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Trial record 1 of 1 for:    NCT02274857
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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
Results First Posted : February 7, 2020
Last Update Posted : February 7, 2020
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Study Description
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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).

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

Study Design
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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


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Freedom From Procedure-related Serious Adverse Events (SAEs) Within 7-10 Days of the Procedure [ Time Frame: Within 7-10 days of the Procedure ]
  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 ]
  4. Freedom From Procedure-related SAEs (Including Those Related to Any Repeat Procedures) Within 12-months of the Initial Procedure [ Time Frame: 3 to 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 < 0.2 Millivolts [ Time Frame: Immediately post procedure ]

Eligibility Criteria
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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
  • New York Heart Association (NYHA) Class IV.
  • Ejection fraction < 35%.
  • History of myocardial infarction (MI) within the past three months.
Contacts and Locations
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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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Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Principal Investigator: Johannes Brachmann, MD Klinikum Coburg GmbH
  Study Documents (Full-Text)

Documents provided by Abbott Medical Devices:
Statistical Analysis Plan  [PDF] August 5, 2014
Study Protocol  [PDF] June 17, 2014

More Information
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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT02274857    
Other Study ID Numbers: REAFFIRM
First Posted: October 24, 2014    Key Record Dates
Results First Posted: February 7, 2020
Last Update Posted: February 7, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Abbott Medical Devices:
Focal Impulse and Rotor Modulation Mapping Catheter (FIRMap)
Rotor
FIRM-guided procedure
REAFFIRM
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes