Abnormal heartritme persistent atrial fibrilation
Conditions
Interventions
Block randomization using a web-based database system will be used to assign
subjects (1:1) to the conventional AF ablation treatment without FIRM-guided
diagnostic procedure, or to the FIRM-guided
Sponsors
Abbott Electrophysiology
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: -1.Male or female 18 - 80 years of age. 2.Experiencing at least two (2) documented episodes of persistent atrial fibrillation (including long standing persistent) during the 3 months preceding study entry with clinical indication for AF ablation per guidelines. At least one episode must be documented by rhythm strip or ECG. 3.Refractory, contraindicated, or intolerant to Class I or III anti-arrhythmic medications. Drug doses must be therapeutic and stable. 4.Oral anticoagulation required with either Novel Oral Anticoagulant (e.g. dabigatran, rivaroxaban, apixaban), Warfarin (therapeutic INR >= 2.0 for at least three weeks prior to randomization), or other similar standard-of-care oral anticoagulant therapy is required (aspirin is not considered similar) 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.Prior stroke or transient ischemic attack e.Congestive heart failure f.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 has CHADS2 score >= 2.
Exclusion criteria
Exclusion criteria: 1.Presence of structural heart disease of clinical significance including:Coronary artery disease with either: oCoronary artery bypass surgery (CABG) within the last six months, or oStable/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 |
|---|---|
| 1. Safety endpoints: Freedom from serious adverse events related to the procedure within 7-10 days of the procedure; and Freedom from cumulative serious adverse events related to the procedure (including any repeat procedures required) within one year of the initial procedure . 2.2) Effectiveness endpoints: Single Procedure Freedom from AF/AT recurrence at 3 months; and Single Procedure Freedom from AF/AT recurrence from 3-12 months after the initial AF ablation procedure | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)The acute success of FIRM-guided procedure is defined as elimination of the source of arrhythmias identified by FIRMap 2) EQ-5D scores pre-procedure will be compared to those post-procedure at all time points separately and together. | — |
Countries
Netherlands
Outcome results
None listed