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

Paroxysmal Atrial Fibrillation Clinical Trial

— REDO-FIRM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02799043
• Other study ID #: REDO-FIRM
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: July 2020

Study information

• Verified date: January 2021
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 269
• Est. completion date: July 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation
• Persistent Atrial Fibrillation

Intervention

Procedure:
• Standard PVI
Standard PVI procedure without FIRMap.
• FIRM-Guided Procedure and PVI

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

United States,  Belgium,  Germany,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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