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NCT05332184 Clinical Trial

Cardiac T1 Mapping Enables Risk Prediction of LV Dysfunction After Surgery for Aortic Regurgitation

Aortic Regurgitation Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05332184
Other study ID # BAV_T1
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 1, 2016
Est. completion date March 13, 2020

Study information
Verified date April 2022
Source Universitätsklinikum Hamburg-Eppendorf
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To assess whether cardiac T1 mapping for detection of myocardial fibrosis enables preoperative identification of patients at risk for early left ventricular dysfunction after surgery of aortic regurgitation.

Description:

We hypothesized that a diffuse interstitial myocardial fibrosis may be present in AR patients who experience early systolic LV dysfunction after aortic valve surgery. We aimed to evaluate the association between preoperative cardiac T1 mapping for detection of myocardial fibrosis and early systolic LV dysfunction after surgery for aortic regurgitation.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date March 13, 2020
Est. primary completion date August 29, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Consecutive patients with severe aortic regurgitation referred for aortic valve surgery were prospectively enrolled in the study. Exclusion Criteria: - history of coronary artery disease - acute aortic valve disease (i.e., type A aortic dissection or infectious endocarditis) - common contraindications for MRI such as severe obesity and metallic foreign bodies.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• aortic valve surgery

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Universitätsklinikum Hamburg-Eppendorf

Outcome
Type Measure Description Time frame Safety issue
Primary Native T1 Measured with MRI baseline (Prior surgery)
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