Clinical trial NCT03683030: Safety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atrial Fibrillation
Keywords: Interventional
Radiofrequency Ablation
Paroxysmal Atrial Fibrillation
Lead sponsor: Biosense Webster, Inc.
Sponsor class: INDUSTRY
First posted: 2018-09-25
Enrollment: 397
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility 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.

Primary outcomes:
measure: Incidence of early onset Primary Adverse Events
timeFrame: 7 days
measure: Freedom of arrhythmia recurrence
timeFrame: 3 - 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Cardiovascular Research Group
state: Arizona
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital Presbyterian
state: California
city: Sacramento
country: United States
facility: Mercy General Hospital
state: California
city: Aurora
country: United States
facility: University Of Colorado Anschutz Medical Campus
state: Colorado
city: Loveland
country: United States
facility: Med Center of the Rockies
state: Colorado
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Jacksonville
country: United States
facility: Baptist Health Research Institute
state: Florida
city: Orlando
country: United States
facility: AdventHealth Orlando
state: Florida
city: Atlanta
country: United States
facility: Piedmont Hospital
state: Georgia
city: Atlanta
country: United States
facility: Emory St Joseph's Hospital
state: Georgia
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Overland Park
country: United States
facility: Kansas City Arrhythmia Research
state: Kansas
city: Baltimore
country: United States
facility: The Johns Hopkins Hospital
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Grand Rapids
country: United States
facility: Spectrum Health System
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Kansas City
country: United States
facility: Saint Luke's Hospital of Kansas City
state: Missouri
city: Morristown
country: United States
facility: Morristown Medical Center
state: New Jersey
city: Ridgewood
country: United States
facility: The Valley Hospital
state: New Jersey
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Lenox Hill Hospital - Northwell Health
state: New York
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Kettering
country: United States
facility: Kettering Medical Center
state: Ohio
city: Tulsa
country: United States
facility: Oklahoma Heart
state: Oklahoma
city: Doylestown
country: United States
facility: Doylestown Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Charleston
country: United States
facility: Trident Medical Center
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Research Foundation
state: Texas
city: Houston
country: United States
facility: CHI Baylor St. Lukes Medical Center
state: Texas
city: Plano
country: United States
facility: Baylor Scott & White The Heart Hospital - Plano
state: Texas
city: San Antonio
country: United States
facility: Methodist Texsan Hospital
state: Texas
city: Falls Church
country: United States
facility: Inova Health Care Services
state: Virginia
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Rui Jin Er Road
country: China
facility: Ruijin Hospital
state: Shanghai
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital
state: Zhejiang
city: Milanese
country: Italy
facility: Policlinico Di San Donato Milanese
state: MI
city: Bari
country: Italy
facility: Ospedale "F. Miulli"
Study officials:
affiliation: Texas Cardiac Arrhythmia Research Foundation
name: Andrea Natale, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Icahn School of Medicine at Mount Sinai
name: Srinivas Dukkipati, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Moussa Mansour, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Baylor Research Institute
name: J. Brian Deville, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Piedmont Hospital
name: Sandeep Goysl, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mercy General Hospital
name: Arash Aryana, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Methodist Texsan Hospital
name: Javier Roman-Gonzalez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Hugh Calkins, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Valley Hospital
name: Suneet Mittal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern Memorial Hospital
name: Bradley Knight, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory St Joseph's Hospital
name: Anshul Patel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medstar Health Research Institute
name: Sung Lee, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Douglas Packer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hoag Memorial Hospital Presbyterian
name: Michael Panutich, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Doylestown Hospital
name: Robert Sangrigoli, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt Medical Center
name: Sharon Shen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kansas City Arrhythmia Research
name: Dhanunjaya Lakkireddy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kettering Medical Center
name: Haseeb Jafri, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Morristown Medical Center
name: Timothy Mahoney, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lenox Hill Hospital
name: Stavros Mountantonakis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Miulli General Hospital
name: Massimo Grimaldi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale New Haven Hospital
name: James Freeman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh Medical Center
name: Andy Voigt, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Baptist Health Research Institute
name: Venkata Sagi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Southern California
name: Anil Bhandari, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Inova Health Care Services
name: Haroon Rashid, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AdventHealth Orlando
name: Naushad Shaik, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Luke's Hospital, Kansas City, Missouri
name: Alan Wimmer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Trident Medical Center
name: Frank Cuoco, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Kansas Medical Center
name: Madhu Reddy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado, Denver
name: Ryan Aleong, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Spectrum Health System
name: Andre Gauri, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ohio State University
name: Raul Weiss, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oklahoma Heart
name: Craig Cameron, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Phoenix Cardiovascular Research Group
name: MArwan Bahu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Swedish Medical Center
name: Darryl Wells, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Med Center of the Rockies
name: Ethan Ellis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Policlinico Di San Donato Milanese
name: Carlo Pappone, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHI Baylor St. Lukes Medical Center
name: Abdi Rasekh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ruijin Hospital
name: Liqun Wu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sir Run Run Shaw Hospital
name: Chenyang Jiang, MD
role: PRINCIPAL_INVESTIGATOR
References: