NCT03753126

Brief Summary

A single-center prospective interventional trial. Patients implanted with a sutureless bioprosthetic aortic valve at Karolinska University Hospital in Stockholm, Sweden from 2012 will be eligible. 4-dimensional volume-rendered computed tomography (CT) of the heart will be performed. The aim of the CT is to assess valve geometry and hypo-atrenuated leaflet thickening. Results of the CT examination, preoperative clinical characteristics, and postoperative clinical data will be registered. Data will be collected prospectively and retrospectively. Informed consent will be obtained from patients meeting the inclusion criteria before the initiation of any study-specific procedures.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

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

Study Start

First participant enrolled

January 1, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

November 22, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 26, 2018

Completed
Last Updated

November 28, 2018

Status Verified

November 1, 2018

Enrollment Period

2.8 years

First QC Date

November 22, 2018

Last Update Submit

November 26, 2018

Conditions

Aortic Valve StenosisHeart Valve Diseases

Outcome Measures

Primary Outcomes (2)

  • Regional expansion of valve prosthesis

    Regional expansion measured using the angle formed by the border of each prosthetic leaflet and the centre point of the valve

    At CT performed once no less than 30 days and up to 10 years after aortic valve replacement

  • Overall expansion of valve prosthesis

    Overall expansion of the implanted prosthesis calculated as the ratio between the ex vivo cross-sectional area and the in vitro cross-sectional area of the implanted valve

    At CT performed once no less than 30 days and up to 10 years after aortic valve replacement

Secondary Outcomes (1)

  • Eccentricity of valve prosthesis

    At CT performed once no less than 30 days and up to 10 years after aortic valve replacement

Study Arms (1)

Cardiac CT imaging

OTHER
Radiation: 4-dimensional volume-rendered computed tomography

Interventions

4-dimensional volume-rendered computed tomographyRADIATION
Cardiac CT imaging

Eligibility Criteria

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

You may qualify if:

  • Implanted with a sutureless Perceval (LivaNova) sutureless bioprosthetic aortic valve at Karolinska University Hospital in Stockholm, Sweden between 2012 and 2016
  • Provide written informed consent

You may not qualify if:

  • Contraindication for CT with intravenous contrast injection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska University Hospital

Stockholm, Sweden

Location

Related Publications (1)

  • Themudo R, Kastengren M, Bacsovics Brolin E, Cederlund K, Svensson A, Dalen M. Leaflet thickening and stent geometry in sutureless bioprosthetic aortic valves. Heart Vessels. 2020 Jun;35(6):868-875. doi: 10.1007/s00380-020-01553-9. Epub 2020 Jan 16.

    PMID: 31950251DERIVED

MeSH Terms

Conditions

Aortic Valve StenosisHeart Valve Diseases

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Officials

  • Magnus Dalén, MD PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

November 22, 2018

First Posted

November 26, 2018

Study Start

January 1, 2016

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

November 28, 2018

Record last verified: 2018-11

Locations

SE(1)