Health TrialsbyHealthPanel

A Study Of Clinical Implications Of Pulmonary Vascular Disease In Valvular Heart Disease

ConditionsPulmonary Vascular DiseaseValvular Heart Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥18 years old; AND

Scheduled for valve procedures

Disqualifiers

Congenital heart disease (except for bicuspid aortic valve), OR

Carcinoid heart disease, OR

Valvular mass, OR

Endocarditis, OR

Trial population

The study population will consist of patients scheduled to undergo transcatheter aortic, mitral, or tricuspid valve interventions at Mayo Clinic Rochester.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Echocardiogram

    Diagnostic test

    An echocardiogram will be performed during the patient's routinely scheduled right heart catheterization.

Treatment groups

600 Participants
are divided into 3 treatment groups
Group A: Aortic Intervention1 intervention
Group B: Mitral Intervention1 intervention
Group C: Tricuspid intervention1 intervention

Trial outcomes

Primary outcomes

1

Tricuspid Regurgitation (TR) reduction

Tricuspid Regurgitation (TR) reduction will be defined as ≥1 grade reduction

Time frame
Baseline, 12 months
2

Right Ventricular function improvement

Right Ventricular function improvement will be defined as ≥5% in Right Ventricular free wall longitudinal strain

Time frame
Baseline, 12 months

Secondary outcomes

1

Number of Hospitalizations

Number of Hospitalizations will be determined by the number of patients admitted to the hospital post procedure

Time frame
12 months
2

Number of Deaths

Number of Death will be determined by the number of patients that pass away post procedure due to any cause

Time frame
12 months
3

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.

Time frame
Baseline, 6 months, and 12 months
4

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.

Time frame
Baseline

Other outcomes

Sponsors and contacts

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

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov
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