The primary objective of this study is to assess combined end point (All stroke, Systemic embolism, Cardiovascular death) between two groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
96
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.
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.
State Research Institute of CIrculation Pathology
Novosibirsk, Russia
All stroke
Time frame: 12 months
Systemic embolism
Time frame: 12 months
Cardiovascular death
Time frame: 12 months
Technical success
Time frame: 45 days
Procedure success
Time frame: 45 days
30 day major adverse event (MAE)
Time frame: 30 days
Left atrial appendage (LAA) coverage
Time frame: 45 days
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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.