New trial to test transcatheter ventricular enhancement procedure
A new clinical trial is underway to test a closed-chest procedure designed to treat patients with ischemic cardiomyopathy.
The trial's first patient has been implanted with the Revivent TC TransCatheter Ventricular Enhancement System, according to a press release issued Aug. 21 by BioVentrix.
In the procedure, small titanium anchors are placed along the outer surface of the heart and along one interior wall. The anchors are then pulled toward each other, effectively excluding the scarred and non-functioning heart wall and reducing ventricular volume by as much as 30 to 40 percent, according to BioVentrix.
A pair of doctors performed the procedure at Papworth Hospital in Cambridge, United Kingdom. They reshaped a 60-year-old patient’s left ventricle, decreased his left ventricular end systolic volume index and increased ejection fraction.
"The TransCatheter delivery system allows for more ischemic heart failure patients to be treated with reduced procedural risk relative to conventional surgery,” interventional cardiologist Michael O’Sullivan, one of the doctors who performed the procedure, said in a statement.
“Most importantly, this procedure enabled us to achieve a considerable amount of LV volume reduction without the need for open heart surgery or cardiopulmonary bypass.”
The trial plans to enroll 120 patients at up to 20 sites in the U.K. and United States with a one-year follow-up analysis. Endpoints include positive effects on volume reduction, ejection fraction, quality of life, New York Heart Association classification, a 6-minute walk test and rehospitalization.
The Revivent TC system has received CE mark approval. It received investigational device exemption approval for the study from the U.S. Food and Drug Administration.
Daniel joined TriMed’s Chicago editorial team in 2017 as a Cardiovascular Business writer. He previously worked as a writer for daily newspapers in North Dakota and Indiana.