Comparative Imaging Assessment of Valvular Heart Disease

RECRUITING

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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 Start (Actual) 23 August 2019

🗓️ Primary Completion (Estimated) 31 December 2025

✅ Study Completion (Estimated) 30 June 2026

👥 Enrollment (Estimated) 200

🔬 Study Type OBSERVATIONAL

📊 Phase N/A

Locations:

📍 Cleveland, Ohio, United States

📋 Eligibility Criteria

Description

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

Ages Eligible for Study: 18 Years to 90 Years (ADULT, OLDER_ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 20 August 2019
First Submitted that Met QC Criteria 11 October 2019
First Posted 14 October 2019

Study Record Updates

Last Update Submitted that Met QC Criteria 13 December 2023
Last Update Posted 19 December 2023
Last Verified December 2023