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

Focal Impulse and Rotor Modulation (FIRM) Ablation Versus Pulmonary Vein Isolation (PVI) for the Treatment of Paroxysmal Atrial Fibrillation (PAF)

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 Overview

• Status: Terminated
• Conditions: Paroxysmal Atrial Fibrillation
• Intervention / Treatment: Procedure: FIRM-guided RF ablation; Procedure: Conventional RF ablation

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Lübeck, Germany
    • Universitäres Herzzentrum Lübeck

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 -12 months post study treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Within 1 year post study treatment

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): February 1, 2018
• Study Completion (Actual): February 1, 2018

Study Registration Dates

• First Submitted: March 4, 2016
• First Submitted That Met QC Criteria: March 4, 2016
• First Posted (Estimate): March 9, 2016

Study Record Updates

• Last Update Posted (Actual): May 21, 2019
• Last Update Submitted That Met QC Criteria: May 20, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: CLN - 107

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED