Assessing Mitral Regurgitation After MitraClip Procedure
Multiparametric Protocol for Assessment of Intraprocedural Result of MITRACLIP Procedure
IRCCS San Raffaele · NCT06184789
This study is testing a new way to measure how well the MitraClip procedure works for people with mitral regurgitation by looking at their heart function after the treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | IRCCS San Raffaele (other) |
| Locations | 1 site (Milan) |
| Trial ID | NCT06184789 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of a multiparametric protocol for assessing residual mitral regurgitation (MR) following the MitraClip procedure. It focuses on quantifying MR severity through echocardiographic assessments and hemodynamic parameters, addressing the challenges of accurate measurement in clinical practice. The study is being conducted at San Raffaele Hospital and includes patients with varying degrees of MR undergoing percutaneous edge-to-edge repair.
Who should consider this trial
Good fit: Ideal candidates are patients with severe or moderate to severe degenerative or functional mitral regurgitation undergoing the MitraClip procedure.
Not a fit: Patients who do not have mitral regurgitation or are not undergoing the MitraClip procedure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved assessment techniques for residual mitral regurgitation, enhancing patient outcomes post-MitraClip procedure.
How similar studies have performed: While there is ongoing research in this area, the specific multiparametric approach being evaluated in this study is novel and has not been extensively validated in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with either degenerative or functional, severe or moderate to severe mitral regurgitation (MR) undergoing percutaneous edge-to-edge repair at San Raffaele Hospital from April 2019. Exclusion Criteria: * None
Where this trial is running
Milan
- IRCSS San Raffaele — Milan, Italy (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Residual Mitral Regurgitation, MitraClip, Mitral Insufficiency