Randomized Evaluation of Redo Ablation Procedures of Atrial Fibrillation With FIRM Guided Procedures
NCT ID: NCT02799043
Last Updated: 2024-09-19
Study Results
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View full resultsBasic Information
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COMPLETED
NA
269 participants
INTERVENTIONAL
2016-06-30
2020-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Standard PVI
Standard catheter ablation including pulmonary vein isolation (PVI) procedure.
Standard PVI
Standard PVI procedure without FIRMap.
FIRM-guided Procedure and PVI
FIRM-guided procedure followed by PVI.
FIRM-Guided Procedure and PVI
Interventions
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Standard PVI
Standard PVI procedure without FIRMap.
FIRM-Guided Procedure and PVI
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Vivek Reddy, MD
Role: PRINCIPAL_INVESTIGATOR
MOUNT SINAI HOSPITAL
Stefan G. Spitzer, MD
Role: PRINCIPAL_INVESTIGATOR
Praxisklinik Herz und Gefäße Dresden, Germany
Locations
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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
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Virginia Heart
Falls Church, Virginia, United States
University Hospital of Antwerp
Antwerp, Flanders, Belgium
Klinikum Coburg
Coburg, Bavaria, Germany
Furth Medical Clinic for Heart and Lung Diseases
Fürth, Bavaria, Germany
The Dr. Müller Kliniken
Munich, Bavaria, Germany
Kardiologische Gemeinschaftspraxis am Park Sanssouci
Potsdam, Brandenburg, Germany
Kardiocentrum Frankfurt
Frankfurt, Main, Germany
Leipzig Heart Institute GmbH
Leipzig, Saxony, Germany
Luebeck University Heart Center
Lübeck, Schleswig-Holstein, Germany
Ruhr University Bochum - Heart and Diabetes Center North Rhine-Westphalia
Bad Oeynhausen, , Germany
UKB (Unfallkrankenhaus Berlin)
Berlin, , Germany
Praxisklinik Herz und Gefäße Dresden
Dresden, , Germany
Medical Center Rotterdam (Erasmus MC)
Rotterdam, South Holland, Netherlands
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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REDO-FIRM
Identifier Type: -
Identifier Source: org_study_id
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