Single Perclose Escalation Technique for Vascular Closure in TAVR

• Sponsor: Hospital Universitari Vall d'Hebron Research Institute (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05836311
• Collaborator: (none)
• Enrollment: 300
• Location: 1
• Anticipated Duration (Months): 19.1
• Patients Per Site Per Month: 15.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Aortic Valve Stenosis; Structural Valve Deterioration; Structural Valve Degeneration	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 Design

• Study Type: Observational
• Anticipated Enrollment: 300 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• Official Title: Single Perclose Escalation Technique for Vascular Closure in TAVR
• Anticipated Study Start Date: Jul 19, 2023
• Anticipated Primary Completion Date: Feb 19, 2025
• Anticipated Study Completion Date: Feb 19, 2025

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. 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)

2. 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

1. Cost-effectiveness evaluation [30 days]

   Cost-effectiveness evaluation between two techniques

2. Incidence of vascular complications (according to VARC3 criteria) [30 days]

   Incidence of vascular complications (according to VARC3 criteria)

3. Incidence of bleeding (according to VARC3 criteria) [30 days]

   Incidence of bleeding (according to VARC3 criteria)

4. All-cause Mortality [30 days]

   All-cause Mortality 30 days after procedure

5. All-cause Mortality [1 year]

   All-cause Mortality 1 year after procedure

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients older than 18 years

• Patients who have undergone Transfemoral TAVI implantation

Exclusion Criteria:

• Patients who do not meet the inclusion criteria

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Universitari Vall D'Hebron	Barcelona		Spain	08035

Sponsors and Collaborators

• Hospital Universitari Vall d'Hebron Research Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.

• Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
• ClinicalTrials.gov Identifier: NCT05836311
• Other Study ID Numbers: CLOSURE TAVI 1 VERSUS 2
• First Posted: May 1, 2023
• Last Update Posted: May 3, 2023
• Last Verified: Apr 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Hospital Universitari Vall d'Hebron Research Institute: Residual Stenosis
• Additional relevant MeSH terms: Aortic Valve Stenosis

Study Results

No Results Posted as of May 3, 2023