Valve Leaflet Motion in Sutureless Bioprosthetic Aortic Valves

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02671474

Enrollment

Registered

2016-02-02

Start date

2016-01-31

Completion date

2016-05-31

Last updated

2016-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Valve Stenosis, Heart Valve Disease

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 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.

Interventions

OTHER4-dimensional volume-rendered computed tomography

Study design

Primary purpose

DIAGNOSTIC

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

* Contraindication for CT with intravenous contrast injection

Design outcomes

Primary

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

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026