honeybunny
Well-known member
I've agreed to participate in the clinical trial H-33047 Multi-Center Experience with the Rapid Deployment Edwards Intuity Valve System for AVR (Transform Trial).
I was approached by a research coordinator following my heat cath yesterday (prep for my 9/30/15 AVR surgery) and readily agreed for two reasons: 1) less time on the heart--lung machine and 2) follow up care for5 years or longer. A description of the trial can be found at www.ClinicalTrials.gov.
The valve was described as a "bridge" between traditional OHS and TAVR. They will go through the sternum. It will be "dropped" then stitched into place with two sutures instead of 25.
Some may think it imprudent to go with a new valve type but I am excited about it. My biggest concern has been side effects of being on the heart-lung machine; hopefully the possibility of those side effects will be reduced. My surgeon and cardiologist are pioneers in their fields and I trust them completely. I will possibly be helping people down the road by participating in this research. Finally, I once worked as a clerk in a research department of a teaching hospital and am familiar with the effort surrounding human protocols. My risks should be no greater from this valve than from another tissue valve.
I am optimistic all will go even better than I have anticipated.
I was approached by a research coordinator following my heat cath yesterday (prep for my 9/30/15 AVR surgery) and readily agreed for two reasons: 1) less time on the heart--lung machine and 2) follow up care for5 years or longer. A description of the trial can be found at www.ClinicalTrials.gov.
The valve was described as a "bridge" between traditional OHS and TAVR. They will go through the sternum. It will be "dropped" then stitched into place with two sutures instead of 25.
Some may think it imprudent to go with a new valve type but I am excited about it. My biggest concern has been side effects of being on the heart-lung machine; hopefully the possibility of those side effects will be reduced. My surgeon and cardiologist are pioneers in their fields and I trust them completely. I will possibly be helping people down the road by participating in this research. Finally, I once worked as a clerk in a research department of a teaching hospital and am familiar with the effort surrounding human protocols. My risks should be no greater from this valve than from another tissue valve.
I am optimistic all will go even better than I have anticipated.
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