Use of Cardiac-MRI to Predict Results for People With Severe Aortic Stenosis

Withdrawn

• Conditions: Aortic Valve Stenosis

• Registration Number: NCT01905852
• Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Brief Summary

Background:

- Aortic valve stenosis is a disease that makes a major heart valve get smaller. This reduces heart function and causes death. Severe aortic stenosis (AS) can be treated in a couple of ways, including replacing a heart valve.

Objectives:

Researchers want to study fibrosis in the heart. A sub-study will test whether heart function and blood supply improve after a valve replacement.

Eligibility:

- Adults at least 18 years old with aortic stenosis.

Design:

* Participants will visit a clinic for 1 day for magnetic resonance imaging (MRI) of their heart. This uses magnets, radio waves, and computers to produce detailed pictures of the heart.

* After this visit, participants will have their aortic valve procedure at the the Washington Hospital Center. A hospital team will contact participants for 1 year by phone or email. This follow-up will consist of 15 minutes of questions about the participant s health status.

* Some participants will join a sub-study.

* They will be given an additional medication to evaluate the blood supply of the heart.

* They will visit a clinic for 1 day for an MRI of their heart, as part of the main study, prior to the aortic valve replacement.

* After they have their valve replaced at the hospital, they will return to the clinic for another MRI.

* They will have the same follow-up as in the main study.

Detailed Description

Aortic valve stenosis is a disease that causes narrowing of a major heart valve, and that reduces heart function and causes death. The purpose of this protocol is to use magnetic resonance imaging of the heart to identify which patients would benefit from replacement of the diseased valve.

Study Timeline

• Study Start: 2013-06-27
• Study First Submitted: 2013-07-18
• Study First Submitted QC: 2013-07-18
• Study First Posted: 2013-07-23
• Status Verified: 2014-04-08
• Primary Completion: 2016-12-31
• Study Completion: 2016-12-31
• Last Update Submitted: 2019-09-12
• Last Update Posted: 2019-09-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the ability of cardiac MRI measurement of extracellular volume fraction (related to myocardial fibrosis) to predict short and long term LV function of subjects with severe aortic stenosis undergoing transcatheter AVR.	3 years