NCT02007967

Brief Summary

The overall objective of this proposal is to examine the feasibility and accuracy of non-contrast magnetic resonance angiography (MRA) to comprehensively evaluate individuals referred for transcatheter aortic valve implantation (TAVI).

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

November 8, 2013

Completed
23 days until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 11, 2013

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

December 22, 2016

Status Verified

December 1, 2016

Enrollment Period

1 month

First QC Date

November 8, 2013

Last Update Submit

December 20, 2016

Conditions

Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (1)

  • Minimal luminal size for aorta and ileofemoral arteries

    Compare luminal diameter for each segment of the ileofemoral arteries and aorta between MRI and CT

    3 hours

Secondary Outcomes (2)

  • Graded image quality

    3 hours

  • Annular size

    3 hours

Eligibility Criteria

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

Study population will include patients undergoing clinically indicated computed tomography angiography for evaluation for possible transcatheter aortic valve implantation.

You may qualify if:

  • Adults with severe aortic stenosis referred for possible transcatheter aortic valve implantation with clinically indicated computed tomography imaging

You may not qualify if:

  • Inability or unwillingness to consent
  • Inability to complete magnetic resonance imaging (MRI) study
  • Contraindication to MRI
  • Participation in another research study
  • Non-diagnostic computed tomography scan

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan Cardiovascular Center

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Officials

  • Troy M LaBounty, M.D.

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Internal Medicine

Study Record Dates

First Submitted

November 8, 2013

First Posted

December 11, 2013

Study Start

December 1, 2013

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

December 22, 2016

Record last verified: 2016-12

Locations

US(1)