FIRM Ablation Versus Pulmonary Vein Isolation for the Treatment of Paroxysmal Atrial Fibrillation (PAF)
NCT ID: NCT02703454
Last Updated: 2019-05-21
Study Results
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View full resultsBasic Information
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TERMINATED
NA
51 participants
INTERVENTIONAL
2016-02-29
2018-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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FIRM-only
Subjects in this arm will be treated with FIRM-guided RF ablation without pulmonary vein isolation (PVI).
FIRM-guided RF ablation
Conventional
Subjects in this arm will undergo conventional radio frequency (RF) ablation with confirmation of PVI.
Conventional RF ablation
Interventions
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FIRM-guided RF ablation
Conventional RF ablation
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Roland R. Tilz, PD Dr. med.
Role: PRINCIPAL_INVESTIGATOR
Universität zu Lübeck
Phillipp Sommer, PD Dr. med.
Role: PRINCIPAL_INVESTIGATOR
University of Leipzig
Locations
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Universitäres Herzzentrum Lübeck
Lübeck, , Germany
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CLN - 107
Identifier Type: -
Identifier Source: org_study_id
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