Valve Leaflet Motion in Sutureless Bioprosthetic Aortic Valves

Not Applicable

Completed

• Conditions: Aortic Valve Stenosis; Heart Valve Disease

• Registration Number: NCT02671474
• Lead Sponsor: Karolinska University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-01-24
• Study First Submitted QC: 2016-01-31
• Study First Posted: 2016-02-02
• Primary Completion: 2016-03
• Study Completion: 2016-05
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-07
• Last Update Posted: 2016-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Department of Cardiothoracic Surgery and Anesthesiology, Karolinska University Hospital; 🇸🇪 Stockholm, Sweden