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

NCT04200378 | Completed

• 1 other identifier: 19-004449
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Mitral Regurgitation

Outcome Measures

Primary Outcomes (2)

• Change in stroke volume index

  Change in stroke volume index 10 minutes post repair to baseline stroke volume index measurement (L/m\^2)

  Baseline, approximately 10 mins after valve repair

• Change in cardiac index

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

  Baseline, approximately 10 mins after valve repair

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients receiving a standard of care TMVR with Transcatheter edge to edge repair device for mitral regurgitation symptom alleviation.

You may qualify if:

• 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

You may not qualify if:

• Women who are pregnant or believe they could be pregnant

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Biospecimen

Retention: SAMPLES WITH DNA

Blood Draw

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Mackram Eleid, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 13, 2019
• First Posted: December 16, 2019
• Study Start: August 20, 2020
• Primary Completion: February 13, 2023
• Study Completion: April 11, 2024
• Last Updated: May 23, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)