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

Primary Purpose

Persistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Standard PVI
FIRM-Guided Procedure and PVI
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Persistent Atrial Fibrillation focused on measuring FIRMap, Rotor, FIRM-guided procedure

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Arizona Heart Rhythm Research Cente
  • Ventura Cardiology Consultants
  • Broward Health
  • St. Vincent's HealthCare
  • Loyola University
  • Northwestern University - Bluhm Cardiovascular Institute
  • Johns Hopkins Hospital
  • Englewood Hospital and Medical Center
  • Ohio State University
  • University of Pennsylvania Health System
  • University of Pittsburgh Medical Center
  • Virginia Heart
  • University Hospital of Antwerp
  • Klinikum Coburg
  • Furth Medical Clinic for Heart and Lung Diseases
  • The Dr. Müller Kliniken
  • Kardiologische Gemeinschaftspraxis am Park Sanssouci
  • Kardiocentrum Frankfurt
  • Leipzig Heart Institute GmbH
  • Luebeck University Heart Center
  • Ruhr University Bochum - Heart and Diabetes Center North Rhine-Westphalia
  • UKB (Unfallkrankenhaus Berlin)
  • Praxisklinik Herz und Gefäße Dresden
  • Medical Center Rotterdam (Erasmus MC)

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard PVI

FIRM-guided Procedure and PVI

Arm Description

Standard catheter ablation including pulmonary vein isolation (PVI) procedure.

FIRM-guided procedure followed by PVI.

Outcomes

Primary Outcome Measures

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
Freedom from serious adverse events related to the procedure
Freedom from any procedure-related serious adverse event from 0-10 days 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

Secondary Outcome Measures

Full Information

First Posted
June 2, 2016
Last Updated
January 7, 2021
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT02799043
Brief Title
Randomized Evaluation of Redo Ablation Procedures of Atrial Fibrillation With FIRM Guided Procedures
Acronym
REDO-FIRM
Official Title
Randomized Evaluation of Redo Ablation Procedures of Atrial Fibrillation With Focal Impulse and Rotor Modulation Guided Procedures (REDO-FIRM)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
July 2020 (Actual)
Study Completion Date
July 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation
Keywords
FIRMap, Rotor, FIRM-guided procedure

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
269 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard PVI
Arm Type
Active Comparator
Arm Description
Standard catheter ablation including pulmonary vein isolation (PVI) procedure.
Arm Title
FIRM-guided Procedure and PVI
Arm Type
Experimental
Arm Description
FIRM-guided procedure followed by PVI.
Intervention Type
Procedure
Intervention Name(s)
Standard PVI
Other Intervention Name(s)
Pulmonary vein isolation, Ablation, Arrhythmia, Atrial fibrillation Mapping
Intervention Description
Standard PVI procedure without FIRMap.
Intervention Type
Procedure
Intervention Name(s)
FIRM-Guided Procedure and PVI
Other Intervention Name(s)
Pulmonary vein isolation, Atrial fibrillation Mapping, FIRMap
Primary Outcome Measure Information:
Title
Freedom from atrial fibrillation atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) recurrence at 12 months post procedure.
Description
Single procedure freedom from recurrence from 3-12 months post procedure
Time Frame
12 months post procedure
Title
Freedom from serious adverse events related to the procedure
Description
Freedom from any procedure-related serious adverse event from 0-10 days post procedure
Time Frame
10-day post procedure
Title
Freedom from serious adverse events related to the procedure
Description
Freedom from any procedure-related serious adverse event from 0-12 months post procedure
Time Frame
12-month post procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vivek Reddy, MD
Organizational Affiliation
MOUNT SINAI HOSPITAL
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stefan G. Spitzer, MD
Organizational Affiliation
Praxisklinik Herz und Gefäße Dresden, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arizona Heart Rhythm Research Cente
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Ventura Cardiology Consultants
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
Facility Name
Broward Health
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
St. Vincent's HealthCare
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Loyola University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Northwestern University - Bluhm Cardiovascular Institute
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Englewood Hospital and Medical Center
City
Englewood
State/Province
New Jersey
ZIP/Postal Code
07631
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
University of Pennsylvania Health System
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Virginia Heart
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
University Hospital of Antwerp
City
Antwerp
State/Province
Flanders
Country
Belgium
Facility Name
Klinikum Coburg
City
Coburg
State/Province
Bavaria
Country
Germany
Facility Name
Furth Medical Clinic for Heart and Lung Diseases
City
Fürth
State/Province
Bavaria
Country
Germany
Facility Name
The Dr. Müller Kliniken
City
Munich
State/Province
Bavaria
Country
Germany
Facility Name
Kardiologische Gemeinschaftspraxis am Park Sanssouci
City
Potsdam
State/Province
Brandenburg
Country
Germany
Facility Name
Kardiocentrum Frankfurt
City
Frankfurt
State/Province
Main
Country
Germany
Facility Name
Leipzig Heart Institute GmbH
City
Leipzig
State/Province
Saxony
Country
Germany
Facility Name
Luebeck University Heart Center
City
Lübeck
State/Province
Schleswig-Holstein
Country
Germany
Facility Name
Ruhr University Bochum - Heart and Diabetes Center North Rhine-Westphalia
City
Bad Oeynhausen
Country
Germany
Facility Name
UKB (Unfallkrankenhaus Berlin)
City
Berlin
Country
Germany
Facility Name
Praxisklinik Herz und Gefäße Dresden
City
Dresden
Country
Germany
Facility Name
Medical Center Rotterdam (Erasmus MC)
City
Rotterdam
State/Province
South Holland
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Randomized Evaluation of Redo Ablation Procedures of Atrial Fibrillation With FIRM Guided Procedures

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