This Study Will Evaluate the Safety and Potential Complications of Dual ProGlide vs Single ProGlide and Angioseal for Common Femoral Arteriotomy Closure Following Transcatheter Aortic Valve Replacement

NCT06983938 | Completed Results FDA Device

• 1 other identifier: 024-458
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, randomized, parallel, single-center, open-label, non-inferiority study will evaluate the safety and potential complications of dual ProGlide vs single ProGlide and Angioseal for common femoral arteriotomy closure following Transcatheter Aortic Valve Replacement.

Conditions

Closure Technique; Transcatheter Aortic Valve Replacement

Keywords

Transcatheter aortic valve replacement; Perclose Proglide; Angioseal

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Main Access-related Bleeding and Vascular Complications

  Primary endpoint collected will be the number of participants with the composite endpoint of main access-related bleeding ≥Type 2 and main access related major vascular complication- VARC (Valve Academic Research Consortium) 3 Criteria.

  Periprocedural through hospital discharge, an average of 1.5 days

Secondary Outcomes (1)

• The Number of Participants With Periprocedural Complications, What the Procedural Characteristics Are, and Hospitalization.

  Periprocedural through hospital discharge, an average of 1.5 days

Study Arms (2)

Dual Perclose Proglide

ACTIVE COMPARATOR

Upon completion of valve replacement, this cohort will be closed using dual Perclose Proglide devices.

Device: Double Perclose Proglide

Single Perclose Proglide plus Angioseal

ACTIVE COMPARATOR

Upon completion of valve replacement, this cohort will be closed using a single Perclose Proglide device and single Angioseal device.

Device: Single Perclose Proglide plus Angioseal

Interventions

Double Perclose Proglide DEVICE

Upon completion of valve replacement, closure will proceed using two Perclose Proglide devices.

Dual Perclose Proglide

Single Perclose Proglide plus Angioseal DEVICE

Upon completion of valve replacement, closure will proceed using one Perclose Proglide device plus one Angioseal device.

Single Perclose Proglide plus Angioseal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old
• Planned to undergo transcatheter aortic valve replacement via femoral access
• Able to provide written informed consent prior to study participation

You may not qualify if:

• Non-femoral access
• Previous repair or intervention of the common femoral artery
• Previous pseudoaneurysm of the common femoral artery
• Children below 18 years, prisoners, and patients who are unable to provide consent are excluded.
• In another research study that has not granted permission to dual-enroll.

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (1)

Baylor Scott & White The Heart Hospital - Plano

Plano, Texas, 75093, United States

Location

Related Publications (3)

• Kiramijyan S, Magalhaes MA, Ben-Dor I, Koifman E, Escarcega RO, Baker NC, Torguson R, Okubagzi P, Bernardo NL, Satler LF, Pichard AD, Waksman R. The adjunctive use of Angio-Seal in femoral vascular closure following percutaneous transcatheter aortic valve replacement. EuroIntervention. 2016 May 17;12(1):88-93. doi: 10.4244/EIJV12I1A16.

  PMID: 27173868 BACKGROUND

• Ko TY, Kao HL, Liu YJ, Yeh CF, Huang CC, Chen YH, Hung CS, Chan CY, Lin LC, Chen YS, Lin MS. Intentional combination of ProGlide and Angio-Seal for femoral access haemostasis in transcatheter aortic valve replacement. Int J Cardiol. 2019 Oct 15;293:76-79. doi: 10.1016/j.ijcard.2019.05.055. Epub 2019 May 23.

  PMID: 31155328 BACKGROUND

• 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.

  PMID: 31713996 BACKGROUND

Results Point of Contact

• Title: Bonnie Ostergren
• Organization: Baylor Scott & White Research Institute

Bonnie.Ostergren@bswhealth.org

469-814-4181

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: May 21, 2025
• Study Start: February 12, 2025
• Primary Completion: August 13, 2025
• Study Completion: October 15, 2025
• Last Updated: March 16, 2026
• Results First Posted: March 16, 2026

Record last verified: 2025-09

Locations

US (1)