Clinical trial NCT05293639: Assessment of Safety and Effectiveness in Treatment Management of Atrial Fibrillation With the BWI IRE Ablation System
Official title: Assessment of Safety and Effectiveness in Treatment Management of Atrial Fibrillation With the BWI IRE Ablation System (AdmIRE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Interventional
Irreversible electroporation
Paroxysmal atrial fibrillation
Lead sponsor: Biosense Webster, Inc.
Sponsor class: INDUSTRY
First posted: 2022-03-24
Enrollment: 362
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: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pivotal Main Phase Modified Intent-To-Treat (mITT) Analysis Set: Number of Participants With Primary Adverse Events (PAEs)
timeFrame: From Day 0 to Day 7 post catheter insertion on Day 0
measure: Pilot Safety Analysis Set and Pivotal Roll-In Analysis Set: Number of Participants With Primary Adverse Events (PAEs)
timeFrame: From Day 0 to Day 7 post catheter insertion on Day 0
measure: Pivotal Main Phase Per-Protocol (PP) Analysis Set: Number of Participants With Freedom of Documented Atrial Tachyarrhythmia
timeFrame: Day 91 to Day 365 post catheter insertion on Day 0
measure: Pilot Safety Analysis Set and Pivotal Roll-In Analysis Set: Number of Participants With Freedom of Documented Atrial Tachyarrhythmia
timeFrame: Day 91 to Day 365 post catheter insertion on Day 0
Secondary outcomes:
measure: Pivotal Main Phase PP Analysis Set: Change From Baseline in Overall Atrial Fibrillation Effect on Quality-of-Life Questionnaire (AFEQT) Total Score
timeFrame: Baseline, and 12 months post catheter insertion on Day 0
measure: Pilot Safety Analysis Set and Pivotal Roll-In Analysis Set: Change From Baseline in Overall Atrial Fibrillation Effect on Quality-of-Life Questionnaire (AFEQT) Total Score
timeFrame: Baseline, and 12 months post catheter insertion on Day 0
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Grandview Medical Center
state: Alabama
city: Phoenix
country: United States
facility: Phoenix Cardiovascular Research
state: Arizona
city: Jonesboro
country: United States
facility: Arrhythmia Research Group (St. Bernards)
state: Arkansas
city: Larkspur
country: United States
facility: Cardiovascular Group of Marin/SF Med Group
state: California
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital
state: California
city: San Diego
country: United States
facility: San Diego Cardiac Center
state: California
city: Washington
country: United States
facility: Medstar Washington Hospital Center
state: District of Columbia
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Atlanta
country: United States
facility: Piedmont Healthcare
state: Georgia
city: Atlanta
country: United States
facility: Emory Saint Joseph's Hospital
state: Georgia
city: Savannah
country: United States
facility: Memorial Health University Medical Center
state: Georgia
city: Evanston
country: United States
facility: Evanston Hospital / Northshore
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute
state: Minnesota
city: Morristown
country: United States
facility: Morristown Medical Center
state: New Jersey
city: Bay Shore
country: United States
facility: South Shore University Hospital
state: New York
city: Bronx
country: United States
facility: Albert Einstein College of Medicine
state: New York
city: New York
country: United States
facility: New York University Langone Med Center
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital
state: New York
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Raleigh
country: United States
facility: Wakemed Heart and Vascular
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Philadelphia
country: United States
facility: Penn Presbyterian Medical Center
state: Pennsylvania
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Research Foundation
state: Texas
city: Plano
country: United States
facility: Baylor Research Institute
state: Texas
city: Falls Church
country: United States
facility: Inova Fairfax Medical Center
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth Uninversity
state: Virginia
Study officials:
affiliation: Biosense Webster, Inc.
name: Biosense Webster Inc. Clinical Trial
role: STUDY_DIRECTOR
References: