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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04200378

Enrollment

Registered

2019-12-16

Start date

2020-08-20

Completion date

2024-04-11

Last updated

2024-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mitral Regurgitation

Brief summary

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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)

Countries

United States

Outcome results