Randomized Evaluation of Redo Ablation Procedures of Atrial Fibrillation With FIRM Guided Procedures (REDO-FIRM)

January 7, 2021 updated by: Abbott Medical Devices

Randomized Evaluation of Redo Ablation Procedures of Atrial Fibrillation With Focal Impulse and Rotor Modulation Guided Procedures (REDO-FIRM)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

269

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Flanders
      • Antwerp, Flanders, Belgium
        • University Hospital of Antwerp
  • Germany
      • Bad Oeynhausen, Germany
        • Ruhr University Bochum - Heart and Diabetes Center North Rhine-Westphalia
      • Berlin, Germany
        • UKB (Unfallkrankenhaus Berlin)
      • Dresden, Germany
        • Praxisklinik Herz und Gefässe Dresden
    • Bavaria
      • Coburg, Bavaria, Germany
        • Klinikum Coburg
      • Fürth, Bavaria, Germany
        • Furth Medical Clinic for Heart and Lung Diseases
      • Munich, Bavaria, Germany
        • The Dr. Müller Kliniken
    • Brandenburg
      • Potsdam, Brandenburg, Germany
        • Kardiologische Gemeinschaftspraxis am Park Sanssouci
    • Main
      • Frankfurt, Main, Germany
        • Kardiocentrum Frankfurt
    • Saxony
      • Leipzig, Saxony, Germany
        • Leipzig Heart Institute GmbH
    • Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, Germany
        • Luebeck University Heart Center
  • Netherlands
    • South Holland
      • Rotterdam, South Holland, Netherlands
        • Medical Center Rotterdam (Erasmus MC)
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Arizona Heart Rhythm Research Cente
    • California
      • Ventura, California, United States, 93003
        • Ventura Cardiology Consultants
    • Florida
      • Fort Lauderdale, Florida, United States, 33316
        • Broward Health
      • Jacksonville, Florida, United States, 32216
        • St. Vincent's HealthCare
    • Illinois
      • Chicago, Illinois, United States, 60153
        • Loyola University
      • Chicago, Illinois, United States, 60611
        • Northwestern University - Bluhm Cardiovascular Institute
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hospital
    • New Jersey
      • Englewood, New Jersey, United States, 07631
        • Englewood Hospital and Medical Center
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Health System
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • Virginia Heart

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
10-day 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
12-month post procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Investigators

  • Principal Investigator: Vivek Reddy, MD, Mount Sinai Hospital
  • Principal Investigator: Stefan G. Spitzer, MD, Praxisklinik Herz und Gefäße Dresden, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2016

Primary Completion (Actual)

July 1, 2020

Study Completion (Actual)

July 1, 2020

Study Registration Dates

First Submitted

June 2, 2016

First Submitted That Met QC Criteria

June 9, 2016

First Posted (Estimate)

June 14, 2016

Study Record Updates

Last Update Posted (Actual)

January 8, 2021

Last Update Submitted That Met QC Criteria

January 7, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REDO-FIRM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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