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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02274857
Recruitment Status : Completed
First Posted : October 24, 2014
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

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.

Condition or disease Intervention/treatment Phase
Persistent Atrial Fibrillation Procedure: Standard PVI Ablation Procedure: FIRM-Guided Procedure and PVI Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Randomized Evaluation of Atrial Fibrillation Treatment With Focal Impulse and Rotor Modulation Guided Procedures (REAFFIRM)
Actual Study Start Date : October 2014
Actual Primary Completion Date : November 10, 2018
Actual Study Completion Date : November 10, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Standard PVI Ablation
Standard catheter ablation including pulmonary vein isolation (PVI) procedure for the treatment of persistent AF.
Procedure: Standard PVI Ablation
Standard PVI procedure without FIRMap.
Other Names:
  • Pulmonary vein isolation
  • Ablation
  • Arrhythmia
  • Persistent atrial fibrillation
  • Mapping

Experimental: FIRM-guided Procedure and PVI
FIRM-guided procedure followed by standard catheter ablation including PVI.
Procedure: FIRM-Guided Procedure and PVI
FIRM-guided procedure followed by conventional ablation including PVI.
Other Names:
  • Pulmonary vein isolation
  • Ablation
  • Arrhythmia
  • Persistent atrial fibrillation
  • Mapping
  • FIRMap




Primary Outcome Measures :
  1. Freedom from serious adverse events related to the procedure [ Time Frame: Post treatment through 12-month ]
  2. Single-procedure freedom from AF/AT recurrence at 3 month post index procedure. [ Time Frame: 3-month follow up ]
  3. Single-procedure freedom from AF/AT recurrence at 3 to 12 months post index procedure. [ Time Frame: 3-12 months post study treatment ]

Secondary Outcome Measures :
  1. 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 < 0.2mV [ Time Frame: Immediately post procedure ]
  2. Quality of Life data (EQ-5D and AFEQT) [ Time Frame: 1 - 12 months post index procedure ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key 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:

  • Previous AF Ablation
  • Presence of structural heart disease
  • NYHA Class IV.
  • Ejection fraction < 35%.
  • History of myocardial infarction (MI) within the past three months.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02274857


Locations
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United States, Arizona
Arizona Heart Rhythm Center
Phoenix, Arizona, United States, 85013
United States, California
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92658
United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States, 60153
United States, Indiana
Indiana University - Krannert Institute of Cardiology
Indianapolis, Indiana, United States, 46202
St. Vincent Hospital
Indianapolis, Indiana, United States, 46260
United States, Maryland
The Johns Hopkins Hospital
Baltimore, Maryland, United States
United States, New Jersey
Hackensack UMC
Hackensack, New Jersey, United States
United States, New York
Weill Medical College at Cornell University
New York, New York, United States, 10065
United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, United States
Germany
Herz- und Diabeteszentrum Bad Oeynhausen
Bad Oeynhausen, Minden-Lübbecke, Germany, 32545
Unfallkrankenhaus Berlin
Berlin, Germany, 12683
Klinikum Coburg GmbH
Coburg, Germany, 96450
Zentrum für klinische Prüfungen in der Facharztzentrum Dresden-Neustadt GbR
Dresden, Germany, 01099
Städtisches Klinikum Karlsruhe gGmbH
Karlsruhe, Germany
Leipzig Heart Institute GmbH
Leipzig, Germany, 04289
Kardiologische Gemeinschaftspraxis am Park Sanssouci
Potsdam, Germany, 14471
Netherlands
Erasmus Medical Center
Rotterdam, Netherlands
Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Principal Investigator: Johannes Brachmann, MD Klinikum Coburg GmbH

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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT02274857     History of Changes
Other Study ID Numbers: REAFFIRM
First Posted: October 24, 2014    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Abbott Medical Devices:
FIRMap
Rotor
FIRM-guided procedure
REAFFIRM

Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes