Clinical trial NCT02799043: Randomized Evaluation of Redo Ablation Procedures of Atrial Fibrillation With FIRM Guided Procedures
Official title: Randomized Evaluation of Redo Ablation Procedures of Atrial Fibrillation With Focal Impulse and Rotor Modulation Guided Procedures (REDO-FIRM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Persistent Atrial Fibrillation
Paroxysmal Atrial Fibrillation
Keywords: FIRMap, Rotor, FIRM-guided procedure
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2016-06-14
Enrollment: 269
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Freedom From Atrial Fibrillation Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Recurrence at 12 Months Post Procedure.
timeFrame: 12 months post procedure
measure: Freedom From Serious Adverse Events Related to the Procedure
timeFrame: 10-day post procedure
measure: Freedom From Serious Adverse Events Related to the Procedure
timeFrame: 12-month post procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Heart Rhythm Research Cente
state: Arizona
city: Ventura
country: United States
facility: Ventura Cardiology Consultants
state: California
city: Fort Lauderdale
country: United States
facility: Broward Health
state: Florida
city: Jacksonville
country: United States
facility: St. Vincent's HealthCare
state: Florida
city: Chicago
country: United States
facility: Loyola University
state: Illinois
city: Chicago
country: United States
facility: Northwestern University - Bluhm Cardiovascular Institute
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Englewood
country: United States
facility: Englewood Hospital and Medical Center
state: New Jersey
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania Health System
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Falls Church
country: United States
facility: Virginia Heart
state: Virginia
city: Antwerp
country: Belgium
facility: University Hospital of Antwerp
state: Flanders
city: Coburg
country: Germany
facility: Klinikum Coburg
state: Bavaria
city: Fürth
country: Germany
facility: Furth Medical Clinic for Heart and Lung Diseases
state: Bavaria
city: Munich
country: Germany
facility: The Dr. Müller Kliniken
state: Bavaria
city: Potsdam
country: Germany
facility: Kardiologische Gemeinschaftspraxis am Park Sanssouci
state: Brandenburg
city: Frankfurt
country: Germany
facility: Kardiocentrum Frankfurt
state: Main
city: Leipzig
country: Germany
facility: Leipzig Heart Institute GmbH
state: Saxony
city: Lübeck
country: Germany
facility: Luebeck University Heart Center
state: Schleswig-Holstein
city: Bad Oeynhausen
country: Germany
facility: Ruhr University Bochum - Heart and Diabetes Center North Rhine-Westphalia
city: Berlin
country: Germany
facility: UKB (Unfallkrankenhaus Berlin)
city: Dresden
country: Germany
facility: Praxisklinik Herz und Gefäße Dresden
city: Rotterdam
country: Netherlands
facility: Medical Center Rotterdam (Erasmus MC)
state: South Holland
Study officials:
affiliation: MOUNT SINAI HOSPITAL
name: Vivek Reddy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Praxisklinik Herz und Gefäße Dresden, Germany
name: Stefan G. Spitzer, MD
role: PRINCIPAL_INVESTIGATOR
References: