N/A
Completed N=350
Randomized Evaluation of Atrial Fibrillation Treatment With Focal Impulse and Rotor Modulation Guided Procedures
Source: ClinicalTrials.gov NCT02274857 ↗Enrolled (actual)
350
Serious AEs
13.4%
Results posted
Feb 2020
Primary outcomePrimary: Freedom From Procedure-related Serious Adverse Events (SAEs) Within 7-10 Days of the Procedure — 92.7; 88.9 % of participants — p=0.2179
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Freedom From Procedure-related Serious Adverse Events (SAEs) Within 7-10 Days of the Procedure |
92.7; 88.9 | 0.2179 |
| PRIMARY Single-procedure Freedom From AF/AT Recurrence at 3 Month Post Index Procedure. |
76.9; 71.8 | 0.2782 |
| PRIMARY Single-procedure Freedom From AF/AT Recurrence at 3 to 12 Months Post Index Procedure. |
67.5; 69.3 | 0.7266 |
| PRIMARY Freedom From Procedure-related SAEs (Including Those Related to Any Repeat Procedures) Within 12-months of the Initial Procedure |
146; 144 | 0.3522 |
| SECONDARY 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 |
86.1 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02274857). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.