Randomized Evaluation of Atrial Fibrillation Treatment With Focal Impulse and Rotor Modulation Guided Procedures (REAFFIRM)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Persistent Atrial Fibrillation
- Sponsor
- Abbott Medical Devices
- Enrollment
- 350
- Locations
- 18
- Primary Endpoint
- Freedom From Procedure-related Serious Adverse Events (SAEs) Within 7-10 Days of the Procedure
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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).
Investigators
Eligibility Criteria
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
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.
Outcomes
Primary Outcomes
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
Secondary Outcomes
- 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(Immediately post procedure)