiofrequency (RF) Balloon Catheter (HELIOSTAR).
Outcomes
Primary Outcome Measures
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.)
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03683030
First Posted
September 14, 2018
Last Updated
June 2, 2023
Sponsor
Biosense Webster, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03683030
Brief Title
Safety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation
Acronym
STELLAR
Official Title
Safety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation (STELLAR)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
October 22, 2018 (Actual)
Primary Completion Date
February 18, 2022 (Actual)
Study Completion Date
February 18, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biosense Webster, Inc.
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Interventional, Radiofrequency Ablation, Paroxysmal Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
397 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
Ablation using Multi-electrode Radiofrequency (RF) Balloon Catheter (HELIOSTAR).
Intervention Type
Device
Intervention Name(s)
Multi-Electrode RF Balloon Catheter
Other Intervention Name(s)
HELIOSTAR
Intervention Description
Multi-Electrode RF Balloon Catheter will be inserted
Primary Outcome Measure Information:
Title
Incidence of early onset Primary Adverse Events
Description
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.)
Time Frame
7 days
Title
Freedom of arrhythmia recurrence
Description
The primary effectiveness endpoint for this study will be freedom from documented asymptomatic and symptomatic Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter.
Time Frame
3 - 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Natale, MD
Organizational Affiliation
Texas Cardiac Arrhythmia Research Foundation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Srinivas Dukkipati, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Moussa Mansour, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
J. Brian Deville, MD
Organizational Affiliation
Baylor Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sandeep Goysl, MD
Organizational Affiliation
Piedmont Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Arash Aryana, MD
Organizational Affiliation
Mercy General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Javier Roman-Gonzalez, MD
Organizational Affiliation
Methodist Texsan Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hugh Calkins, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Suneet Mittal, MD
Organizational Affiliation
The Valley Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bradley Knight, MD
Organizational Affiliation
Northwestern Memorial Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anshul Patel, MD
Organizational Affiliation
Emory St Joseph's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sung Lee, MD
Organizational Affiliation
Medstar Washington Hospital Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Douglas Packer, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Panutich, MD
Organizational Affiliation
Hoag Memorial Hospital Presbyterian
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert Sangrigoli, MD
Organizational Affiliation
Doylestown Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sharon Shen, MD
Organizational Affiliation
Vanderbilt Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dhanunjaya Lakkireddy, MD
Organizational Affiliation
Kansas City Arrhythmia Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Haseeb Jafri, MD
Organizational Affiliation
Kettering Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Timothy Mahoney, MD
Organizational Affiliation
Morristown Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stavros Mountantonakis, MD
Organizational Affiliation
Lenox Hill Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Massimo Grimaldi, MD
Organizational Affiliation
Miulli General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
James Freeman, MD
Organizational Affiliation
Yale New Haven Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andy Voigt, MD
Organizational Affiliation
University of Pittsburgh Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Venkata Sagi, MD
Organizational Affiliation
Baptist Health Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anil Bhandari, MD
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Haroon Rashid, MD
Organizational Affiliation
Inova Health Care Services
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Naushad Shaik, MD
Organizational Affiliation
AdventHealth Orlando
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alan Wimmer, MD
Organizational Affiliation
Saint Luke's Hospital of Kansas City
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Frank Cuoco, MD
Organizational Affiliation
Trident Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Madhu Reddy, MD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ryan Aleong, MD
Organizational Affiliation
University of Colorado - Anschutz Medical Campus
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andre Gauri, MD
Organizational Affiliation
Spectrum Health System
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Raul Weiss, MD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Craig Cameron, MD
Organizational Affiliation
Oklahoma Heart
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
MArwan Bahu, MD
Organizational Affiliation
Phoenix Cardiovascular Research Group
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Darryl Wells, MD
Organizational Affiliation
Swedish Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ethan Ellis, MD
Organizational Affiliation
Med Center of the Rockies
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carlo Pappone, MD
Organizational Affiliation
Policlinico Di San Donato Milanese
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Abdi Rasekh, MD
Organizational Affiliation
CHI Baylor St. Lukes Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Liqun Wu, MD
Organizational Affiliation
Ruijin Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chenyang Jiang, MD
Organizational Affiliation
Sir Run Run Shaw Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Phoenix Cardiovascular Research Group
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Hoag Memorial Hospital Presbyterian
City
Newport Beach
State/Province
California
ZIP/Postal Code
92618
Country
United States
Facility Name
Mercy General Hospital
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
University Of Colorado Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Med Center of the Rockies
City
Loveland
State/Province
Colorado
ZIP/Postal Code
80538
Country
United States
Facility Name
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
MedStar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Baptist Health Research Institute
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
AdventHealth Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804.
Country
United States
Facility Name
Piedmont Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Emory St Joseph's Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Kansas City Arrhythmia Research
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66215
Country
United States
Facility Name
The Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Spectrum Health System
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Saint Luke's Hospital of Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
92618
Country
United States
Facility Name
Morristown Medical Center
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
The Valley Hospital
City
Ridgewood
State/Province
New Jersey
ZIP/Postal Code
07450
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Lenox Hill Hospital - Northwell Health
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Kettering Medical Center
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
Oklahoma Heart
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74101
Country
United States
Facility Name
Doylestown Hospital
City
Doylestown
State/Province
Pennsylvania
ZIP/Postal Code
18901
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Trident Medical Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Texas Cardiac Arrhythmia Research Foundation
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
CHI Baylor St. Lukes Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Baylor Scott & White The Heart Hospital - Plano
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Methodist Texsan Hospital
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78201
Country
United States
Facility Name
Inova Health Care Services
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
Ruijin Hospital
City
Rui Jin Er Road
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Facility Name
Sir Run Run Shaw Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310020
Country
China
Facility Name
Policlinico Di San Donato Milanese
City
Milanese
State/Province
MI
Country
Italy
Facility Name
Ospedale "F. Miulli"
City
Bari
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
IPD Sharing URL
http://yoda.yale.edu
Learn more about this trial
Safety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation
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