Non-Contrast Magnetic Resonance Angiography Assessment of Patients Referred for Transcatheter Aortic Valve Implantation

Aortic Valve Stenosis Clinical Trial

Official title:

Can Non-Contrast Magnetic Resonance Angiography Accurately Define Arterial Access and Aortic Root Anatomy in Patients Referred for Transcatheter Aortic Valve Implantation?

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02007967
• Other study ID #: HUM00070087
• Status: Terminated
• Phase: N/A
• First received: November 8, 2013
• Last updated: December 20, 2016
• Start date: December 2013
• Est. completion date: January 2014

Study information

• Verified date: December 2016
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aortic Valve Stenosis

Locations

Country	Name	City	State
United States	University of Michigan Cardiovascular Center	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Graded image quality	Compare graded image quality for ileofemoral arteries, aorta, and aortic annulus between MRI and CT	3 hours	No
Secondary	Annular size	Compare annular diameter, area, and perimeter between MRI and CT	3 hours	No