NCT01695824

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Meshalkin Research Institute of Pathology of Circulation · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	LAA occluder	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.
PROCEDURE	RFA ablation	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.
DRUG	Warfarin	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.

Timeline

• Start date: 2011-12-01
• Primary completion: 2014-11-01
• Completion: 2014-11-01
• First posted: 2012-09-28
• Last updated: 2015-07-08

Locations

1 site across 1 country: Russia