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

• ClinicalTrials.gov Identifier: NCT02703454
• Recruitment Status: Terminated
• First Posted: March 9, 2016
• Results First Posted: May 21, 2019
• Last Update Posted: May 21, 2019
• Sponsor: Abbott Medical Devices
• Information provided by (Responsible Party): Abbott Medical Devices

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Paroxysmal Atrial Fibrillation	Procedure: FIRM-guided RF ablation; Procedure: Conventional RF ablation	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 51 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Focal Impulse and Rotor Modulation (FIRM) Ablation Versus Pulmonary Vein Isolation (PVI) for the Treatment of Paroxysmal Atrial Fibrillation (PAF)
• Study Start Date: February 2016
• Actual Primary Completion Date: February 2018
• Actual Study Completion Date: February 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: FIRM-only; Subjects in this arm will be treated with FIRM-guided RF ablation without pulmonary vein isolation (PVI).	Procedure: FIRM-guided RF ablation
Active Comparator: Conventional; Subjects in this arm will undergo conventional radio frequency (RF) ablation with confirmation of PVI.	Procedure: Conventional RF ablation

Outcome Measures

Primary Outcome Measures :

1. Number of Participants With Single-procedure Freedom From AF/AT Recurrence From 3-12 Months Post Index Ablation Procedure [ Time Frame: 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 :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Germany

Universitäres Herzzentrum Lübeck

Lübeck, Germany

Sponsors and Collaborators

Abbott Medical Devices

Investigators

• Principal Investigator: Roland R. Tilz, PD Dr. med.; Universität zu Lübeck
• Principal Investigator: Phillipp Sommer, PD Dr. med.; University of Leipzig

  Study Documents (Full-Text)

Documents provided by Abbott Medical Devices:

Study Protocol  [PDF] December 15, 2015

Statistical Analysis Plan  [PDF] January 5, 2016

More Information

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT02703454
• Other Study ID Numbers: CLN - 107
• First Posted: March 9, 2016
• Results First Posted: May 21, 2019
• Last Update Posted: May 21, 2019
• Last Verified: May 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

Additional relevant MeSH terms:

Atrial Fibrillation; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes