Randomized Comparison of Catheter-based Strategies for Interventional Access Site Closure During Transfemoral Transcatheter Aortic Valve Implantation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

516 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-26

Study Completion Date

2021-08-04

Brief Summary

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The aim of the study is to evaluate the clinical efficacy of 2 different vascular closure device (VCD) strategies during transfemoral transcatheter aortic valve implantation (TAVI). The study hypothesizes that the choice of one over the other VCD in patients undergoing transfemoral TAVI may demonstrate relevant differences in the rate of peri-procedural complications and effectiveness of vascular closure.

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Detailed Description

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Use of a plug-based VCD in patients undergoing transfemoral TAVI as compared to a suture-based VCD.

Conditions

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Aortic Valve Stenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Investigator-initiated, single-center, prospective, open-label randomized controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Manta

plug-based vascular closure

Group Type ACTIVE_COMPARATOR

Manta

Intervention Type DEVICE

plug-based vascular closure

ProGlide

suture-based vascular closure

Group Type ACTIVE_COMPARATOR

ProGlide

Intervention Type DEVICE

suture-based vascular closure

Interventions

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Manta

plug-based vascular closure

Intervention Type DEVICE

ProGlide

suture-based vascular closure

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Patients with an indication for transfemoral TAVI as judged by the local heart team.
2. Transfemoral access route and a commercially-available transcatheter aortic valve is selected by the local heart team.
3. The patient is willing to provide written informed consent and comply with protocol- specified follow-up evaluations.

Exclusion Criteria

1. Vascular access site anatomy not suitable for percutaneous vascular closure.
2. Vascular access site complications prior to the TAVI procedure.
3. Known allergy or hypersensitivity to any VCD component.
4. Unstable active bleeding/ bleeding diathesis or significant unmanageable anemia.
5. Absence of computed tomographic data of the access site before the procedure.
6. Systemic infection or a local infection at or near the access site.
7. Life expectancy of less than 6 months due to non-cardiac conditions.
8. Patient cannot adhere to or complete the investigational protocol for any reason.
9. Pregnant or nursing subjects.
10. Participation in any other interventional trial.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No