A Study of VARIPULSE Pulsed Field Ablation (PFA) Catheter and FARAWAVE PFA Catheter in the Treatment of Participants With Persistent Atrial Fibrillation

Official title

Comparison of Safety and Effectiveness of a VARIPULSE™ PFA Catheter to FARAWAVE™ PFA Catheter in the Treatment of Participants With Persistent Atrial Fibrillation: A Randomized Controlled Trial

Overview

The purpose of this study is to assess how safe VARIPULSE pulsed field ablation (PFA) catheter is and how well it works compared to food and drug administration (FDA) approved FARAWAVE PFA catheter in participants with symptomatic persistent atrial fibrillation (PsAF; continuous irregular, rapid heartbeat that lasts over 7 days and doesn't stop on its own).

Interventions

• Device VARIPULSE Catheter
  Pulsed Field Ablation using the VARIPULSE catheter.
• Device FARAWAVE Catheter
  Pulsed field ablation using the FARAWAVE catheter.

Primary outcome measures

• Occurrence of Early Onset Primary Adverse Events (PAEs) [Time frame: Up to 7 days post-index procedure]
• Time to Occurrence of Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmia Episodes [Time frame: Day 61 and onward]

Secondary outcome measures (1)

• Change From Baseline in Quality of life, As Measured by the Total Atrial Fibrillation Effect on Quality-of-Life (AFEQT) Score [Time frame: Baseline and at 6 months post procedure]

Eligibility criteria

Inclusion criteria

• Participant has been diagnosed with symptomatic persistent atrial fibrillation (PsAF), which is defined as continuous atrial fibrillation (AF) sustained beyond 7 days and less than 365 days in duration documented by: i. A physician's note documenting diagnosis of symptomatic PsAF as defined above and ii. Two electrocardiograms showing continuous AF, with electrocardiogram taken at least 7 days apart (electrocardiograms cannot be greater than \[>\] 365 days prior to enrollment) or iii. A 24-hour arrhythmia monitor documenting continuous AF within the last 365 days
• Participant is aged 18 - 80 years at the time of informed consent
• Participant is willing and capable of providing informed consent
• Participant is able and willing to comply with all pre-, post- and follow-up testing and requirements

Exclusion criteria

• Participant has continuous AF > 365 days (longstanding persistent AF)
• Participant has AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (for example, untreated documented obstructive sleep apnea, acute alcohol toxicity, etc.)
• Participant has had previous surgical or catheter ablation for AF
• Participant is known to require ablation outside the left atrium (LA), superior vena cava (SVC), and the cavotricuspid isthmus (CTI) region (for example, atrioventricular reentrant tachycardia, atrioventricular nodal reentry tachycardia, ventricular tachycardia and Wolff-Parkinson-White)
• Participant has severe dilatation of the LA (LAD > 50 millimeters \[mm\]) of the antero-posterior diameter confirmed by imaging performed within 180 days prior to enrollment
• Participant has LA thrombus confirmed by imaging within 48 hours prior to the procedure
• Participant has severely compromised Left Ventricular Ejection Fraction (LVEF less than \[<\] 40%) confirmed by imaging performed within 180 days prior to enrollment
• Participant has uncontrolled heart failure or New York Heart Association (NYHA) Class III or IV
• Participant has a history of blood clotting, bleeding abnormalities or contraindication to anticoagulation (for example, heparin)
• Participant has had a thromboembolic event (including TIA) within the past 180 days prior to enrollment
• Participant has had a percutaneous coronary intervention or acute MI within past 60 days prior to enrollment
• Participant has had coronary artery bypass grafting (CABG) surgery within the past 180 days prior to enrollment
• Participant has had valvular cardiac surgical/percutaneous procedure (that is, ventriculotomy, atriotomy, valve repair or replacement and presence of a prosthetic valve)
• Participant has unstable angina within past 6 months prior to enrollment
• Participant has anticipated cardiac transplantation, cardiac surgery, or other major surgery within the next 365 days post-procedure
• Participant has significant pulmonary disease (for example, restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms
• Participant has a significant congenital anomaly (for example, atrial septal defects \[ASDs\]) including repaired defects or medical problems that in the opinion of the Investigator would preclude enrollment in this study
• Participant has an existing diagnosis of pulmonary vein stenosis (PVS)
• Participant has a pre-existing hemi-diaphragmatic paralysis
• Participant has an acute illness, active systemic infection, or sepsis
• Participant has an intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation
• Participant has severe mitral regurgitation (regurgitant volume greater than or equal to \[>=\] 60 milliliters \[mL\]/beat, regurgitant fraction >= 50 percent \[%\], and/or effective regurgitant orifice area >= 0.40 square centimeter \[cm\^2\])
• Participant has an implanted metal cardiac device, including MitraClip and left atrial appendage occlusion (LAAO) devices (for example, WATCHMAN, Amulet, etcetra.) and/or a double-coiled implantable cardioverter-defibrillators (ICD), (this exclusion does not include coronary stents, implanted pacemakers, single-coiled ICD and implantable loop recorders \[ILR\])
• Participant has a condition that precludes vascular access (such as inferior vena cava \[IVC\] filter)
• Participant is currently enrolled in an investigational study evaluating another device or drug
• Participant is pregnant, lactating, or is of child-bearing potential and plans on trying to become pregnant during the course of the clinical investigation
• Participant has a life expectancy less than 365 days

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 30 centers

• Arizona Arrhythmia Research Center — Phoenix
• Arrhythmia Research Group — Jonesboro
• OC Medical Center — Fountain Valley
• Stanford University Medical Center — Stanford
• Community Memorial Hospital — Ventura
• St. Vincents Medical Center — Jacksonville
• HCA Florida Mercy Hospital — Miami
• NCH Healthcare — Naples
• … and 22 more centers

Identifiers

NCT: NCT07523750 · BWI202516

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗