Single Perclose Escalation Technique for Vascular Closure in TAVR

Aortic Valve Stenosis Clinical Trial

Official title:

Single Perclose Escalation Technique for Vascular Closure in TAVR

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05836311
• Other study ID #: CLOSURE TAVI 1 VERSUS 2
• Status: Not yet recruiting
• Start date: July 19, 2023
• Est. completion date: February 19, 2025

Study information

• Verified date: April 2023
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: VICENTE SERRA GARCIA, MD, PhD
• Phone: 0034932746155
• Email: vctsrr[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: February 19, 2025
• Est. primary completion date: February 19, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients older than 18 years

• Patients who have undergone Transfemoral TAVI implantation

Exclusion Criteria:

• Patients who do not meet the inclusion criteria

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Structural Valve Degeneration

Intervention

Device:
• One Perclose Proglide Suture
One Perclose Proglide Suture
• Two Perclose Proglide Suture
One Perclose Proglide Suture

Locations

Country	Name	City	State
Spain	Hospital Universitari Vall D'Hebron	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SAFETY:Incidence of Intrahospital Major Vascular Complications and Bleeding type 2 or type >2 (according to VARC 3 criteria)	Intrahospital Major Vascular Complications and Bleeding type 2 or type >2 (according to VARC 3 criteria)	30 days
Primary	EFFICACY:Incidence of successful femoral closure	Complete hemostasis at the puncture site with manual compression after the initial perclosure strategy	30 days
Secondary	Cost-effectiveness evaluation	Cost-effectiveness evaluation between two techniques	30 days
Secondary	Incidence of vascular complications (according to VARC3 criteria)	Incidence of vascular complications (according to VARC3 criteria)	30 days
Secondary	Incidence of bleeding (according to VARC3 criteria)	Incidence of bleeding (according to VARC3 criteria)	30 days
Secondary	All-cause Mortality	All-cause Mortality 30 days after procedure	30 days
Secondary	All-cause Mortality	All-cause Mortality 1 year after procedure	1 year