NCT05332184

Brief 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2016

Typical duration for all trials

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

July 1, 2016

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2020

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

April 11, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 18, 2022

Completed
Last Updated

April 18, 2022

Status Verified

April 1, 2022

Enrollment Period

3.2 years

First QC Date

April 11, 2022

Last Update Submit

April 15, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Native T1

    Measured with MRI

    baseline (Prior surgery)

Study Arms (1)

Patients prior to aortic valve surgery

Procedure: aortic valve surgery

Interventions

Patients prior to aortic valve surgery

Eligibility Criteria

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

A total of 40 consecutive AR patients referred for aortic valve surgery were included.

You may qualify if:

  • Consecutive patients with severe aortic regurgitation referred for aortic valve surgery were prospectively enrolled in the study.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Aortic Valve Insufficiency

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

April 11, 2022

First Posted

April 18, 2022

Study Start

July 1, 2016

Primary Completion

August 29, 2019

Study Completion

March 13, 2020

Last Updated

April 18, 2022

Record last verified: 2022-04