Left Atrial Appendage Closure Compared to Standard Antiplatelet Therapy in Patients With AF Who Underwent PCI

PHASE2UnknownINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

May 31, 2015

Primary Completion Date

March 31, 2016

Study Completion Date

December 31, 2017

Conditions
Myocardial Infarction
Interventions
DEVICE

Left Atrial Appendage Closure Device (Watchman)

This device is a self-expanding nickel titanium (nitinol) frame structure with fixation barbs and a permeable polyester fabric cover. The device ranges in diameter from 21 mm to 33 mm to accommodate varying LAA anatomy and size. It will be implanted via a trans-septal approach by use of a catheter based delivery system to seal the ostium of the LAA. The implantation will be guided by fluoroscopy and TEE to verify proper positioning and stability. The dose of warfarin will be adjusted to maintain INR 2.0 - 3.0 for 45 days. If TEE data shows no additional flow in LAA, warfarin will be discontinued: Aspirin dose: 75 mg for all period of study; Clopidogrel dose: 75 mg for 6 months after procedure.

DRUG

Warfarin

"Warfarin dose adjusted to maintain INR 2.0-3.0 for all period of study; Aspirin dose-75mg for 45 days after randomization; Clopidogrel dose-75mg for 6 months after procedure.~All drugs will be started before PCI procedure. Low molecular weight heparins will be used before procedure and will be stopped when INR reach 1.8-2.0."

Trial Locations (1)

630055

RECRUITING

State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation, Novosibirsk

Sponsors
All Listed Sponsors
collaborator

Boston Scientific Corporation

INDUSTRY

lead

Meshalkin Research Institute of Pathology of Circulation

NETWORK