Health TrialsbyHealthPanel

Comparative Imaging Assessment of Valvular Heart Disease

ConditionsValve Heart DiseaseAortic StenosisAortic Regurgitation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorThe Cleveland Clinic

About this trial

The purpose of the study is to compare the various 2D and 3D methods of valvular heart disease quantification (Doppler, PISA, VCA, volumetric method) and strain with cardiac magnetic resonance (CMR) measurements of left and right ventricular systolic function strain and myocardial fibrosis assessment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-90 years of age

Suspected moderate or severe MR,AR or AS on the basis of prior known clinical history or clinical exam.

Suspected CRT "non-responder" with an implanted MRI compatible CRT device and reduced ejection fraction

Disqualifiers

Acute traumatic cardiac injury

Aortic dissection or aortic root rupture

Congenital heart diseases such as patent ductus arteriosus, coarctation of aorta, ASD and VSD

Presence of A-V fistula or intracardiac shunts

Trial population

Patients with suspected chronic AS, AR, MR or heart failure with reduced ejection fraction being evaluated for CRT implantation referred for clinically indicated CMR and echocardiography by their cardiologists.. CMR and echocardiography will be clinically indicated in this study group.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • MRI with strain measurement

    Diagnostic test

    CMR measurements of left and right ventricular systolic function strain and myocardial fibrosis

  • Echocardiography

    Diagnostic test

    Doppler, PISA, VCA, volumetric method as performed during echocardiography

Treatment groups

200 Participants
are divided into 4 treatment groups
Group A: Mitral Valve Regurgitation2 interventions
Group B: Aortic Valve Regurgitation2 interventions
Group C: Aortic Stenosis2 interventions
Group D: Patients referred for CRT Implantation2 interventions

Trial outcomes

Primary outcomes

1

Change in MRI Quantified LVEDVi

10% Change from Baseline - units of measure cc/m2

Time frame
6 months
2

Change in MRI Quantified LVESVi

15% Change from Baseline - units of measure cc/m2

Time frame
6 months
3

Change in MRI Quantified LV Strain

5% Change from Baseline

Time frame
6 months
4

Change in MRI LVEF

5% Change from Baseline

Time frame
6 Months

Secondary outcomes

1

Accuracy of echocardiography as compared with MRI

Comparison of MRI measurements based on standard of care echocardiography.

Time frame
6 Months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Cleveland Clinic

Lead sponsor

Source ClinicalTrials.gov
Apply now