Recruiting

Observational Study

Sponsor:

Mayo Clinic

Code:

NCT07483203

Conditions

Pulmonary Vascular Disease

Valvular Heart Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Echocardiogram

Study Details

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

Study ID

NCT07483203

Start date

Apr 28, 2026

Status verified date

Jun, 2026

Completion date

May, 2028

Anticipated

Primary completion date

May, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Design

Enrollment

600 participants

Anticipated

Interventions and Outcome Measures

Arms

Aortic Intervention

Mitral Intervention

Tricuspid intervention

Interventions

Echocardiogram

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

Primary outcome measure

  • Tricuspid Regurgitation (TR) reduction [ Time Frame: Baseline, 12 months ]
  • Right Ventricular function improvement [ Time Frame: Baseline, 12 months ]

Central Contacts and Locations

Central contacts

Annabelle Fuenffinger

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

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Dr. Borlaug's Research Team

(507) 255-2200

Barry Borlaug, MD

(507) 255-1051Borlaug.Barry@mayo.edu

Principal Investigator:

Barry Borlaug, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Jun 18, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-06-18.