NCT04459208

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
516

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

June 26, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 7, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 7, 2021

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 4, 2021

Completed
Last Updated

September 29, 2021

Status Verified

September 1, 2021

Enrollment Period

1 year

First QC Date

June 26, 2020

Last Update Submit

September 28, 2021

Conditions

Aortic Valve Stenosis

Keywords

Vascular access site closureTranscatheter aortic valve implantationVascular closure deviceVascular access-site injury

Outcome Measures

Primary Outcomes (1)

  • Rate of in-hospital access-site or access-related vascular injury according to the VARC-2 definition

    Rate of in-hospital access-site or access-related vascular injury according to the VARC-2 definition

    up to 7 days

Secondary Outcomes (18)

  • Rate of access-site or access-related vascular injury

    30 days

  • Rate of major access-site or access-related vascular injury

    up to 7 days and at 30 days

  • Rate of minor access site or access-related vascular injury

    up to 7 days and at 30 days

  • Rate of access-site or access-related vascular injury, access-site or access-related bleeding and VCD failure according to VARC-2 criteria

    up to 7 days and at 30 days)

  • all-cause death

    up to 7 days and 30-day

  • +13 more secondary outcomes

Study Arms (2)

Manta

ACTIVE COMPARATOR

plug-based vascular closure

Device: Manta

ProGlide

ACTIVE COMPARATOR

suture-based vascular closure

Device: ProGlide

Interventions

MantaDEVICE

plug-based vascular closure

Manta
ProGlideDEVICE

suture-based vascular closure

ProGlide

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herzzentrum Leipzig

Leipzig, Germany

Location

Related Publications (1)

  • Abdel-Wahab M, Hartung P, Dumpies O, Obradovic D, Wilde J, Majunke N, Boekstegers P, Muller R, Seyfarth M, Vorpahl M, Kiefer P, Noack T, Leontyev S, Sandri M, Rotta Detto Loria J, Kitamura M, Borger MA, Funkat AK, Hohenstein S, Desch S, Holzhey D, Thiele H; CHOICE-CLOSURE Investigators. Comparison of a Pure Plug-Based Versus a Primary Suture-Based Vascular Closure Device Strategy for Transfemoral Transcatheter Aortic Valve Replacement: The CHOICE-CLOSURE Randomized Clinical Trial. Circulation. 2022 Jan 18;145(3):170-183. doi: 10.1161/CIRCULATIONAHA.121.057856. Epub 2021 Nov 5.

    PMID: 34738828DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Officials

  • Mohamed Abdel-Wahab, PD Dr.

    Herzzentrum Leipzig GmbH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Investigator-initiated, single-center, prospective, open-label randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2020

First Posted

July 7, 2020

Study Start

June 26, 2020

Primary Completion

July 7, 2021

Study Completion

August 4, 2021

Last Updated

September 29, 2021

Record last verified: 2021-09

Locations

DE(1)