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

NCT07483203 | Not Yet Recruiting

• 1 other identifier: 26-000174
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Vascular Disease; Valvular Heart Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Number of Hospitalizations

  12 months

• Number of Deaths

  12 months

• Kansas City Cardiomyopathy Questionnaire (KCCQ)

  Baseline, 6 months, and 12 months

• Right atrial area change

  Baseline

• Tricuspid annular plane systolic excursion (TAPSE)

  Baseline

Study Arms (3)

Aortic Intervention

Diagnostic Test: Echocardiogram

Mitral Intervention

Diagnostic Test: Echocardiogram

Tricuspid intervention

Diagnostic Test: Echocardiogram

Interventions

Echocardiogram DIAGNOSTIC_TEST

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

Aortic Intervention; Mitral Intervention; Tricuspid intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• ≥18 years old; AND
• Scheduled for valve procedures

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Heart Valve Diseases

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Barry Borlaug, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Annabelle Fuenffinger

CONTACT

507-422-3801; fuenffinger.annabelle@mayo.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 19, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)