Randomized Evaluation of Redo Ablation Procedures of Atrial Fibrillation With FIRM Guided Procedures (REDO-FIRM)
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|ClinicalTrials.gov Identifier: NCT02799043|
Recruitment Status : Completed
First Posted : June 14, 2016
Last Update Posted : January 8, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Persistent Atrial Fibrillation Paroxysmal Atrial Fibrillation||Procedure: Standard PVI Procedure: FIRM-Guided Procedure and PVI||Not Applicable|
The hypothesis of this study was that Focal Impulse and Rotor Modulation (FIRM) guided procedures will eliminate the source of clinical arrhythmias in subjects with clinical indications for repeat AF ablation procedures.
This study is a prospective, multicenter, randomized, controlled study to assess the safety and effectiveness of FIRM procedures followed by ablation including pulmonary vein isolation versus a standard conventional procedure including pulmonary vein isolation for the redo-treatment of persistent or paroxysmal atrial fibrillation after one failed previous pulmonary vein isolation.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||269 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Evaluation of Redo Ablation Procedures of Atrial Fibrillation With Focal Impulse and Rotor Modulation Guided Procedures (REDO-FIRM)|
|Actual Study Start Date :||June 2016|
|Actual Primary Completion Date :||July 2020|
|Actual Study Completion Date :||July 2020|
Active Comparator: Standard PVI
Standard catheter ablation including pulmonary vein isolation (PVI) procedure.
Procedure: Standard PVI
Standard PVI procedure without FIRMap.
Experimental: FIRM-guided Procedure and PVI
FIRM-guided procedure followed by PVI.
Procedure: FIRM-Guided Procedure and PVI
- Freedom from atrial fibrillation atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) recurrence at 12 months post procedure. [ Time Frame: 12 months post procedure ]Single procedure freedom from recurrence from 3-12 months post procedure
- Freedom from serious adverse events related to the procedure [ Time Frame: 10-day post procedure ]Freedom from any procedure-related serious adverse event from 0-10 days post procedure
- Freedom from serious adverse events related to the procedure [ Time Frame: 12-month post procedure ]Freedom from any procedure-related serious adverse event from 0-12 months post 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|
- Experiencing at least one (1) documented episode of spontaneous persistent or paroxysmal atrial fibrillation during the last 3 months by rhythm strip/ECG.
- One (1) previous AF ablation (PVI-only - any technology) after Jan-01-2013, but NOT within the last 3 months.
- Left atrial diameter < 6.0 cm via transthoracic echo or transesophageal echo; or <6.5 cm via CT or MRI with 6 months prior to the procedure.
- Sustained spontaneous or induced AF (>5 min uninterrupted).
- Presence of structural heart disease with clinical significance
- NYHA Class IV
- Ejection fraction < 35%
- Previous AF ablation within the last 3 months
- ASD closure device, LAA closure device, prosthetic mitral or tricuspid valve, or permanent pacemaker.
- History of myocardial infarction (MI) within the past three (3) months
- Atrial clot/thrombus noted within 72 hours of the 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): NCT02799043
|Principal Investigator:||Vivek Reddy, MD||MOUNT SINAI HOSPITAL|
|Principal Investigator:||Stefan G. Spitzer, MD||Praxisklinik Herz und Gefäße Dresden, Germany|
|Responsible Party:||Abbott Medical Devices|
|Other Study ID Numbers:||
|First Posted:||June 14, 2016 Key Record Dates|
|Last Update Posted:||January 8, 2021|
|Last Verified:||January 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
FIRMap, Rotor, FIRM-guided procedure