Change in LVEF Following Transcatheter Mitral Edge-To-Edge Repair
MITRA-EF
MITRA-EF: A Multi-Center Registry Evaluating Left Ventricular Function in Patients Undergoing Transcatheter Mitral Edge-To-Edge Repair
1 other identifier
observational
4,000
1 country
1
Brief Summary
Little is known regarding the impact of transcatheter mitral valve edge-to-edge repair (TEER) on the acute changes in left ventricular ejection fraction (LVEF) and the effect of an acute reduction in LVEF, the so-called "afterload mismatch" (AM), on prognosis. We thereby aim to assess changes in LVEF after TEER, identify rate and predictors AM, and estimate its impact on prognosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2021
CompletedFirst Submitted
Initial submission to the registry
March 28, 2022
CompletedFirst Posted
Study publicly available on registry
April 5, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2022
CompletedApril 5, 2022
March 1, 2022
1 year
March 28, 2022
March 28, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Mortality
Rates of all cause death
12 months
MACE
Rates of major adverse cardiac events (MACE= a composite of death, need for mitral surgery or percutaneous repair and rates of grade 3+ or 4+ mitral regurgitation)
12 months
Secondary Outcomes (4)
LV Function and size
12 months
NYHA
12 months
Heart failure admissions
12 months
Need for mitral surgery or percutaneous repair
2 months
Interventions
Transcatheter Mitral Edge-To-Edge Repair
Eligibility Criteria
All patients undergoing TEER using the MitraClip percutaneous mitral valve repair (Abbott Vascular, Inc., Santa Clara, California) are included.
You may not qualify if:
- patients who are taken immediately to surgery following the procedure
- those who did not have echocardiographic information in the first 30 days post TEER
- patients who have undergone combined mitral and tricuspid repair
- severe non-cardiovascular diseases such as systemic infection or malignancy
- cardiogenic shock presenting at baseline
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rabin Medical Center
Petah Tikva, Central District, 49100, Israel
Related Publications (1)
Perl L, Kheifets M, Guido A, Agricola E, Denti P, Wild MG, Praz F, Rubbio AP, Bedogni F, De Marco F, Beeri R, Shuvy M, Melillo F, Montorfano M, Freixa X, de la Fuente Mancera JC, Giordano A, Finizio F, Van Mieghem NM, Ooms JFW, Fam N, O'Connor C, Toggweiler S, Levi A, Shapira Y, Schwartzenberg S, Pidello S, D'Ascenzo F, Angelini F, Haberman D, Crimi G, Porto I, Cozzi O, Giannini F, Tarantini G, Maisano F, Kornowski R; MITRA-EF study *. Acute Reduction in Left Ventricular Function Following Transcatheter Mitral Edge-to-Edge Repair. J Am Heart Assoc. 2023 Jul 4;12(13):e029735. doi: 10.1161/JAHA.123.029735. Epub 2023 Jun 22.
PMID: 37345813DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Target Duration
- 1 Year
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 28, 2022
First Posted
April 5, 2022
Study Start
August 1, 2021
Primary Completion
August 1, 2022
Study Completion
August 1, 2022
Last Updated
April 5, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share