ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT02799043
Previous Study | Return to List | Next Study

Randomized Evaluation of Redo Ablation Procedures of Atrial Fibrillation With Focal Impulse and Rotor Modulation 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02799043
Recruitment Status : Recruiting
First Posted : June 14, 2016
Last Update Posted : September 13, 2018
Sponsor:
Information provided by (Responsible Party):
Abbott Electrophysiology

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 268 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)
Study Start Date : June 2016
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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. ]
  2. Freedom from serious adverse events related to the procedure [ Time Frame: 10-day post treatment. ]
  3. Freedom from serious adverse events related to the procedure [ Time Frame: 12-month post treatment. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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


Contacts
Contact: Study Lead nirvi.mistry@abbott.com

  Show 30 Study Locations
Sponsors and Collaborators
Abbott Electrophysiology
Investigators
Principal Investigator: Vivek Reddy, MD MOUNT SINAI HOSPITAL
Principal Investigator: Stefan G. Spitzer, MD Praxisklinik Herz und Gefäße Dresden, Germany

Responsible Party: Abbott Electrophysiology
ClinicalTrials.gov Identifier: NCT02799043     History of Changes
Other Study ID Numbers: REDO-FIRM
First Posted: June 14, 2016    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Abbott Electrophysiology:
FIRMap, Rotor, FIRM-guided procedure

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes