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

Completed

• Conditions: Mitral Regurgitation

• Registration Number: NCT04200378
• Lead Sponsor: Mayo Clinic

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-13
• Study First Submitted QC: 2019-12-13
• Study First Posted: 2019-12-16
• Study Start: 2020-08-20
• Primary Completion: 2023-02-13
• Study Completion: 2024-04-11
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-21
• Last Update Posted: 2024-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in stroke volume index	Baseline, approximately 10 mins after valve repair	Change in stroke volume index 10 minutes post repair to baseline stroke volume index measurement (L/m\^2)
Change in cardiac index	Baseline, approximately 10 mins after valve repair	Change in cardiac index 10 minutes post repair to baseline cardiac index measurement (L/min/m\^2)

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States