Left Atrial Appendage (LAA) Occluders After Catheter Ablation of Atrial Fibrillation

Study Overview
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Brief Summary
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The primary objective of this study is to assess combined end point (All stroke, Systemic embolism, Cardiovascular death) between two groups.

Official Title
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Implantation of Left Atrial Appendage Occluders Concomitantly With Catheter Ablation in Patients With Atrial Fibrillation

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: LAA occluder
* Procedure: RFA ablation
* Drug: Warfarin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has paroxysmal, persistent or permanent non-valvular atrial fibrillation (AF) Eligible for long term warfarin CHADS score >= 1 (congestive heart failure [CHF], history of high blood pressure, 75 years of age or older, diabetes, prior stroke or transient ischemic attack [TIA]) Exclusion Criteria: Contraindicated for warfarin Contraindicated for aspirin or clopidogrel (Plavix) CHF Class 4 Implanted mechanical valve Atrial septal or Patent Foramen Ovale (PFO) device Platelets < 100,000 or hemoglobin < 10 Left ventricular ejection fraction (LVEF) < 30%

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LAA occluder<br> | Device: LAA occluder<br>* The procedure is performed under transesophageal echocardiographic (TEE) guidance. After a transseptal puncture is performed, a pigtail catheter is maneuvered into the LAA to perform an LAA angiogram. Through the use of a combination of this angiographic and TEE information, a Watchman device, ranging in size between 21 and 33 mm in diameter, is selected. The device comes prepackaged in a catheter-based delivery system that is advanced into the LAA through a 12F transseptal sheath (outer diameter, 14F). Proper positioning and stability of the device are verified by TEE and angiography before device release.<br>* Other names: Watchman;Procedure: RFA ablation<br>* The left atrium (LA) and pulmonary veins (PVs) were explored through a transseptal approach. Real-time three-dimensional (3D) LA maps were reconstructed by using a nonfluoroscopic navigation system (CARTO, Biosense-Webster Inc.). The ipsilateral left and right PVs were encircled in 1 lesion line by circumferential PV isolation. Radiofrequency energy was delivered at 43◦C, 35 W, 0.5 cm away from the PV ostia at the anterior wall, and was reduced to 43◦C, 30 W, 1 cm away from the PV ostia at the posterior wall, with a saline irrigation speed of 17 mL/min. Each lesion was ablated continuously until the local potential amplitude decreased by >80% or RF energy deliveries exceeded 40 seconds. The endpoint of circumferential PV isolation was PV isolation; this was confirmed when Lasso mapping showed the disappearance of all PV potentials or the dissociation of PV potentials from left atrial activity.<br>Drug: Warfarin<br>* Warfarin was discontinued in 45 days after procedure in case of no trombus by TE for Watchman group All patients in Warfarin group continued to receive Warfarin during hole study period with IMR from II to III.<br>|
| Active Comparator: Warfarin<br> | Procedure: RFA ablation<br>* The left atrium (LA) and pulmonary veins (PVs) were explored through a transseptal approach. Real-time three-dimensional (3D) LA maps were reconstructed by using a nonfluoroscopic navigation system (CARTO, Biosense-Webster Inc.). The ipsilateral left and right PVs were encircled in 1 lesion line by circumferential PV isolation. Radiofrequency energy was delivered at 43◦C, 35 W, 0.5 cm away from the PV ostia at the anterior wall, and was reduced to 43◦C, 30 W, 1 cm away from the PV ostia at the posterior wall, with a saline irrigation speed of 17 mL/min. Each lesion was ablated continuously until the local potential amplitude decreased by >80% or RF energy deliveries exceeded 40 seconds. The endpoint of circumferential PV isolation was PV isolation; this was confirmed when Lasso mapping showed the disappearance of all PV potentials or the dissociation of PV potentials from left atrial activity.<br>Drug: Warfarin<br>* Warfarin was discontinued in 45 days after procedure in case of no trombus by TE for Watchman group All patients in Warfarin group continued to receive Warfarin during hole study period with IMR from II to III.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All stroke |  | 12 months | 
| Systemic embolism |  | 12 months | 
| Cardiovascular death |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success |  | 45 days | 
| Procedure success |  | 45 days | 
| 30 day major adverse event (MAE) |  | 30 days | 
| Left atrial appendage (LAA) coverage |  | 45 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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catheter ablation