Valve Leaflet Motion in Sutureless Bioprosthetic Aortic V... | NCT02671474

Studies
Valve Leaflet Motion in Sutureless Bioprosthetic Aortic Valves

NCT02671474

Sponsor

Karolinska University Hospital

Status

Completed

Last Update Posted

Jul 11, 2016Estimated

Enrollment

47Actual

Phase

Not Applicable

Conditions

Aortic Valve Stenosis
Heart Valve Disease

Interventions

4-dimensional volume-rendered computed tomography

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2016

Primary Completion Date

Mar 2016Actual

Completion Date

May 2016Actual

First Submitted Date

Jan 24, 2016

First Submission Date that Met QC Criteria

Jan 31, 2016

First Posted Date

Feb 2, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 7, 2016

Last Update Posted Date

Jul 11, 2016Estimated

Name	Class
Karolinska Institutet	OTHER

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

47Actual

Name	Type	Description	Arm Group Labels	Other Names
4-dimensional volume-rendered computed tomography	Other

Outcomes Module

Primary Outcomes

Measure	Description	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Cardiothoracic Surgery and Anesthesiology, Karolinska University Hospital		Stockholm			Sweden

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28862959	Derived	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.

ID	Term
D001024	Aortic Valve Stenosis
D006349	Heart Valve Diseases

ID	Term
D000082862	Aortic Valve Disease
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014694	Ventricular Outflow Obstruction