Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02799043
Other study ID # REDO-FIRM
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Completed NCT05970120 - A Study of Intracardiac Ultrasound With the NUVISION NAV Ultrasound Catheter N/A
Recruiting NCT06014996 - Comparison of PFA vs. RFA in Patients With Symptomatic Paroxysmal Atrial Fibrillation. N/A
Completed NCT03624881 - Evaluation of VISITAG SURPOINT™ Module With External Processing Unit (EPU) Phase 4
Recruiting NCT05416086 - iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study N/A
Recruiting NCT05905835 - Treatment of PAF With the Synaptic System N/A
Active, not recruiting NCT05534581 - SINGLE SHOT CHAMPION Phase 4
Active, not recruiting NCT05618340 - PFA for Paroxysmal Atrial Fibrillation N/A
Not yet recruiting NCT05024630 - Renal Denervation and pUlmonary Vein isolAtion With cryoabLation on Patients With Atrial Fibrillation and hypErtension N/A
Completed NCT01913522 - Cryoballoon vs. Irrigated Radiofrequency Catheter Ablation: Double Short vs. Standard Exposure Duration N/A
Completed NCT02610803 - Paroxysmal Atrial Fibrillation in Patients With Acute Ischemic Stroke N/A
Terminated NCT01925885 - Focal Impulse and Rotor Modulation Ablation Trial for Treatment of Paroxysmal Atrial Fibrillation (FIRMAT-PAF) N/A
Withdrawn NCT01917981 - Testing the Accuracy of a Personal Heart Rhythm Monitor to Detect Prolonged Paroxysmal Atrial Fibrillation Phase 3
Completed NCT01693107 - Atrial Fibrillation Force Contact Ablation Study
Completed NCT01842529 - Botulinum Toxin Injection in Epicardial Fat Pads To Treat Atrial Fibrillation After Cardiac Surgery Phase 2
Completed NCT00971204 - Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (EAS-AC) for the Treatment of Symptomatic Atrial Fibrillation Phase 2
Completed NCT05043883 - Automated Assessment of PVI Using a Novel EP Recording System N/A
Recruiting NCT05172765 - Biomarker-Guided Optimization of Transcutaneous Vagal Stimulation for Atrial (BiG tVNS-AF) N/A
Recruiting NCT04529785 - Added Value of Vein of Marshal Ethanol Infusion Compared to Superior Vena Cava Isolation Alone in Patients Undergoing Repeat Ablation for Recurrent Paroxysmal Atrial Fibrillation Despite Durable PV Isolation N/A
Completed NCT04022954 - HD Mapping of Atrial Fibrillation in Asia Pacific
Completed NCT00964392 - NAVISTAR® THERMOCOOL® Catheter Post Approval Registry Phase 4