TVMR With the Innovalve System Trial - First In Human Israel

Absence of implant or delivery related serious adverse events

All of the below:

i. Absence of procedural mortality; and ii. Successful access, delivery, and retrieval of the device delivery system; and iii. Successful deployment and correct positioning of the first intended device; and iv. Freedom from emergency surgery or reintervention related to the device or access procedure.

All of the following must be present:

I. Deployment of the device

II. Absence of major device or procedure related serious adverse events, including:

• Death
• Stroke
• Life-threatening bleeding (MVARC scale)
• Major vascular complications
• Major cardiac structural complications
• Stage 2 or 3 acute kidney injury (includes new dialysis)
• Myocardial infarction or coronary ischemia requiring PCI or CABG
• Severe hypotension, heart failure, or respiratory failure requiring intravenous pressors or invasive or mechanical heart failure treatments such as ultrafiltration or hemodynamic assist devices, including intra-aortic balloon pumps or left ventricular or biventricular assist devices, or prolonged intubation for 48 h.
• Any valve-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention