NCT02005640

Brief Summary

The objective of this study is to evaluate the effect of annular sizing strategy (MDCT versus TEE) in transcatheter aortic valve implantation on the prevalence and severity of paravalvular regurgitation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2011

Shorter than P25 for all trials

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

December 1, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 3, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 9, 2013

Completed
Last Updated

March 19, 2015

Status Verified

March 1, 2015

Enrollment Period

9 months

First QC Date

December 3, 2013

Last Update Submit

March 18, 2015

Conditions

Aortic Stenosis

Outcome Measures

Primary Outcomes (3)

  • Rate of no/ mild paravalvular leakage before and after introduction of routing preoperative MSCT

    1 week to 3 months post-TAVI

  • MSCT vs. echocardiographic aortic valve sizing before TAVI

    time of TAVI

  • THV size before and after introduction of routing preoperative MSCT

    time of TAVI

Study Arms (2)

MSCT-based prothesis sizing

Echocardiographic-based prothesis sizing

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Primary analysis will be done in patients with a successful THV implantation and availability of high quality echocardiographic assessment and in the post routing MSCT group on the availability of a high quality MSCT scan.

You may qualify if:

  • Patients implanted with a THV at Aarhus University Hospital

You may not qualify if:

  • Learning curve patients (the first 40 patients implanted with a THV device at Aarhus University Hospital, Skejby).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiology and Cardiothoracic Surgery, Aarhus University Hospital

Aarhus N, 8000, Denmark

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 3, 2013

First Posted

December 9, 2013

Study Start

December 1, 2011

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

March 19, 2015

Record last verified: 2015-03

Locations

DK(1)