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Trial record 1 of 1 for:    NCT02799043
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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
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Study Description
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Brief Summary:
A prospective, multicenter, randomized study to assess the safety and effectiveness of FIRM-guided procedures in conventional "redo" RF ablation procedures for the treatment of persistent and paroxysmal atrial fibrillation.

Condition or disease Intervention/treatment Phase
Persistent Atrial Fibrillation Paroxysmal Atrial Fibrillation Procedure: Standard PVI Procedure: FIRM-Guided Procedure and PVI Not Applicable

Detailed Description:

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 269 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Standard PVI
Standard catheter ablation including pulmonary vein isolation (PVI) procedure.
 Procedure: Standard PVI
Standard PVI procedure without FIRMap.
Other Names:
  • Pulmonary vein isolation
  • Ablation
  • Arrhythmia
  • Atrial fibrillation Mapping
Experimental: FIRM-guided Procedure and PVI
FIRM-guided procedure followed by PVI.
 Procedure: FIRM-Guided Procedure and PVI
Other Names:
  • Pulmonary vein isolation
  • Atrial fibrillation Mapping
  • FIRMap


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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

  3. 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


Eligibility Criteria
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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
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Principal Investigator: Vivek Reddy, MD MOUNT SINAI HOSPITAL
Principal Investigator: Stefan G. Spitzer, MD Praxisklinik Herz und Gefäße Dresden, Germany
More Information
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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT02799043    
Other Study ID Numbers: REDO-FIRM
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
Keywords provided by Abbott Medical Devices:
FIRMap, Rotor, FIRM-guided procedure
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes