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

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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:
Information provided by (Responsible Party):
Abbott Medical Devices

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

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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

Resource links provided by the National Library of Medicine


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



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



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02703454


Locations
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Germany
Universitäres Herzzentrum Lübeck
Lübeck, Germany
Sponsors and Collaborators
Abbott Medical Devices
Investigators
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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


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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT02703454     History of Changes
Other Study ID Numbers: CLN - 107
First Posted: March 9, 2016    Key Record Dates
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:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes