Single Perclose Escalation Technique for Vascular Closure in TAVR

NCT ID: NCT05836311

Last Updated: 2023-05-03

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-07-19
• Study Completion Date: 2025-02-19

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.

Conditions

Aortic Valve Stenosis; Structural Valve Deterioration; Structural Valve Degeneration

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Study Groups

Patients treated with one Perclose Proglide

Patients undergoing transfemoral TAVI implantation treated with one Perclose Proglide Suture

One Perclose Proglide Suture

Intervention Type: DEVICE

One Perclose Proglide Suture

Patients treated with two Perclose Proglide Suture

Patients undergoing transfemoral TAVI implantation treated with two Perclose Proglide Suture

Two Perclose Proglide Suture

Intervention Type: DEVICE

One Perclose Proglide Suture

Interventions

One Perclose Proglide Suture

One Perclose Proglide Suture

Intervention Type: DEVICE

Two Perclose Proglide Suture

One Perclose Proglide Suture

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitari Vall d'Hebron Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Universitari Vall D'Hebron

Barcelona, , Spain

Countries

Spain

Central Contacts

VICENTE SERRA GARCIA, MD, PhD

Role: CONTACT

vctsrr@hotmail.com

0034932746155

BRUNO GARCIA DEL BLANCO, MD, PhD

Role: CONTACT

brunogb51@gmail.com

0034932746155

References

Kodama A, Yamamoto M, Shimura T, Kagase A, Koyama Y, Tada N, Takagi K, Araki M, Yamanaka F, Shirai S, Watanabe Y, Hayashida K. Comparative data of single versus double proglide vascular preclose technique after percutaneous transfemoral transcatheter aortic valve implantation from the optimized catheter valvular intervention (OCEAN-TAVI) japanese multicenter registry. Catheter Cardiovasc Interv. 2017 Sep 1;90(3):E55-E62. doi: 10.1002/ccd.26686. Epub 2016 Oct 27.

Reference Type: BACKGROUND

PMID: 27785881 (View on PubMed)

Bazarbashi N, Ahuja K, Gad MM, Sammour YM, Kaur M, Karrthik A, Saad AM, Khubber S, Dhaliwal K, Mick SL, Navia JL, Puri R, Reed GW, Krishnaswamy A, Kapadia SR. The utilization of single versus double Perclose devices for transfemoral aortic valve replacement access site closure: Insights from Cleveland Clinic Aortic Valve Center. Catheter Cardiovasc Interv. 2020 Aug;96(2):442-447. doi: 10.1002/ccd.28585. Epub 2019 Nov 12.

Reference Type: BACKGROUND

PMID: 31713996 (View on PubMed)

Other Identifiers

CLOSURE TAVI 1 VERSUS 2

Identifier Type: -

Identifier Source: org_study_id