Sarasota Memorial Hospital | Clinical Research Center
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The purpose of this study is to establish the safety and effectiveness of pulsed field ablation as a first-line ablation treatment for subjects with persistent atrial fibrillation as compared to subjects who received an initial treatment with anti-arrhythmic drugs.
Full description
This is a prospective, randomized, multi-center, global, pivotal Investigational device exemption (IDE) study. Subjects with persistent atrial fibrillation will be randomized or assigned to either pulsed field ablation (PFA) or Versus Anti-Arrhythmic Drug (AAD) treatment.
Once randomization is complete, additional subjects will be enrolled and sequentially assigned to receive PFA treatment to fulfill the number of subjects required for the Primary Safety Endpoint assessment. These additional subjects are referred to as PFA Assigned (Non-Roll-In) Subjects.
Subjects randomized or assigned to PFA treatment will undergo percutaneous ablative pulmonary vein isolation (PVI) and left atrial posterior wall isolation (PWI) using the FARAWAVE™ PFA Catheter (first-line ablation cohort).
Subjects randomized to AAD treatment will be prescribed and monitored in accordance with local clinical practice and already established guideline-directed therapy for patients with persistent atrial fibrillation (AF). In the case of clinical inefficacy, the AAD dose will be up-titrated to the maximum tolerated dose. Thereafter, a change to a second or to a third AAD should be undertaken, insofar as the subject remains within the blanking period, with the goal to completely suppress AF episodes ≥ 30 seconds in duration. If AAD treatment is proven to be ineffective or intolerable outside of the blanking period, subjects can undergo subsequent ablation therapy and be considered part of the "delayed ablation cohort".
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Inclusion criteria
a. Documentation, within 180 days of randomization, or treatment assignment for roll-in subjects, of either:
i. A 24-hour continuous ECG recording (from any regulatory cleared rhythm monitoring device) confirming continuous AF, OR
ii. Two ECGs (from any regulatory cleared rhythm monitoring device) showing continuous AF taken at least 7 days apart b. Documentation, such as physician note, of persistent continuous AF for > 7 days and ≤ 365 days
Exclusion criteria
a. More than 7-day history of therapeutic AAD use (Class I or III), orb. ≥ 24 hours amiodarone, i Note Pill-in-the-pocket AAD use, is permitted. 2. Treated with AAD ( Class I or III) > 6 months (i.e., more than 180 days) before enrollment and experienced AAD failure (adverse drug effects or frequent AF episodes) 3. Contraindication to, or unwillingness to use, AADs (Class I and III, excluding amiodarone) 4. Contraindication to PFA treatment 5. Contraindication to, or unwillingness to use, systemic anticoagulation, or acceptable alternatives, pre-, intra-, and post-procedure to achieve adequate anticoagulation.
Any of the following cardiovascular conditions:
History of sustained ventricular tachycardia or any ventricular fibrillation
AF that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible / non-cardiac causes
Current or anticipated pacemaker, implantable cardioverter defibrillator or cardiac resynchronization therapy devices, interatrial baffle, atrial septal patch, atrial septal defect closure device, or patent foramen ovale occluder
Valvular disease that is any of the following: i. Symptomatic, ii. Causing or exacerbating congestive heart failure, iii. Associated with abnormal left ventricular (LV) function or hemodynamic measurements
Hypertrophic cardiomyopathy
Cardiac amyloidosis
Any prosthetic heart valve, ring or repair including balloon aortic valvuloplasty
Any inferior vena cava (IVC) filter, known inability to obtain vascular access or other contraindication to femoral access
Rheumatic heart disease
Congenital heart disease with any clinically significant residual anatomic or conduction abnormality
Awaiting cardiac transplantation or other cardiac surgery within the next 12 months
Any of the following conditions identified during screening assessments
Heart failure associated with New York Heart Association (NYHA) Class IV
Left Ventricle Ejection Fraction (LVEF) < 40%
Uncontrolled hypertension (Systolic Blood Pressure > 160 mmHg or Diastolic Blood Pressure > 95 mmHg on two (2) BP measurements during screening
Any of the following events 90 days prior to randomization (or Index procedure for PFA Assigned or roll-in subjects):
Myocardial infarction (MI), unstable angina or coronary intervention
Cardiac surgery
Heart failure hospitalization
Pericarditis or symptomatic pericardial effusion
Gastrointestinal bleeding
Stroke, TIA, or intracranial bleeding
Non-neurologic thromboembolic event
Carotid stenting or endarterectomy
10.Known coagulopathy disorder (e.g., von Willbrand's disease, hemophilia)
Primary purpose
Allocation
Interventional model
Masking
520 participants in 2 patient groups
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Central trial contact
Boston Scientific; Boston Scientific
Data sourced from clinicaltrials.gov
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