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NCT07131631 · ClinicalTrials.gov registry record
Secondary Mitral Regurgitation Treatment With MitraClip and Assessment by Cardiac Magnetic Resonance
A clinical trial of Functional Mitral Regurgitation and Heart Failure and Reduced Ejection Fraction, sponsored by Minneapolis Heart Institute Foundation.
- Recruiting
- Registry status
- 125
- Enrollment target
- 6
- Study locations
NCT07131631: Recruiting study of Functional Mitral Regurgitation and Heart Failure and Reduced Ejection Fraction, sponsored by Minneapolis Heart Institute Foundation.
NCT07131631 is a study of Functional Mitral Regurgitation and Heart Failure and Reduced Ejection Fraction that is actively recruiting participants, run by Minneapolis Heart Institute Foundation. The registered enrollment target is 125 participants, below the 406-participant average among 5 other Functional Mitral Regurgitation trials with a reported enrollment target (69% lower). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07131631, a study of Functional Mitral Regurgitation and Heart Failure and Reduced Ejection Fraction, is actively recruiting participants, sponsored by Minneapolis Heart Institute Foundation.
- RECRUITING
- Registry status
- 125 participants
- Enrollment target
- 6
- Study locations
Study Summary
This is a multi-center, prospective, observational study designed to evaluate the impact of LV myocardial fibrosis extent assessed by CMR on LV reverse remodeling and clinical outcomes post TEER. The target sample will be up to 125 patients enrolled to achieve 100 evaluable at 6 months of follow-up. Enrollment will occur at up to eight centers.
Primary Outcome
change in LV end-diastolic volume index \[LVEDVi\] 6 months after TEER
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Cardiac MRI
Study Locations (6)
Ohio
- The Christ Hospital Health Network - Cincinnati
- Cleveland Clinic - Cleveland
Minnesota
- Minneapolis Heart Institute Foundation - Minneapolis
North Carolina
- Sanger Heart and Vascular Institute - Charlotte
Virginia
- Inova Fairfax Medical Campus - Falls Church
Other
- IRCCS Ospedale San Raffaele - Milan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 125 participants |
| Start Date | 2022-03-03 |
| Est. Completion | 2027-07 |
What NCT07131631 shows while recruiting
NCT07131631 is an observational study that tracks outcomes without assigning an intervention. The registered 125 participants enrollment target is mid-sized for trials with a published cap, below the 406-participant average among 5 other Functional Mitral Regurgitation trials with a reported enrollment target (69% lower).
The record links to 2 conditions, with Functional Mitral Regurgitation appearing as the primary indexed condition, and to 1 intervention - of which Cardiac MRI is the first listed.
NCT07131631 lists 6 locations in 5 states (Ohio, Minnesota, North Carolina).
Frequently Asked Questions
What is clinical trial NCT07131631 about?
NCT07131631 is a clinical study titled "Secondary Mitral Regurgitation Treatment With MitraClip and Assessment by Cardiac Magnetic Resonance". This is a multi-center, prospective, observational study designed to evaluate the impact of LV myocardial fibrosis extent assessed by CMR on LV reverse remodeling and clinical outcomes post TEER. The target sample will be up to 125 patients enrolled to achieve 100 evaluable at 6 months of follow-up....
What is the current status of trial NCT07131631?
This trial is currently recruiting. The enrollment target is 125 participants. The study started on 2022-03-03. Estimated completion is 2027-07.
What conditions does trial NCT07131631 study?
This clinical trial studies the following conditions: Functional Mitral Regurgitation, Heart Failure and Reduced Ejection Fraction.
What interventions are being tested in trial NCT07131631?
The interventions under investigation include: Cardiac MRI (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT07131631?
This trial is sponsored by Minneapolis Heart Institute Foundation, which has 22 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07131631 being conducted?
This trial has 6 study locations across Minnesota, North Carolina, Ohio, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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