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Clinical Trial NCT07483203 for Pulmonary Vascular Disease, Valvular Heart Disease is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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A Study Of Clinical Implications Of Pulmonary Vascular Disease In Valvular Heart Disease 600

Not yet recruiting
Clinical Trial NCT07483203 is an observational study for Pulmonary Vascular Disease, Valvular Heart Disease and is currently not yet recruiting. Enrollment is planned to begin on 1 May 2026 and continue until the study accrues 600 participants. Led by Mayo Clinic, this study is expected to complete by 1 May 2028. The latest data from ClinicalTrials.gov was last updated on 19 March 2026.
Brief Summary
The purpose of this study is to characterize pulmonary hemodynamic profiles, with a focus on PVR subtypes, in patients with left-sided valvular heart disease undergoing aortic or mitral valve intervention, and to identify patterns predicting reversibility of TR and RV dysfunction.
Official Title

Clinical Implications of Pulmonary Vascular Disease in Valvular Heart Disease

Conditions
Pulmonary Vascular DiseaseValvular Heart Disease
Other Study IDs
  • 26-000174
NCT ID Number
NCT07483203
Start Date (Actual)
2026-05
Last Update Posted
2026-03-19
Completion Date (Estimated)
2028-05
Enrollment (Estimated)
600
Study Type
Observational
Status
Not yet recruiting
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Aortic Intervention
Echocardiogram
An echocardiogram will be performed during the patient's routinely scheduled right heart catheterization.
Mitral Intervention
Echocardiogram
An echocardiogram will be performed during the patient's routinely scheduled right heart catheterization.
Tricuspid intervention
Echocardiogram
An echocardiogram will be performed during the patient's routinely scheduled right heart catheterization.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Tricuspid Regurgitation (TR) reduction
Tricuspid Regurgitation (TR) reduction will be defined as ≥1 grade reduction
Baseline, 12 months
Right Ventricular function improvement
Right Ventricular function improvement will be defined as ≥5% in Right Ventricular free wall longitudinal strain
Baseline, 12 months
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Number of Hospitalizations
Number of Hospitalizations will be determined by the number of patients admitted to the hospital post procedure
12 months
Number of Deaths
Number of Death will be determined by the number of patients that pass away post procedure due to any cause
12 months
Kansas City Cardiomyopathy Questionnaire (KCCQ)
KCCQ is a 12-item questionnaires that measure the participant's perception of their health status, including their heart failure (HF) symptoms, impact on physical and social function and how their HF impacts the quality of life. Scores were generated for each domain and scaled from 0 to 70, with 0 (worst) and 70 (the best possible status), where the higher score reflected better health status.
Baseline, 6 months, and 12 months
Right atrial area change
Right atrial area change is used to assess right vascular function. It will measure the area of change within the right ventricle between diastole and systole as a percentage.
Baseline
Tricuspid annular plane systolic excursion (TAPSE)
Tricuspid annular plane systolic excursion will be used to measure right ventricular function and measured in mm (millimeters)
Baseline
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • ≥18 years old; AND
  • Scheduled for valve procedures

  • Congenital heart disease (except for bicuspid aortic valve), OR
  • Carcinoid heart disease, OR
  • Valvular mass, OR
  • Endocarditis, OR
  • Any other condition that, in the opinion of the investigator, would impair their ability to complete the study
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Study Responsible Party
Barry Borlaug, Principal Investigator, Principal Investigator, Mayo Clinic
Study Central Contact
Contact: Annabelle Fuenffinger, 507-422-3801, [email protected]
1 Study Locations in 1 Countries

Minnesota

Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States