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

Abbott

Status: Terminated

Conditions: Paroxysmal Atrial Fibrillation

Treatments: Procedure: Conventional RF ablation; Procedure: FIRM-guided RF ablation

Study type: Interventional

Funder types: Industry

Identifiers

NCT02703454

CLN - 107

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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51 participants in 2 patient groups

FIRM-only

Experimental group

Description:

Subjects in this arm will be treated with FIRM-guided RF ablation without pulmonary vein isolation (PVI).

Treatment:

Procedure: FIRM-guided RF ablation

Conventional

Active Comparator group

Description:

Subjects in this arm will undergo conventional radio frequency (RF) ablation with confirmation of PVI.

Treatment:

Procedure: Conventional RF ablation