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

Not Applicable

Completed

• Conditions: Persistent Atrial Fibrillation; Paroxysmal Atrial Fibrillation

• Registration Number: NCT02799043
• Lead Sponsor: Abbott Medical Devices

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.

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-02
• Study First Submitted QC: 2016-06-09
• Study First Posted: 2016-06-14
• Primary Completion: 2020-07
• Study Completion: 2020-07
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-07
• Last Update Posted: 2021-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 269

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Freedom From Atrial Fibrillation Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Recurrence at 12 Months Post Procedure.	12 months post procedure	Single procedure freedom from recurrence from 3-12 months post procedure
Freedom From Serious Adverse Events Related to the Procedure	12-month post procedure	Freedom from any procedure-related serious adverse event from 0-12 months post procedure

Trial Locations

Locations (24)

Arizona Heart Rhythm Research Cente; 🇺🇸 Phoenix, Arizona, United States

Ventura Cardiology Consultants; 🇺🇸 Ventura, California, United States

Broward Health; 🇺🇸 Fort Lauderdale, Florida, United States

St. Vincent's HealthCare; 🇺🇸 Jacksonville, Florida, United States

Loyola University; 🇺🇸 Chicago, Illinois, United States

Northwestern University - Bluhm Cardiovascular Institute; 🇺🇸 Chicago, Illinois, United States

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States

Englewood Hospital and Medical Center; 🇺🇸 Englewood, New Jersey, United States

Ohio State University; 🇺🇸 Columbus, Ohio, United States

University of Pennsylvania Health System; 🇺🇸 Philadelphia, Pennsylvania, United States

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