Single Perclose Escalation Technique for Vascular Closure in TAVR

Vall d'Hebron University Hospital (HUVH)

Status: Not yet enrolling

Conditions: Aortic Valve Stenosis; Structural Valve Degeneration; Structural Valve Deterioration

Treatments: Device: One Perclose Proglide Suture; Device: Two Perclose Proglide Suture

Study type: Observational

Funder types: Other

Identifiers

NCT05836311

CLOSURE TAVI 1 VERSUS 2

Details and patient eligibility

About

This study examines in the safety and efficacy of using a single Perclose escalation technique (SPET) using a single Perclose Proglide device to preclose and the need for a rescue device based on a control angiography at the end of the procedure, with a 6F femoral sheath.

Full description

Percutaneous femoral access is the preferred access route for transcatheter aortic valve replacement (TAVR). The majority of experienced TAVR centers use two 6F Perclose ProGlide™ devices to close the primary vascular access site, deployed prior to upsizing sheath size with closure completed at the end of the case (the double "preclose" approach). A strategy of utilizing a single Perclose device to preclose may have advantages including fewer complications, complexity, and cost, but the safety of this is unknown. This study examines in the safety and efficacy of using a single Perclose escalation technique (SPET) using a single Perclose Proglide device to preclose and the need for a rescue device based on a control angiography at the end of the procedure, with a 6F femoral sheath. The use of Femoseal in mild bleedings, and a second Perclose Proglide for moderate to severe bleedings. Compare this SPET technique with double Preclose technique, with two historical cohorts of patients. One cohort of patients with SPET technique since started this technique, and a second cohort with double perclose technique prior to starting SPET technique.

Enrollment: 300 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients older than 18 years
• Patients who have undergone Transfemoral TAVI implantation

Exclusion criteria

• Patients who do not meet the inclusion criteria

Trial design

300 participants in 2 patient groups

Patients treated with one Perclose Proglide

Description:

Patients undergoing transfemoral TAVI implantation treated with one Perclose Proglide Suture

Treatment:

Device: One Perclose Proglide Suture

Patients treated with two Perclose Proglide Suture

Description:

Patients undergoing transfemoral TAVI implantation treated with two Perclose Proglide Suture

Treatment:

Device: Two Perclose Proglide Suture