OpSens, a Canada-based medical device cardiology-focused company, has completed enrolment of participants for the SAFE‑TAVI clinical study in Europe.
The SAFE-TAVI study, which has enrolled 120 patients, is designed to evaluate left ventricular rapid-pacing utilising OpSens’ SavvyWire in transcatheter aortic valve implantation procedures (TAVI or TAVR).
The participants enrolled were those with severe aortic valve stenosis and other conditions that needed a TAVI procedure in which left ventricular rapid pacing was deemed as required.
The study was undertaken in nine hospitals including eight centres across Spain and one in Canada, at Quebec Heart and Lung Institute – Laval University (IUCPQ).
Serving as the global principal investigator of the study, Dr Josep Rodés-Cabau from IUCPQ oversaw and coordinated with the principal investigators from the hospitals in Spain.
SavvyWire is leveraged for left ventricular pacing to analyse the potential benefits of removing the requirement for venous access, lowering procedure time and eliminating any potential complications related to right ventricular pacing.
Rodés-Cabau said: “Left ventricular rapid pacing is necessary to restrict the range of motion of the heart muscle during TAVI for optimal valve placement. The rapid pacing feature is important in SavvyWire’s performance in addition to providing real-time, accurate hemodynamic measurement during the TAVI procedure.”
OpSens CEO and president Louis Laflamme said: “We are honoured to partner with Rodés-Cabau and all investigators on SAFE-TAVI. His clinical work has been instrumental in the progression of the TAVI procedure and the treatment of aortic stenosis and many advances in cardiology. We anticipate the clinical data from the SAFE-TAVI study will be published later this year.”
The company secured Health Canada and US FDA approval for SavvyWire last year.
The clinical study is being undertaken as part of OpSens CE Mark clinical strategy to commercialise SavvyWire in Europe.
Serving as more than a wire, SavvyWire is claimed to be the first and only sensor-guided TAVR solution in the world.
It offers a three-in-one solution for stable aortic valve delivery and positioning, continuous and precise hemodynamic measurement during the procedure and dependable left ventricular pacing without requiring adjunct devices or venous access.