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Status unknownNCT04392492Updated Dec 2, 2020

Vascular Closure Device in Transcatheter Aortic Valve Replacement

An observational study in Aortic Valve Stenosis, sponsored by Karolinska University Hospital. Status unknown at 1 site in Sweden. Per ClinicalTrials.gov, last updated 2020-12-02.

Sponsored by Karolinska University Hospital · Observational

The sponsor has not verified this record recently (last verified Nov 2020), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Sex
All
01

Study summary

Evaluation of the safety and efficacy of a percutaneous plug-based large-bore vascular closure device for femoral artery closure in an unselected consecutive patient cohort undergoing transcatheter aortic valve implantation in a single-center prospective study.

02

Conditions studied

  • Aortic Valve Stenosis

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03

In context

Aortic Valve Stenosis

985 studies on the registry are indexed under Aortic Valve Stenosis; 282 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 200 across 424 observational studies indexed under Aortic Valve Stenosis.

Browse Aortic Valve Stenosis studies →

Lead sponsor

Karolinska University Hospital is the lead sponsor of 275 studies on the registry; 54 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Consecutive patients undergoing TAVI at the Karolinska University Hospital

Inclusion criteria

  • Patients undergoing transfemoral TAVI at the Karolinska University Hospital

Exclusion criteria

Exclusion Criteria:

  • Patients undergoing TAVI with access other than transfemoral
  • Use of closure device other than MANTA
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Target follow-up
6 Weeks
Patient registry
Yes

Groups and cohorts

  • Patients undergoing transfemoral TAVI with MANTA closure

    Patients undergoing transfemoral transcatheter aortic valve replacement with femoral access site closure using the novel plug-based vascular closure device (MANTA, Teleflex/Essential Medical Inc., Malvern, Pennsylvania, USA).

    Device: MANTA vascular closure device

Interventions

  • DeviceMANTA vascular closure device

    Femoral access site closure using the MANTA closure device

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What researchers measure

Primary outcomes

  1. Number of patients with major vascular complications

    Major vascular access site complications according to the VARC-2 definitions

    Time frame: 6 week follow up

Secondary outcomes

  1. Number of patients with minor vascular complications

    Minor vascular access site complications according to the VARC-2 definitions

    Time frame: 6 week follow up

  2. Number of patients with vascular closure device failure

    Percutaneous vascular closure device failure according to the VARC-2 definitions

    Time frame: 6 week follow up

  3. Number of patients with life-threatening, disabling or major bleeding

    Life-threatening, disabling or major bleeding complications according to the BARC definitions

    Time frame: 6 week follow up

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Study locations

1 site
  • Department of Cardiology, Karolinska University Hospital
    Stockholm, Sweden
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References and documents

Publications

  • Kastengren M, Settergren M, Ruck A, Feldt K, Saleh N, Linder R, Verouhis D, Meduri CU, Bager J, Dalen M. Percutaneous plug-based vascular closure device in 1000 consecutive transfemoral transcatheter aortic valve implantations. Int J Cardiol. 2022 Jul 15;359:7-13. doi: 10.1016/j.ijcard.2022.04.033. Epub 2022 Apr 12. PubMed 35427700 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 2, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04392492
Lead sponsor
Karolinska University Hospital
Responsible party
Magnus Dalén (Associate professor, Karolinska University Hospital) — Principal investigator
First posted
May 18, 2020
Start date
Jan 25, 2017
Primary completion
Dec 31, 2020 (estimated)
Completion
Jan 31, 2021 (estimated)
Last update
Dec 2, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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