Focal Impulse and Rotor Modulation Ablation Trial for Treatment of Paroxysmal Atrial Fibrillation (FIRMAT-PAF) (FIRMAT-PAF)
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|ClinicalTrials.gov Identifier: NCT01925885|
Recruitment Status : Terminated (•Terminated: recruiting or enrolling participants has halted prematurely and will not resume; participants are no longer being examined or treated)
First Posted : August 20, 2013
Last Update Posted : April 5, 2017
- Hypothesis: Focal Impulse and Rotor Modulation (FIRM) will substantially reduce or eliminate clinical atrial fibrillation in subjects with accepted indications for catheter ablation of paroxysmal AF, compared to standard pulmonary vein isolation.
- Summary: This is a prospective randomized study to assess the safety and effectiveness of FIRM procedures only, versus standard Pulmonary Vein Isolation (PVI) procedures for the treatment of symptomatic paroxysmal atrial fibrillation.
|Condition or disease||Intervention/treatment||Phase|
|Paroxysmal Atrial Fibrillation||Procedure: PVI Ablation Procedure: FIRM Ablation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Focal Impulse and Rotor Modulation Ablation Trial for Treatment of Paroxysmal Atrial Fibrillation (FIRMAT-PAF)|
|Study Start Date :||September 2013|
|Actual Primary Completion Date :||December 23, 2015|
|Actual Study Completion Date :||December 23, 2015|
Active Comparator: PVI Ablation
Standard of care arm-pulmonary vein isolation (PVI)-involving moving the ablation catheter from point to point in a continuous line to surround the the orifices of the pulmonary veins in order to eliminate electrical conduction between the veins and left atrium.
Procedure: PVI Ablation
PVI ablation for atrial fibrillation specifically targets areas in the left atrium in the area just outside the pulmonary veins to eliminate triggers of atrial fibrillation.
Experimental: FIRM Ablation
FIRM ablation for paroxysmal atrial fibrillation at sites of rotors or focal impulse formation as designated by using the mapping algorithm of RhythmView
Procedure: FIRM Ablation
Ablation for atrial fibrillation specifically targets areas in the left or right atrium to eliminate areas that maintain atrial fibrillation without isolating the pulmonary veins
- Acute Ablation Success for Paroxysmal Atrial Fibrillation [ Time Frame: 1 week ]
- the termination of spontaneous or induced atrial fibrillation by ablation at an atrial fibrillation source arrhythmia location
- the slowing of the mean atrial fibrillation rate at least by 10% by ablation at an atrial fibrillation source arrhythmia
- evaluate safety and effectiveness of the FIRM procedures for the treatment of paroxysmal atrial fibrillation
- freedom from major adverse events related to the procedure within 7 days of the procedure
- Long Term Ablation Success for Paroxysmal Atrial Fibrillation [ Time Frame: 1 year ]
- freedom from atrial fibrillation recurrence (>30sec) from 3-12 months
- freedom from major adverse events related to the procedure within one year of the procedure
- Quality of Life [ Time Frame: 1 year ]EuroQOL Eq-5D scores pre-ablation will be compared to those post ablation at all points separately and together
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): NCT01925885
|United States, Indiana|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||John M Miller, MD||Indiana University|