NCT06184789

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 27, 2020

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

December 15, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 28, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

December 28, 2023

Status Verified

December 1, 2023

Enrollment Period

3 days

First QC Date

December 15, 2023

Last Update Submit

December 15, 2023

Conditions

Residual Mitral Regurgitation

Keywords

MitraClipResidual Mitral RegurgitationMitral Insufficiency

Outcome Measures

Primary Outcomes (1)

  • Efficacy of multiparametric assessment of mitral regurgitation ofter Mitraclip

    one month

Interventions

Echocardiographic assessmentDIAGNOSTIC_TEST

Echocardiographic and hemodynamics assessment of Mitraclip results

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • 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.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCSS San Raffaele

Milan, Italy

RECRUITING

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 15, 2023

First Posted

December 28, 2023

Study Start

April 27, 2020

Primary Completion

April 30, 2020

Study Completion

December 31, 2025

Last Updated

December 28, 2023

Record last verified: 2023-12

Locations

IT(1)