FIRM Ablation Versus Pulmonary Vein Isolation for the Treatment of Paroxysmal Atrial Fibrillation (PAF)

Not Applicable

Terminated

Interventions: Procedure: Conventional RF ablation
Procedure: FIRM-guided RF ablation

Brief Summary: The study is designed as a prospective, multicenter, single-blind, randomized study to assess the safety and effectiveness of FIRM-guided radiofrequency (RF) ablation procedures for the treatment of symptomatic paroxysmal atrial fibrillation (PAF). The subjects will be blinded to study treatment for the duration of the study period.

Recruitment & Eligibility

Inclusion Criteria

Experiencing at least two (2) documented episodes of paroxysmal atrial fibrillation in the last 3 months preceding study entry with clinical indication for atrial fibrillation (AF) ablation per guidelines. At least one episode should be documented by rhythm strip or ECG.
Indicated for AF ablation according to current European Heart Rhythm Association (EHRA) guidelines.
Prescribed with oral anticoagulation therapy, in indicated patients per the latest EHRA guidelines.
Willingness and able to remain on anti-coagulation therapy as per the latest EHRA guidelines.
Left atrial diameter < 5.5 cm as measured and image ((computed tomography (CT)/ transesophageal echocardiogram (TEE)/ transthoracic echocardiogram (TTE)/ magnetic resonance imaging (MRI) or intracardiac echocardiography (ICE)) documented within previous six months up to pre-procedure.
Sustained AF (>5 min uninterrupted) during the electrophysiology procedure. If the subject is not experiencing spontaneous, sustained AF, it may be induced by burst pacing (typically from the coronary sinus) with or without isoproterenol infusion in conventional clinical fashion.

Key

Exclusion Criteria

New York Heart Association heart failure (NYHA) Class III - IV.
Ejection fraction < 40% (within previous six months).
History of myocardial infarction (MI) within the past three months.
Any concomitant arrhythmia or therapy that could interfere with the interpretation of the results from this study.
Atrial septal defect (ASD) closure device, left atrial appendage (LAA) closure device, prosthetic mitral or tricuspid valve, or permanent pacemaker.
Any previous AF catheter ablation.
History of prior cardioversion for AF lasting > 48 hours.
Continuous AF episode lasting > 7 days immediately prior to the procedure without a sinus rhythm.

Arm && Interventions

Group	Intervention	Description
Conventional	Conventional RF ablation	Subjects in this arm will undergo conventional radio frequency (RF) ablation with confirmation of PVI.
FIRM-only	FIRM-guided RF ablation	Subjects in this arm will be treated with FIRM-guided RF ablation without pulmonary vein isolation (PVI).

Primary Outcome Measures

Name	Time	Method
Number of Participants With Single-procedure Freedom From AF/AT Recurrence From 3-12 Months Post Index Ablation Procedure	3 -12 months post study treatment.	Freedom from AF/AT recurrence is defined as no documented episodes of AF/AT \> 30 seconds with conventional non-invasive monitoring. In the case of a cardiac implanted electronic device (CIED), freedom from AF recurrence is defined as no documented episodes of AF/AT \> 30 seconds in a 72-hour window at the follow-up visits in addition to any symptomatic episodes with documented AF \> 30 seconds. AT recurrence does not include episodes of cavotricuspid isthmus (CTI) dependent flutter.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Freedom From Procedure-related Serious Adverse Events	Within 1 year post study treatment	Freedom from procedure-related serious adverse events within one year of the index procedure