Randomized Evaluation of Atrial Fibrillation Treatment With Focal Impulse and Rotor Modulation Guided Procedures

Not Applicable

Completed

Interventions: Procedure: Standard PVI Ablation
Procedure: FIRM-Guided Procedure and PVI

Brief Summary: The study is a prospective, multicenter, randomized study to assess the safety and effectiveness of FIRM procedures followed by conventional ablation including PVI versus a standard PVI procedure for the treatment of persistent atrial fibrillation (AF).

Recruitment & Eligibility

Inclusion Criteria

At least two (2) documented episodes of persistent atrial fibrillation during prior 3 months
Refractory, intolerant, or contraindicated to Class I or III anti-arrhythmic medications
Left atrial diameter < 6.0 cm

Key

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Standard PVI Ablation	Standard PVI Ablation	Standard catheter ablation including pulmonary vein isolation (PVI) procedure for the treatment of persistent AF.
FIRM-guided Procedure and PVI	FIRM-Guided Procedure and PVI	FIRM-guided procedure followed by standard catheter ablation including PVI.

Primary Outcome Measures

Name	Time	Method
Freedom From Procedure-related Serious Adverse Events (SAEs) Within 7-10 Days of the Procedure	Within 7-10 days of the Procedure
Single-procedure Freedom From AF/AT Recurrence at 3 Month Post Index Procedure.	3-month follow up
Single-procedure Freedom From AF/AT Recurrence at 3 to 12 Months Post Index Procedure.	3-12 months post study treatment
Freedom From Procedure-related SAEs (Including Those Related to Any Repeat Procedures) Within 12-months of the Initial Procedure	3 to 12 months post study treatment

Secondary Outcome Measures

Name	Time	Method
Evaluate the Acute Effectiveness of FIRM-guided Procedures in Eliminating the Source of Arrhythmia as Shown by: No Evidence of the Source in FIRMap Post-op, OR Reduction of Electrogram Amplitude to < 0.2 Millivolts	Immediately post procedure

Locations (18): Hoag Memorial Hospital Presbyterian
🇺🇸
Newport Beach, California, United States
Weill Medical College at Cornell University
🇺🇸
New York, New York, United States
Loyola University Medical Center
🇺🇸
Maywood, Illinois, United States
The Johns Hopkins Hospital
🇺🇸
Baltimore, Maryland, United States
Hackensack UMC
🇺🇸
Hackensack, New Jersey, United States
The Ohio State University
🇺🇸
Columbus, Ohio, United States
Geisinger Wyoming Valley Medical Center
🇺🇸
Wilkes-Barre, Pennsylvania, United States
Herz- und Diabeteszentrum Bad Oeynhausen
🇩🇪
Bad Oeynhausen, Minden-Lübbecke, Germany
Klinikum Coburg GmbH
🇩🇪
Coburg, Germany
Zentrum für klinische Prüfungen in der Facharztzentrum Dresden-Neustadt GbR
🇩🇪
Dresden, Germany
Kardiologische Gemeinschaftspraxis am Park Sanssouci
🇩🇪
Potsdam, Germany
Leipzig Heart Institute GmbH
🇩🇪
Leipzig, Germany
Städtisches Klinikum Karlsruhe gGmbH
🇩🇪
Karlsruhe, Germany
Erasmus Medical Center
🇳🇱
Rotterdam, Netherlands
Arizona Heart Rhythm Center
🇺🇸
Phoenix, Arizona, United States
St. Vincent Hospital
🇺🇸
Indianapolis, Indiana, United States
Indiana University - Krannert Institute of Cardiology
🇺🇸
Indianapolis, Indiana, United States
Unfallkrankenhaus Berlin
🇩🇪
Berlin, Germany