Abnormal heart rhythm persistent atrial fibrilation
Conditions
Interventions
Through randomization (1:1) subjects will be assigned to the conventional AF
ablation treatment without FIRM-guided diagnostic procedure, or to the
FIRM-guided procedure followed by conventional AF
Sponsors
Abbott Electrophysiology
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Male or female 18 - 80 years of age. 2. Has at least one (1) episode of spontaneous persistent or paroxysmal atrial fibrillation documented by rhythm strip/ ECG following the most recent ablation. 3. Had one (1) previous AF ablation after 01 January 2013, but NOT within the last 3 months. Detailed documentation of the previous ablation strategy is required. 4. Oral anticoagulation required with either Novel Oral Anticoagulant (NOAC) or Warfarin (in the case of Warfarin, therapeutic INR >= 2.0 for at least three weeks prior to randomization) for those subjects who meet two or more of the following criteria: a. Age 65 years or older b. Diabetes c. Coronary artery disease (CAD) d. Congestive heart failure e. Hypertension with systolic>165 mm Hg 5. Willingness and able to remain on anti-coagulation therapy for a minimum of 3 months post procedure for all subjects and at least 12 months post procedure if the patient is on anti-coagulation pre-procedure or has CHADS2 score >= 2 (or CHADs-Vasc score >1). 6. Left atrial diameter
Exclusion criteria
Exclusion criteria: 1. Presence of structural heart disease of clinical significance including: a. Coronary artery disease with either: o Coronary artery bypass surgery (CABG) within the last six months, or o Stable/unstable angina or ongoing myocardial ischemia b. Congenital heart disease where either the underlying abnormality or its correction prohibits or increases the risk of ablation. 2. NYHA Class IV. 3. Ejection fraction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The long-term effectiveness of FIRM-guided procedures versus conventional ablation shall be defined as: • Freedom from atrial fibrillation AF/AT/AFL recurrence at 3 -12 months post procedure. Freedom from AF/AT/AFL recurrence is defined as no documented episodes > 30 seconds with conventional non-invasive 7-day monitoring. In the case of a cardiac implanted electronic device (CIED), freedom from AF/AT/AFL recurrence is defined as no documented episodes > 30 seconds in a 1-week window at the follow-up visits, in addition to any symptomatic episodes with documented episode > 30 seconds. AT recurrence does not include episodes of CTI (cavotricuspidisthmus) dependent flutter. Primary Safety Endpoints: Acute success: Freedom from serious adverse events related to the procedure within 10 days of the procedure. Long-term success: Freedom from procedure-related serious adverse events (including those related to repeat procedures) within one year of the initial procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| Acute Effectiveness The acute success of FIRM-guided procedure is defined as elimination of the source of arrhythmia identified by FIRMap as indicated by: 1. No evidence of the source on FIRMap immediately post-procedure, OR 2. Reduction of electrogram amplitude to | — |
Countries
Netherlands
Outcome results
None listed