Randomized Evaluation of Redo Ablation Procedures of Atrial Fibrillation With FIRM Guided Procedures (REDO-FIRM)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02799043|
Recruitment Status : Active, not recruiting
First Posted : June 14, 2016
Last Update Posted : July 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|Persistent Atrial Fibrillation Paroxysmal Atrial Fibrillation||Procedure: Standard PVI Procedure: FIRM-Guided Procedure and PVI||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||268 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)|
|Study Start Date :||June 2016|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||December 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 3 -12 months post procedure. [ Time Frame: 3-12 months post treatment. ]
- Freedom from serious adverse events related to the procedure [ Time Frame: 10-day post treatment. ]
- Freedom from serious adverse events related to the procedure [ Time Frame: 12-month post treatment. ]
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|