Randomized Evaluation of Redo Ablation Procedures of Atrial Fibrillation With FIRM Guided Procedures
REDO-FIRM
1 other identifier
interventional
269
4 countries
24
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2016
Longer than P75 for not_applicable
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 2, 2016
CompletedFirst Posted
Study publicly available on registry
June 14, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2020
CompletedResults Posted
Study results publicly available
September 19, 2024
CompletedSeptember 19, 2024
September 1, 2024
4.1 years
June 2, 2016
April 8, 2024
September 5, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Freedom From Atrial Fibrillation Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Recurrence at 12 Months Post Procedure.
Single procedure freedom from recurrence from 3-12 months post procedure
12 months post procedure
Freedom From Serious Adverse Events Related to the Procedure
Freedom from any procedure-related serious adverse event from 0-10 days post procedure
10-day post procedure
Freedom From Serious Adverse Events Related to the Procedure
Freedom from any procedure-related serious adverse event from 0-12 months post procedure
12-month post procedure
Study Arms (2)
Standard PVI
ACTIVE COMPARATORStandard catheter ablation including pulmonary vein isolation (PVI) procedure.
FIRM-guided Procedure and PVI
EXPERIMENTALFIRM-guided procedure followed by PVI.
Interventions
Standard PVI procedure without FIRMap.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Arizona Heart Rhythm Research Cente
Phoenix, Arizona, 85016, United States
Ventura Cardiology Consultants
Ventura, California, 93003, United States
Broward Health
Fort Lauderdale, Florida, 33316, United States
St. Vincent's HealthCare
Jacksonville, Florida, 32216, United States
Loyola University
Chicago, Illinois, 60153, United States
Northwestern University - Bluhm Cardiovascular Institute
Chicago, Illinois, 60611, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Englewood Hospital and Medical Center
Englewood, New Jersey, 07631, United States
Ohio State University
Columbus, Ohio, 43210, United States
University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Virginia Heart
Falls Church, Virginia, 22042, United States
University Hospital of Antwerp
Antwerp, Flanders, Belgium
Klinikum Coburg
Coburg, Bavaria, Germany
Furth Medical Clinic for Heart and Lung Diseases
Fürth, Bavaria, Germany
The Dr. Müller Kliniken
Munich, Bavaria, Germany
Kardiologische Gemeinschaftspraxis am Park Sanssouci
Potsdam, Brandenburg, Germany
Kardiocentrum Frankfurt
Frankfurt, Main, Germany
Leipzig Heart Institute GmbH
Leipzig, Saxony, Germany
Luebeck University Heart Center
Lübeck, Schleswig-Holstein, Germany
Ruhr University Bochum - Heart and Diabetes Center North Rhine-Westphalia
Bad Oeynhausen, Germany
UKB (Unfallkrankenhaus Berlin)
Berlin, Germany
Praxisklinik Herz und Gefäße Dresden
Dresden, Germany
Medical Center Rotterdam (Erasmus MC)
Rotterdam, South Holland, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Anne Sarver, PhD
- Organization
- Abbott
Study Officials
- PRINCIPAL INVESTIGATOR
Vivek Reddy, MD
MOUNT SINAI HOSPITAL
- PRINCIPAL INVESTIGATOR
Stefan G. Spitzer, MD
Praxisklinik Herz und Gefäße Dresden, Germany
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2016
First Posted
June 14, 2016
Study Start
June 1, 2016
Primary Completion
July 1, 2020
Study Completion
July 1, 2020
Last Updated
September 19, 2024
Results First Posted
September 19, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will not share