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
|Condition or disease||Intervention/treatment||Phase|
|Paroxysmal Atrial Fibrillation||Procedure: FIRM-guided RF ablation Procedure: Conventional RF ablation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||51 participants|
|Intervention Model:||Parallel Assignment|
|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|
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
- 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.
- 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
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
|Universitäres Herzzentrum Lübeck|
|Principal Investigator:||Roland R. Tilz, PD Dr. med.||Universität zu Lübeck|
|Principal Investigator:||Phillipp Sommer, PD Dr. med.||University of Leipzig|