Multiparametric Protocol for Assessment of Intraprocedural Result of MITRACLIP Procedure

NCT ID: NCT06184789

Last Updated: 2023-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-27

Study Completion Date

2025-12-31

Brief Summary

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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

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Conditions

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Residual Mitral Regurgitation

Keywords

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MitraClip Residual Mitral Regurgitation Mitral Insufficiency

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Echocardiographic assessment

Echocardiographic and hemodynamics assessment of Mitraclip results

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS San Raffaele

OTHER

Sponsor Role lead

Responsible Party

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Agricola Eustachio

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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IRCSS San Raffaele

Milan, , Italy

Site Status RECRUITING

Countries

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Italy

Facility Contacts

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Eustachio Agricola, Professor

Role: primary

Other Identifiers

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INTRAPROCEDURAL-CLIP-2020

Identifier Type: -

Identifier Source: org_study_id