Clinical trial NCT06983938: 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
Official title: Randomized Trial Comparing Dual Perclose Vs Single Angioseal And Perclose in Patients Undergoing Transfemoral Transcatheter Aortic Valve Replacement
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Transcatheter Aortic Valve Replacement
Closure Technique
Keywords: Transcatheter aortic valve replacement
Perclose Proglide
Angioseal
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
First posted: 2025-05-21
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Detailed description: This is a prospective, randomized, parallel, open-label, single-center, non-inferiority study.

Approximately 90 patients undergoing Transcatheter Aortic Valve Replacement with femoral access will be randomized in a 1:1 fashion to receive femoral access closure using either dual Perclose Proglide or single Perclose Proglide and Angioseal for closure.

The primary end point of this study is the composite endpoint of main access-related bleeding ≥Type 2 and main access related major vascular complication. Secondary end points include periprocedural complications (such as acute vessel closure, leg embolization and perforation), procedural characteristics (total duration, fluoroscopy time, contrast volume, length of hospital stay), and cost of hospitalization. A routine follow-up visit assessment will be performed at 30 days in the valve clinic and the assessment will include: any clinical change, re-interventions, and peripheral pulse evaluation.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Main access-related bleeding and vascular complications
timeFrame: Periprocedural
Secondary outcomes:
measure: Periprocedural complications, procedural characteristics, hospitalization
timeFrame: Periprocedural through hospital discharge
Other outcomes:
Locations:
city: Plano
country: United States
facility: Baylor Scott & White The Heart Hospital - Plano
state: Texas
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.