Comparison of a Single Versus Double Perclose Technique for TAVR

Launched by SECOND AFFILIATED HOSPITAL, SCHOOL OF MEDICINE, ZHEJIANG UNIVERSITY · Dec 7, 2023

Keywords

ClinConnect Summary

This clinical trial is studying two different techniques for closing the blood vessels after a procedure called Transcatheter Aortic Valve Replacement (TAVR), which is used to treat severe aortic stenosis, a condition where the heart's aortic valve narrows and makes it hard for blood to flow. The trial compares a single "Perclose" device to a double Perclose device to see if using just one device can be just as safe and effective as using two. The goal is to find out if the single device method can save time and money while still preventing complications, like bleeding or other issues at the access site where the procedure is done.

To participate in the trial, patients need to be scheduled for a TAVR procedure and be able to follow the study guidelines. They should be in good enough health to undergo the procedure and have the appropriate anatomy for the vascular closure technique. Patients who have certain medical conditions or complications, such as severe bleeding or infections, or who are pregnant, will not be eligible. Those who join the trial can expect to receive the standard care and monitoring during and after their TAVR procedure, while also helping researchers understand which closure technique works best.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients scheduled to undergo transfemoral TAVR were considered for inclusion in the trial if they met all inclusion and none of the exclusion criteria. Inclusion criteria were an indication for TAVR as judged by the local heart team; selection of the transfemoral access route and a commercially available transcatheter aortic valve; and willingness to comply with protocol specified follow-up evaluations.
• Exclusion Criteria:
• • Principal exclusion criteria were a vascular access site anatomy not suitable for percutaneous vascular closure and the occurrence of vascular access site complications before the TAVR procedure. Additional exclusion criteria were a known allergy or hypersensitivity to any VCD component; unstable active bleeding or bleeding diathesis or significant unman ageable anemia; absence of computed tomographic data of the access site before the procedure; systemic infection or a local infection at or near the access site; life expectancy of \<6 months because of noncardiac conditions; patients who can-not adhere to or complete the investigational protocol for any reason; pregnant or nursing patients; and participation in any other interventional trial.