Single Perclose Escalation Technique for Vascular Closure in TAVR

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Aortic Valve Stenosis; Structural Valve Degeneration; Structural Valve Deterioration
• Intervention / Treatment: Device: One Perclose Proglide Suture; Device: Two Perclose Proglide Suture

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 Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: VICENTE SERRA GARCIA, MD, PhD; Phone Number: 0034932746155; Email: vctsrr@hotmail.com
• Study Contact Backup: Name: BRUNO GARCIA DEL BLANCO, MD, PhD; Phone Number: 0034932746155; Email: brunogb51@gmail.com

Study Locations

• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d'Hebron

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing transfemoral TAVI implantation in a single center

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients treated with one Perclose Proglide; Patients undergoing transfemoral TAVI implantation treated with one Perclose Proglide Suture	Device: One Perclose Proglide Suture; One Perclose Proglide Suture
Patients treated with two Perclose Proglide Suture; Patients undergoing transfemoral TAVI implantation treated with two Perclose Proglide Suture	Device: Two Perclose Proglide Suture; One Perclose Proglide Suture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
EFFICACY:Incidence of successful femoral closure	Complete hemostasis at the puncture site with manual compression after the initial perclosure strategy	30 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): July 19, 2023
• Primary Completion (Anticipated): February 19, 2025
• Study Completion (Anticipated): February 19, 2025

Study Registration Dates

• First Submitted: April 13, 2023
• First Submitted That Met QC Criteria: April 26, 2023
• First Posted (Actual): May 1, 2023

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: May 2, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Residual Stenosis
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: CLOSURE TAVI 1 VERSUS 2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No