Author + information
- Howard Leonhardt,
- Jorge Genovese,
- Mark Cunningham,
- Leslie Miller and
- Amit Patel
In the early 1990's our team developed and patented one of the first percutaneous heart valve systems working with Dr. Ivan Casagrande and Dr. Domingos Moraes in Brazil. We learned in this experience that a patient is nearly always better off keeping their own heart valve it they can.
The aim of this study was to evaluate the safety, technical feasibility and performance of a new trans-catheter heart valve repair system.
Methods and Results
Ten adult swine will be pre-conditioned with Cadherin-11 (Cad-11 upregulates RhoA and Sox9) to induce aortic valve calcification and will undergo transcatheter heart valve repair utilizing the Valvublator TM heart valve decalcification and regeneration system. The steerable transcatheter device will be introduced through a 14FR to 24FR sheath via minimally invasive access to the aortic valve with a beating heart. The Valvublator TM device will first use a vibrating burr at the end of the deflecting tip catheter under optical guidance to debulk the calcification followed by ultrasonic and bio safe solvent secondary cleanings. The brain is protected from stroke during this procedure with the Keystone Heart deflector or another FDA approved cerebral protection device. The decalcification procedure is followed by multiple sessions (4) of 40 minutes each of delivering bioelectric regeneration signals to the valve leaflets and orifice that recruits stem cells and differentiates them into healthy valvular tissue. Two sessions of bioelectric energy delivery are done via an endovascular catheter with an signal transmission array at the tip and two are done non-invasively with an external wireless signal transmitter focally pointed to the valve. Before and after images will be taken and functional assessment will be made before and after the procedure. Five of the swine (50%) will receive CoroStim TM vibrational energy via an external non-invasive transmitter to determine if this followup technology reduces re-calcification of the heart valve leaflets. All animals will be assessed at 3 months followup for valve calcification levels and functional status.
This study is designed to determine if percutaneous beating heart decalcification and regeneration of aortic valves is feasible, safe and effective.