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CompletedNCT02671474Updated Jul 11, 2016

Valve Leaflet Motion in Sutureless Bioprosthetic Aortic Valves

An interventional study of 4-dimensional volume-rendered computed tomography in Aortic Valve Stenosis and Heart Valve Disease, sponsored by Karolinska University Hospital. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-07-11.

Sponsored by Karolinska University Hospital · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
47
Ages
18 Years and older
Sex
All
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Study 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 leaflet motion. 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.

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Conditions studied

  • Aortic Valve Stenosis
  • Heart Valve Disease
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In context

Aortic Valve Stenosis

985 studies on the registry are indexed under Aortic Valve Stenosis; 283 are open to participants now.

This study's enrollment of 47 is below the median of 120 across 525 interventional 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
18 Years and older
Sexes eligible
All

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Contraindication for CT with intravenous contrast injection
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Enrollment
47 participants (actual)

Interventions

  • Other4-dimensional volume-rendered computed tomography
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What researchers measure

Primary outcomes

  1. Reduced aortic valve leaflet motion

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

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Study locations

1 site
  • Department of Cardiothoracic Surgery and Anesthesiology, Karolinska University Hospital
    Stockholm, Sweden
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References and documents

Publications

  • Dalen M, Sartipy U, Cederlund K, Franco-Cereceda A, Svensson A, Themudo R, Svenarud P, Bacsovics Brolin E. Hypo-Attenuated Leaflet Thickening and Reduced Leaflet Motion in Sutureless Bioprosthetic Aortic Valves. J Am Heart Assoc. 2017 Aug 21;6(8):e005251. doi: 10.1161/JAHA.116.005251. PubMed 28862959 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 11, 2016, 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
NCT02671474
Lead sponsor
Karolinska University Hospital
Collaborators
Karolinska Institutet
Responsible party
Magnus Dalén (MD, Karolinska University Hospital) — Principal investigator
First posted
Feb 2, 2016
Start date
Jan 2016
Primary completion
Mar 2016
Completion
May 2016
Last update
Jul 11, 2016
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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