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OpenTrials
Completed

NCT Number: NCT04200378

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

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

Completed

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Key information

Conditions

Mitral Regurgitation Cardiovascular Diseases Heart Diseases Heart Valve Diseases Mitral Valve Insufficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change in stroke volume index

    Time frame: 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)

  2. Change in cardiac index

    Time frame: Baseline, approximately 10 mins after valve repair

    Change in cardiac index 10 minutes post repair to baseline cardiac index measurement (L/min/m^2)

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Dec 16, 2019
Registry last updated
May 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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