Valve Leaflet Motion in Sutureless Bioprosthetic Aortic Valves

• Sponsor: Karolinska University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02671474
• Collaborator: Karolinska Institutet (Other)
• Enrollment: 47
• Location: 1
• Duration (Months): 4
• Patients Per Site Per Month: 11.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Aortic Valve Stenosis; Heart Valve Disease	Other: 4-dimensional volume-rendered computed tomography	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 47 participants
• Primary Purpose: Diagnostic
• Study Start Date: Jan 1, 2016
• Actual Primary Completion Date: Mar 1, 2016
• Actual Study Completion Date: May 1, 2016

Outcome Measures

Primary Outcome Measures

1. Reduced aortic valve leaflet motion [At CT performed once no less than 30 days and up to 10 years after aortic valve replacement]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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:

• Contraindication for CT with intravenous contrast injection

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Cardiothoracic Surgery and Anesthesiology, Karolinska University Hospital	Stockholm		Sweden

Sponsors and Collaborators

• Karolinska University Hospital
• Karolinska Institutet

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Magnus Dalén, MD, Karolinska University Hospital
• ClinicalTrials.gov Identifier: NCT02671474
• Other Study ID Numbers: Perceval thrombosis
• First Posted: Feb 2, 2016
• Last Update Posted: Jul 11, 2016
• Last Verified: Jul 1, 2016

• Additional relevant MeSH terms: Aortic Valve Stenosis; Heart Valve Diseases

Study Results

No Results Posted as of Jul 11, 2016