N/A
N=269
Randomized Evaluation of Redo Ablation Procedures of Atrial Fibrillation With FIRM Guided Procedures
Persistent Atrial Fibrillation · Paroxysmal Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT02799043 ↗Enrolled (actual)
269
Serious AEs
8.3%
Results posted
Sep 2024
Primary outcome: Primary: Freedom From Atrial Fibrillation Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Recurrence at 12 Months Post Procedure. — 72; 76 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Standard PVI (Procedure); FIRM-Guided Procedure and PVI (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- Jul 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Freedom From Atrial Fibrillation Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Recurrence at 12 Months Post Procedure. |
72; 76 | — |
| PRIMARY Freedom From Serious Adverse Events Related to the Procedure |
113; 107 | — |
| PRIMARY Freedom From Serious Adverse Events Related to the Procedure |
113; 107 | — |
Summary
A prospective, multicenter, randomized study to assess the safety and effectiveness of FIRM-guided procedures in conventional "redo" RF ablation procedures for the treatment of persistent and paroxysmal atrial fibrillation.
Eligibility Criteria
Inclusion Criteria
- Experiencing at least one (1) documented episode of spontaneous persistent or paroxysmal atrial fibrillation during the last 3 months by rhythm strip/ECG.
- One (1) previous AF ablation (PVI-only - any technology) after Jan-01-2013, but NOT within the last 3 months.
- Left atrial diameter 5 min uninterrupted).
Exclusion Criteria
- Presence of structural heart disease with clinical significance
- NYHA Class IV
- Ejection fraction < 35%
- Previous AF ablation within the last 3 months
- ASD closure device, LAA closure device, prosthetic mitral or tricuspid valve, or permanent pacemaker.
- History of myocardial infarction (MI) within the past three (3) months
- Atrial clot/thrombus noted within 72 hours of the procedure
Data sourced from ClinicalTrials.gov (NCT02799043). 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.