Multiparametric Protocol for Assessment of Intraprocedural Result of MITRACLIP Procedure

Recruiting

• Conditions: Residual Mitral Regurgitation

• Registration Number: NCT06184789
• Lead Sponsor: IRCCS San Raffaele

Brief Summary

Quantification of residual mitral regurgitation (MR) after MitraClip may be challenging. Quantitative methods for severity assessment may be inaccurate and recent recommendations suggest an assessment of changes in both hemodynamic and echocardiographic parameters, but an established prospectively validated approach is still lacking.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-27
• Primary Completion: 2020-04-30
• Status Verified: 2023-12
• Study First Submitted: 2023-12-15
• Study First Submitted QC: 2023-12-15
• Last Update Submitted: 2023-12-15
• Study First Posted: 2023-12-28
• Last Update Posted: 2023-12-28
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy of multiparametric assessment of mitral regurgitation ofter Mitraclip	one month

Trial Locations

Locations (1)

IRCSS San Raffaele; 🇮🇹 Milan, Italy