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

Abbott Medical Devices51 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Paroxysmal Atrial Fibrillation

Interventions

FIRM-guided RF ablationPROCEDURE

Conventional RF ablationPROCEDURE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Universitäres Herzzentrum Lübeck

Lübeck, Germany

Outcomes

Primary Outcomes

Number of Participants With Single-procedure Freedom From AF/AT Recurrence From 3-12 Months Post Index Ablation Procedure

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.

Time frame: 3 -12 months post study treatment.

Secondary Outcomes

Number of Participants With Freedom From Procedure-related Serious Adverse Events

Freedom from procedure-related serious adverse events within one year of the index procedure

Time frame: Within 1 year post study treatment

Data from ClinicalTrials.gov

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