The PROTECT AF trial was a randomized controlled trial comparing percutaneous left atrial appendage closure using the WATCHMAN device versus long-term warfarin therapy for stroke prevention in patients with non-valvular atrial fibrillation. The trial found that the device was non-inferior to warfarin for preventing all strokes and deaths, and superior for preventing hemorrhagic strokes. The device was associated with early safety events such as pericardial effusions that decreased over time, and most patients were able to stop warfarin within 45 days of the procedure. The trial demonstrated that the WATCHMAN device offers a safe and effective alternative to long-term warfarin therapy in appropriate patients
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Protect Af Holmes2
1. PROTECT AF Trial: Randomized Prospective Trial of Percutaneous LAA Closure vs Warfarin for Stroke Prevention in AF ACC & i2 Summit 2009 David Holmes, MD Vivek Reddy, MD Zoltan Turi, MD Shephal Doshi, MD Horst Sievert, MD Christopher M. Mullin, MS Peter Sick, MD Relevant Financial Relationship(s) Mayo receives research support from Atritech and may receive royalties
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6. Watchman LAA Closure Technology The WATCHMAN LAA Closure Technology is designed to prevent embolization of thrombi that may form in the LAA. The WATCHMAN ® Left Atrial Appendage Closure Technology is intended as an alternative to warfarin therapy for patients with non-valvular atrial fibrillation.
9. Patient Study Timeline Device subject takes warfarin Preimplant interval Day 0 Control subject takes warfarin Device subject gets implant Device subject has ceased warfarin Ongoing to 5 years Randomize Day 0 Day 45 postimplant Day 2-14 Ongoing to 5 years Device Control 3000838-60