NL-OMON43707
Completed
Not Applicable
Randomized Evaluation of Atrial Fibrillation treatment with focal impulse and Rotor Modulation guided procedure ( REAFFIRM) - REAFFIRM
Abbott Electrophysiology0 sites50 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Abnormal heartritme
- Sponsor
- Abbott Electrophysiology
- Enrollment
- 50
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
- •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 \< 35%.
- •4\.History of myocardial infarction (MI) within the past three months.
- •5\.Any concomitant arrhythmia or therapy that could interfere with the interpretation of the results from this study.
- •6\.ASD closure device, LAA closure device, prosthetic mitral or tricuspid valve and permanent pacemakers or defribrillator leads
- •7\.Untreatable allergy to contrast media.
Outcomes
Primary Outcomes
Not specified
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