Recruiting

Valvular Heart Disease

Sponsor:

The Cleveland Clinic

Code:

NCT04126018

Conditions

Valve Heart Disease

Aortic Stenosis

Aortic Regurgitation

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

MRI with strain measurement

Echocardiography

Study Details

Brief summary:

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.

Conditions

Valve Heart Disease

Aortic Stenosis

Aortic Regurgitation

Study ID

NCT04126018

Start date

Aug 23, 2019

Status verified date

Jan, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Any contraindications to CMR
  • Moderate or severe dysfunction in multiple valves
  • Patients with significant claustrophobia

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

Mitral Valve Regurgitation

Patients with moderate or severe (3+ or 4+) mitral valve regurgitation on the basis of prior known clinical history or clinical exam.

Aortic Valve Regurgitation

Patients with moderate or severe (3+ or 4+) aortic valve regurgitation on the basis of prior known clinical history or clinical exam.

Aortic Stenosis

Patients with moderate or severe (3+ or 4+) aortic stenosis on the basis of prior known clinical history or clinical exam.

Patients referred for CRT Implantation

Patients who meet clinical guideline criteria for CRT implantation with EF < 40%

Interventions

MRI with strain measurement

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

Echocardiography

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

Primary outcome measure

  • Change in MRI Quantified LVEDVi [ Time Frame: 6 months ]
  • Change in MRI Quantified LVESVi [ Time Frame: 6 months ]
  • Change in MRI Quantified LV Strain [ Time Frame: 6 months ]
  • Change in MRI LVEF [ Time Frame: 6 Months ]
  • Change in Kansas City Cardiomyopathy Questionnaire Answers [ Time Frame: 6 Months ]
  • Change in Physical Activity Questionnaire Answers [ Time Frame: 6 Months ]
  • All-cause mortality [ Time Frame: 6 Months ]
  • Development of class I or IIa indication for valve surgery [ Time Frame: 6 Months ]

Central Contacts and Locations

Central contacts

Deborah Kwon, M. D.

216-444-8526kwond@ccf.org

Locations

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Deborah Kwon, M. D.

216-444-8526kwond@ccf.org

More Information

Sponsor

The Cleveland Clinic

Last update posted

Jan 13, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Cleveland Clinic on 2026-01-13.