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

NCT ID: NCT04200378

Last Updated: 2024-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-20

Study Completion Date

2024-04-11

Brief Summary

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

Detailed Description

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Conditions

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Mitral Regurgitation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Subjects undergoing TMVr

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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Mackram F. Eleid

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mackram Eleid, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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19-004449

Identifier Type: -

Identifier Source: org_study_id

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