Assessment of Safety and Effectiveness in Treatment Management of Atrial Fibrillation With the BWI IRE Ablation System

Atrial Fibrillation Clinical Trial

— AdmIRE  

Official title:

Assessment of Safety and Effectiveness in Treatment Management of Atrial Fibrillation With the BWI IRE Ablation System (AdmIRE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05293639
• Other study ID #: BWI201910
• Status: Completed
• Phase: N/A
• Start date: April 18, 2022
• Est. completion date: December 11, 2023

Study information

• Verified date: March 2024
• Source: Biosense Webster, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To demonstrate the safety and 12-month effectiveness of the VARIPULSE™ Catheter when used in conjunction with the TRUPULSE™ Generator for pulmonary vein isolation (PVI) in the treatment of subjects with symptomatic paroxysmal atrial fibrillation.

Description:

This is a prospective, non-randomized, multi-center, clinical evaluation of the Biosense Webster IRE Ablation system to demonstrate safety and long-term effectiveness for the treatment of drug refractory symptomatic PAF. The BWI IRE Ablation System consists of the VARIPULSE™ Catheter and TRUPULSE™ Generator. In conjunction with CARTO™ 3 system, it is indicated for PVI of patients with drug refractory paroxysmal atrial fibrillation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 362
• Est. completion date: December 11, 2023
• Est. primary completion date: December 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Key Inclusion Criteria:

• Diagnosed with Symptomatic Paroxysmal Atrial Fibrillation with

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.

Exclusion Criteria:

• Previously diagnosed with persistent AF (> 7 days in duration).

• AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.

• Previous surgical or catheter ablation for AF.

• Patients known to require ablation outside the PV region

• Documented severe dilatation of the LA (LAD >50mm) antero-posterior diameter on imaging within 6 months prior to enrollment.

• Documented LA thrombus by imaging within 48 hours of the procedure.

• Documented severely compromised LVEF (<40%) by imaging within 6 months prior to enrollment

• Uncontrolled heart failure or New York Heart Association Class III or IV

• History of blood clotting, bleeding abnormalities or contraindication to anticoagulation (heparin, warfarin, or dabigatran),

• Documented thromboembolic event (including TIA) within the past 12 months

• Previous PCI/MI within the past 2 months

• Coronary Artery Bypass Grafting (CABG) surgery within the past 6 months (180 days)

• Valvular cardiac surgical/percutaneous procedure

• Unstable angina within 6 months

• Anticipated cardiac transplantation, cardiac surgery, or other major surgery within the next 12 months.

• Significant pulmonary disease or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms.

• Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study

• Prior diagnosis of pulmonary vein stenosis

• Pre-existing hemi diaphragmatic paralysis

• Acute illness, active systemic infection, or sepsis

• Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation.

• Severe mitral regurgitation

• Presence of implanted pacemaker or Implantable Cardioverter-Defibrillator (ICD) or other implanted metal cardiac device that may interfere with the IRE energy field.

• Presence of a condition that precludes vascular access

• Current enrollment in an investigational study evaluating another device or drug.

• 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 less than 12 months

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• Pulse Field Ablation
PFA ablation using a circular multi-electrode pulsed electrical field catheter and multichannel generator

Locations

Country	Name	City	State
United States	Emory Saint Joseph's Hospital	Atlanta	Georgia
United States	Piedmont Healthcare	Atlanta	Georgia
United States	Texas Cardiac Arrhythmia Research Foundation	Austin	Texas
United States	Johns Hopkins	Baltimore	Maryland
United States	South Shore University Hospital	Bay Shore	New York
United States	Grandview Medical Center	Birmingham	Alabama
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Albert Einstein College of Medicine	Bronx	New York
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Evanston Hospital / Northshore	Evanston	Illinois
United States	Inova Fairfax Medical Center	Falls Church	Virginia
United States	Arrhythmia Research Group (St. Bernards)	Jonesboro	Arkansas
United States	Cardiovascular Group of Marin/SF Med Group	Larkspur	California
United States	Minneapolis Heart Institute	Minneapolis	Minnesota
United States	Morristown Medical Center	Morristown	New Jersey
United States	Mount Sinai School of Medicine	New York	New York
United States	New York Presbyterian Hospital	New York	New York
United States	New York University Langone Med Center	New York	New York
United States	Hoag Memorial Hospital	Newport Beach	California
United States	Florida Hospital	Orlando	Florida
United States	Penn Presbyterian Medical Center	Philadelphia	Pennsylvania
United States	Phoenix Cardiovascular Research	Phoenix	Arizona
United States	Baylor Research Institute	Plano	Texas
United States	Wakemed Heart and Vascular	Raleigh	North Carolina
United States	Virginia Commonwealth Uninversity	Richmond	Virginia
United States	San Diego Cardiac Center	San Diego	California
United States	Memorial Health University Medical Center	Savannah	Georgia
United States	Medstar Washington Hospital Center	Washington	District of Columbia
United States	Wake Forest Baptist Health	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Biosense Webster, Inc.

Country where clinical trial is conducted

United States, 

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 a circular multi-electrode Pulsed Electrical Field 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 (AFL).	3 - 12 months
Secondary	QOL Improvement	Atrial Fibrillation Effect on Quality-of-Life Questionnaire (AFEQT): defined as improvement in total score at 12M post procedure compared to baseline score.	12 months