Single Perclose Escalation Technique for Vascular Closure in TAVR

Not yet recruiting

• Conditions: Structural Valve Degeneration; Aortic Valve Stenosis; Structural Valve Deterioration
• Interventions: Device: One Perclose Proglide Suture; Device: Two Perclose Proglide Suture

• Registration Number: NCT05836311
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2023-04
• Study First Submitted: 2023-04-13
• Study First Submitted QC: 2023-04-26
• Study First Posted: 2023-05-01
• Last Update Submitted: 2023-05-02
• Last Update Posted: 2023-05-03
• Study Start: 2023-07-19
• Primary Completion: 2025-02-19
• Study Completion: 2025-02-19

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

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

Exclusion Criteria

• Patients who do not meet the inclusion criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients treated with one Perclose Proglide	One Perclose Proglide Suture	Patients undergoing transfemoral TAVI implantation treated with one Perclose Proglide Suture
Patients treated with two Perclose Proglide Suture	Two Perclose Proglide Suture	Patients undergoing transfemoral TAVI implantation treated with two Perclose Proglide Suture

Primary Outcome Measures

Name	Time	Method
SAFETY:Incidence of Intrahospital Major Vascular Complications and Bleeding type 2 or type >2 (according to VARC 3 criteria)	30 days	Intrahospital Major Vascular Complications and Bleeding type 2 or type \>2 (according to VARC 3 criteria)
EFFICACY:Incidence of successful femoral closure	30 days	Complete hemostasis at the puncture site with manual compression after the initial perclosure strategy

Secondary Outcome Measures

Name	Time	Method
Incidence of vascular complications (according to VARC3 criteria)	30 days	Incidence of vascular complications (according to VARC3 criteria)
All-cause Mortality	1 year	All-cause Mortality 1 year after procedure
Cost-effectiveness evaluation	30 days	Cost-effectiveness evaluation between two techniques
Incidence of bleeding (according to VARC3 criteria)	30 days	Incidence of bleeding (according to VARC3 criteria)

Trial Locations

Locations (1)

Hospital Universitari Vall D'Hebron; 🇪🇸 Barcelona, Spain