Invasive Hemodynamic Response to Transcatheter Edge-to-Edge Mitral Valve Repair

Mayo Clinic

Status: Completed

Conditions: Mitral Regurgitation

Study type: Observational

Funder types: Other

Identifiers

NCT04200378

19-004449

Details and patient eligibility

About

Studying the effects of Trans-catheter Mitral Valve Repair (TMVr) on the hemodynamics and biomarkers in patients with severe mitral valve regurgitation.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults (age ≥ 18 years) with severe, symptomatic primary mitral regurgitation identified by Doppler transthoracic echocardiogram
• Heart team (cardiologist and cardiac surgeon) agree that patient would be eligible for TMVR with Transcatheter edge to edge repair device.
• TMVR procedure will be performed in the cardiac catheterization laboratory for hemodynamic data recording

Exclusion criteria

• Women who are pregnant or believe they could be pregnant

Trial design

22 participants in 1 patient group

Subjects undergoing TMVr

Description:

Subjects with severe, symptomatic primary mitral regurgitation (MR) scheduled to undergo a transcatheter mitral valve repair (TMVr) as standard of care will have intra-op baseline and post repair blood draws. Pre-procedure and post-procedure transthoracic echocardiograms (TTE) will assess the hemodynamic implications of the repair.