Comparison of Different Vascular Closure Device in TAVI

Not Applicable

• Conditions: Aortic Valve Stenosis; Transcatheter Aortic Valve Implantation
• Interventions: Device: Vascular closure device (Angio-Seal, Progilde)

• Registration Number: NCT05491070
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

Femoral artery approach for transcatheter aortic valve implantation (TAVI) is an ideal approach site. However the closure for femoral artery after transfemoral TAVI is challenging. We aimed to compared the efficacy and safety of Angio-Seal + Proglide vs. Dual Proglide for femoral arteriotomy closure following TAVI

Detailed Description

Aortic stenosis (AS) is a common, potentially fatal condition that emerges as a substantial public health burden. The prevalence of AS is as high as 9.8% in those 80 years or older, with an overall prevalence of 2.8% in adults over 75 years of age. Several studies have demonstrated that the overall risk of sudden death in asymptomatic patients with aortic stenosis is around 2%. Once symptoms develop, there is an inexorable deterioration with a poor prognosis. Within 3 years of the onset of angina, syncope, or the symptoms of heart failure, 75% of symptomatic patients are dead unless the outflow obstruction is relieved. Therefore, the modality to solve AS is life saving for this patient group. Before 2002 when first-in-man transcatheter aortic valve implantation (TAVI) was performed, surgical aortic valve replacement (SAVR) is the only treatment of choice for patients with severe symptomatic aortic stenosis. As TAVI prevailed, TAVI has been demonstrated to be safe and effective in relieving AS in patients with high and intermediate surgical risk. Transfemoral approach is preferential approach of TAVI. As the device evolved, transfemoral TAVI procedure is moving to local anaesthetic with percutaneous procedure instead of surgical cut-down.

Femoral arteriotomy closure following TAVI remains challenging and, at times, may result in significant or even fatal complications. Even though the evolution of device and smaller device size, complications associated with the femoral access site are reported in 5-20% of patients undergoing TAVI. The incidence of access site-related vascular complications reinforces the need for the improvement of techniques that ensure effective and reproducible hemostasis with a safe and effective arteriotomy closure. The Perclose ProGlide (PP) suture-mediated closure device (Abbott Vascular, Santa Clara, CA, USA) has been widely utilized in a dual pre-close strategy, and successful closures may be obtained for up to 24F sheath. Moreover, the preclose technique has been shown not to increase the risk of CFA narrowing. Therefore, the preclose technique has been widely used in percutaneous endovascular procedures using large diameter arteriotomies, including TAVI and EVAR.

Nevertheless, failure of this device requiring further intervention has been described in 4-9% of cases. Adjunctive Angio-Seal technique has been postulated as feasible and safe or even considered as a bail-out strategy when the dual PP closure technique fails to obtain complete hemostasis. Therefore, the best strategy for femoral arteriotomy closure following TAVI remains to be studied.

In our hospital, we have performed either dual PP or one Perclose ProGlide with one Angio-Seal for femoral arteriotomy closure following TAVI. Both have been shown to be satisfactory for complete hemostasis. However, there was not study regarding complete hemostasis, long-term vessel outcome and clinical walking ability between these two procedures. Herein, we design a open-labeled randomized study to compare the efficacy of complete hemostasis and long-term vascular outcome between dual PP and one Perclose ProGlide with one Angio-Seal following TAVI.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-03-20
• Study First Submitted: 2018-07-20
• Status Verified: 2022-08
• Study First Submitted QC: 2022-08-05
• Last Update Submitted: 2022-08-05
• Study First Posted: 2022-08-08
• Last Update Posted: 2022-08-08
• Primary Completion: 2022-10-30
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Age >= 20 years old
• Severe aortic stenosis and suitable candidate for transfemoral transcatheter aortic valve implantation

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Exclusion Criteria

• Age < 20 years old
• Severe aortic stenosis not suitable for transfemoral transcatheter aortic valve implantation

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Progilde + AngioSeal	Vascular closure device (Angio-Seal, Progilde)	Use Progilde + AngioSeal for closure of femoral artery with large sheath in transfemoral TAVI
Dual Proglide	Vascular closure device (Angio-Seal, Progilde)	Use Two Progilde for closure of femoral artery with large sheath in transfemoral TAVI

Primary Outcome Measures

Name	Time	Method
Vascular complication	during hospitalization for index procedure	TAVI related major or minor vascular complication according to valve academic research consortium 3 criteria
Life threatening bleeding complication	within 24hrs after the index procedure	TAVI related life threatening bleeding according valve academic research consortium 3 criteria
Major or minor bleeding complication without life threatening condition	within 24hrs after the index procedure	TAVI related major or minor bleeding according valve academic research consortium 3 without life threatening condition

Secondary Outcome Measures

Name	Time	Method
Bail-out closure device use	within 10mins after the index procedure	additional closure device deployment for femoral access site to achieve hemostasis
Limb ischemia related to TAVI	within one year after TAVI	Significant peripheral ischemia related to arteriotomy closure
In-hospital serious vascular complications requiring percutaneous or surgical interventions	In the index hospitalization (up to 14 days)	Vascular perforation or dissection, peripheral ischemia or acute limb ischemia, arteriovenous fistula, pseudoaneurysm, and access-site hematoma.

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan