Randomized Evaluation of Atrial Fibrillation Treatment With Focal Impulse and Rotor Modulation Guided Procedures (REAFFIRM)
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|ClinicalTrials.gov Identifier: NCT02274857|
Recruitment Status : Completed
First Posted : October 24, 2014
Results First Posted : February 7, 2020
Last Update Posted : February 7, 2020
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|Condition or disease||Intervention/treatment||Phase|
|Persistent Atrial Fibrillation||Procedure: Standard PVI Ablation Procedure: FIRM-Guided Procedure and PVI||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||350 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
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.
- Freedom From Procedure-related Serious Adverse Events (SAEs) Within 7-10 Days of the Procedure [ Time Frame: Within 7-10 days of the Procedure ]
- Single-procedure Freedom From AF/AT Recurrence at 3 Month Post Index Procedure. [ Time Frame: 3-month follow up ]
- Single-procedure Freedom From AF/AT Recurrence at 3 to 12 Months Post Index Procedure. [ Time Frame: 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 [ Time Frame: 3 to 12 months post study treatment ]
- 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 ]
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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|
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.
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
|Principal Investigator:||Johannes Brachmann, MD||Klinikum Coburg GmbH|
Documents provided by Abbott Medical Devices:
|Responsible Party:||Abbott Medical Devices|
|Other Study ID Numbers:||
|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|
Focal Impulse and Rotor Modulation Mapping Catheter (FIRMap)