Assessment of Safety and Effectiveness in Treatment Management of Atrial Fibrillation With the BWI IRE Ablation System
- Conditions
- Atrial Fibrillation
- Interventions
- Device: Pulse Field Ablation
- Registration Number
- NCT05293639
- Lead Sponsor
- Biosense Webster, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 362
-
Diagnosed with Symptomatic Paroxysmal Atrial Fibrillation with
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment Group Pulse Field Ablation PFA ablation using a circular multi-electrode pulsed electrical field catheter and multichannel generator
- Primary Outcome Measures
Name Time Method Pivotal Main Phase Per-Protocol (PP) Analysis Set: Number of Participants With Freedom of Documented Atrial Tachyarrhythmia Day 91 to Day 365 post catheter insertion on Day 0 Number of Participants With freedom from documented (symptomatic and asymptomatic) atrial tachyarrhythmia (atrial fibrillation \[AF\], atrial tachycardia \[AT\], or atrial flutter \[AFL\] of unknown origin positive) episodes based on electrocardiographic data (greater than or equal to \[\>=\] 30 seconds on an electrocardiogram \[ECG\], sponsor-provided cardiac event monitor \[CEM\], or Holter device) during the effectiveness evaluation period (Day 91-365 post catheter insertion procedure) and freedom from the following failure modes: acute procedural failure, repeat ablation failure, non-study catheter failure, AAD failure, continuous AF/AT/AFL of unknown origin on ECG, any Direct Current Cardioversion (DCCV) procedure were reported.
Pilot Safety Analysis Set and Pivotal Roll-In Analysis Set: Number of Participants With Primary Adverse Events (PAEs) From Day 0 to Day 7 post catheter insertion on Day 0 An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. PAEs included the following AEs: Phrenic Nerve Paralysis (permanent), Stroke/CVA, Major Vascular Access Complication/Bleeding, Thromboembolism, Myocardial Infarction, Transient Ischemic Attack (TIA), Pericarditis, Pulmonary Edema (Respiratory Insufficiency), Heart Block, and Vagal Nerve Injury/ Gastroparesis.
Pivotal Main Phase Modified Intent-To-Treat (mITT) Analysis Set: Number of Participants With Primary Adverse Events (PAEs) From Day 0 to Day 7 post catheter insertion on Day 0 An adverse event (AE) was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. PAEs included the following AEs: Phrenic Nerve Paralysis (permanent), Stroke/Cerebrovascular accident (CVA), Major Vascular Access Complication/Bleeding, Thromboembolism, Myocardial Infarction, Transient Ischemic Attack (TIA), Pericarditis, Pulmonary Edema (Respiratory Insufficiency), Heart Block, and Vagal Nerve Injury/ Gastroparesis.
Pilot Safety Analysis Set and Pivotal Roll-In Analysis Set: Number of Participants With Freedom of Documented Atrial Tachyarrhythmia Day 91 to Day 365 post catheter insertion on Day 0 Number of Participants With freedom from documented (symptomatic and asymptomatic) atrial tachyarrhythmia (AF, AT, or AFL of unknown origin positive) episodes based on electrocardiographic data (\>=30 seconds on an ECG, CEM, or Holter device) during the effectiveness evaluation period (Day 91-365 post catheter insertion) and freedom from the following failure modes: acute procedural failure, repeat ablation failure, non-study catheter failure, AAD failure, continuous AF/AT/AFL of unknown origin on ECG, any DCCV procedure were reported.
- Secondary Outcome Measures
Name Time Method 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 Baseline, and 12 months post catheter insertion on Day 0 Change from baseline in overall AFEQT total score were reported. Change in the AFEQT score included 20 questions on a 7-point Likert scale. Questions 1-18 evaluated HRQoL and questions 19-20 were related to the patient's satisfaction with treatment. The first 18 questions were used to calculate the overall AFEQT score. The total AFEQT scores was calculated as 100 minus (\[Sum of severity for all questions answered minus number of questions answered) divided by total number of questions answered\*6\])\*100. The overall AFEQT scores ranged from 0 (complete disability) to 100 (no disability). Therefore, a positive change in score corresponded to improvement in QoL.
Pivotal Main Phase PP Analysis Set: Change From Baseline in Overall Atrial Fibrillation Effect on Quality-of-Life Questionnaire (AFEQT) Total Score Baseline, and 12 months post catheter insertion on Day 0 Change from baseline in overall AFEQT total score were reported. Change in the AFEQT score included 20 questions on a 7-point Likert scale. Questions 1-18 evaluated Health Related Quality of Life (HRQoL) and questions 19-20 were related to the patient's satisfaction with treatment. The first 18 questions were used to calculate the overall AFEQT score. The total AFEQT scores was calculated as 100 minus (\[Sum of severity for all questions answered minus number of questions answered) divided by total number of questions answered\*6\])\*100. The overall AFEQT scores ranged from 0 (complete disability) to 100 (no disability). Therefore, a positive change in score corresponded to improvement in QoL.
Trial Locations
- Locations (30)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Johns Hopkins
🇺🇸Baltimore, Maryland, United States
Morristown Medical Center
🇺🇸Morristown, New Jersey, United States
Piedmont Healthcare
🇺🇸Atlanta, Georgia, United States
Memorial Health University Medical Center
🇺🇸Savannah, Georgia, United States
Arrhythmia Research Group (St. Bernards)
🇺🇸Jonesboro, Arkansas, United States
Cardiovascular Group of Marin/SF Med Group
🇺🇸Larkspur, California, United States
Hoag Memorial Hospital
🇺🇸Newport Beach, California, United States
Medstar Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Emory Saint Joseph's Hospital
🇺🇸Atlanta, Georgia, United States
Evanston Hospital / Northshore
🇺🇸Evanston, Illinois, United States
Albert Einstein College of Medicine
🇺🇸Bronx, New York, United States
South Shore University Hospital
🇺🇸Bay Shore, New York, United States
New York University Langone Med Center
🇺🇸New York, New York, United States
New York Presbyterian Hospital
🇺🇸New York, New York, United States
Mount Sinai School of Medicine
🇺🇸New York, New York, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Wakemed Heart and Vascular
🇺🇸Raleigh, North Carolina, United States
Penn Presbyterian Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
Baylor Research Institute
🇺🇸Plano, Texas, United States
Inova Fairfax Medical Center
🇺🇸Falls Church, Virginia, United States
Wake Forest Baptist Health
🇺🇸Winston-Salem, North Carolina, United States
Grandview Medical Center
🇺🇸Birmingham, Alabama, United States
Phoenix Cardiovascular Research
🇺🇸Phoenix, Arizona, United States
San Diego Cardiac Center
🇺🇸San Diego, California, United States
Florida Hospital
🇺🇸Orlando, Florida, United States
Minneapolis Heart Institute
🇺🇸Minneapolis, Minnesota, United States
Texas Cardiac Arrhythmia Research Foundation
🇺🇸Austin, Texas, United States
Virginia Commonwealth Uninversity
🇺🇸Richmond, Virginia, United States