Clinical trial NCT02703454: FIRM Ablation Versus Pulmonary Vein Isolation for the Treatment of Paroxysmal Atrial Fibrillation (PAF)
Official title: Focal Impulse and Rotor Modulation (FIRM) Ablation Versus Pulmonary Vein Isolation (PVI) for the Treatment of Paroxysmal Atrial Fibrillation (PAF)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Paroxysmal Atrial Fibrillation
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2016-03-09
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Number of Participants With Single-procedure Freedom From AF/AT Recurrence From 3-12 Months Post Index Ablation Procedure
timeFrame: 3 -12 months post study treatment.
Secondary outcomes:
measure: Number of Participants With Freedom From Procedure-related Serious Adverse Events
timeFrame: Within 1 year post study treatment
Other outcomes:
Locations:
city: Lübeck
country: Germany
facility: Universitäres Herzzentrum Lübeck
Study officials:
affiliation: Universität zu Lübeck
name: Roland R. Tilz, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Leipzig
name: Phillipp Sommer, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: