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NCT04200378 Clinical Trial

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

Mitral Regurgitation Clinical Trial

Official title:
Invasive Hemodynamic Response to Transcatheter Edge-to-Edge Mitral Valve Repair

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04200378
Other study ID # 19-004449
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 20, 2020
Est. completion date April 11, 2024

Study information
Verified date May 2024
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 22
Est. completion date April 11, 2024
Est. primary completion date February 13, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
See also
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Not yet recruiting NCT06465745 - AltaValve Pivotal Trial N/A
Not yet recruiting NCT06167213 - ALLIANCE Mitral: Safety and Effectiveness of SAPIEN X4 Transcatheter Heart Valve - Mitral N/A
Withdrawn NCT05040451 - Carillon Mitral Contour System for Treatment of Exercise Induced Functional Mitral Regurgitation
Withdrawn NCT03714412 - Feasibility Study of Patients With Severe MR Treated With the Cardiovalve TMVR System N/A
Recruiting NCT02592889 - (MitraClip in Non-Responders to Cardiac Resynchronization Therapy) Phase 4
Completed NCT02355418 - The Role of Myocardial Fibrosis in Degenerative Mitral Regurgitation
Completed NCT01841554 - Cardioband With Transfemoral Delivery System N/A
Not yet recruiting NCT01431222 - Abrogation of Mitral Regurgitation Using the MitraClip System in High-Risk Patients Unsuitable for Surgery Phase 4
Not yet recruiting NCT03870516 - Left Chamber Function in Mitral Regurgitation and Predicting Outcome After Replacement and Targeting for Early Surgery N/A
Active, not recruiting NCT03230747 - SAPIEN M3 EFS: Early Feasibility Study of the Edwards SAPIEN M3 System for the Treatment of Mitral Regurgitation N/A
Enrolling by invitation NCT04031274 - Transcatheter Treatment for Combined Aortic and Mitral Valve Disease. The Aortic+Mitral TRAnsCatheter (AMTRAC) Valve Registry
Completed NCT05850026 - Mitral Regurgitation in Hypertrophic Obstructive Cardiomyopathy: Fix it in a Simple, Effective and Durable Way!
Completed NCT05836532 - Long Term Results of Surgical and Percutaneous Double Orefices Mitral Repair in Patient With p2 Prolapse Causing Degenerative Mitral Regurgitation
Completed NCT05836480 - Immediate Suboptimal Result of Mitral Valve Repair: Late Implications in a Matched Cohort Study
Recruiting NCT03975998 - Dutch-AMR: Early Mitral Valve Repair Versus Watchful Waiting in Asymptomatic Patients With Severe Mitral Regurgitation
Completed NCT01162083 - Identifying an Ideal Cardiopulmonary Exercise Test Parameter N/A
Suspended NCT00787293 - Study of Safety and Efficacy of the Percutaneous Reduction of Mitral Valve Regurgitation in Heart Failure Patients Phase 2

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