NCT02671474

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

January 24, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 2, 2016

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

July 11, 2016

Status Verified

July 1, 2016

Enrollment Period

2 months

First QC Date

January 24, 2016

Last Update Submit

July 7, 2016

Conditions

Aortic Valve StenosisHeart Valve Disease

Outcome Measures

Primary Outcomes (1)

  • Reduced aortic valve leaflet motion

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

Interventions

4-dimensional volume-rendered computed tomographyOTHER

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Contraindication for CT with intravenous contrast injection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiothoracic Surgery and Anesthesiology, Karolinska University Hospital

Stockholm, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 28862959DERIVED

MeSH Terms

Conditions

Aortic Valve StenosisHeart Valve Diseases

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Design

Study Type
interventional
Phase
not applicable
Purpose
DIAGNOSTIC
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 24, 2016

First Posted

February 2, 2016

Study Start

January 1, 2016

Primary Completion

March 1, 2016

Study Completion

May 1, 2016

Last Updated

July 11, 2016

Record last verified: 2016-07

Locations

SE(1)