Very Long-term (>15 Years) Results of Tricuspid Valve Repair.

NCT ID: NCT05836493

Last Updated: 2023-05-01

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

COMPLETED

Total Enrollment

146 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-07

Study Completion Date

2020-10-23

Brief Summary

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Interest in Tricuspid valve disease grew exponentially in the last years in response to an increased awareness of the poor outcome of patients with functional Tricuspid Regurgitation (TR). Earlier reports advocated for a more conservative TR management in patients undergoing left-sided heart valve surgery but more recent guidelines advised for a more aggressive TR management, as accumulating evidence demonstrates its adverse impact on long term morbidity and mortality. Several papers have been published analyzing the results of surgical tricuspid valve repair but the length of the follow-up is usually limited to 10 to 12 years. With this study the investigators aim to analyze the very long-term results (\>15years) of tricuspid valve repair according to the surgical method employed for valve repair (suture vs ring annuloplasty).

Detailed Description

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Conditions

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Tricuspid Regurgitation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Ring annuloplasty

Ring annuloplasty

Intervention Type PROCEDURE

A prosthetic ring is implanted to treat tricuspid regurgitation

Suture procedure

Suture procedure

Intervention Type PROCEDURE

Suture techniques such as Kay or De Vega are used to reduce tricuspid annulus in order to treat tricuspid regurgitation

Interventions

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Ring annuloplasty

A prosthetic ring is implanted to treat tricuspid regurgitation

Intervention Type PROCEDURE

Suture procedure

Suture techniques such as Kay or De Vega are used to reduce tricuspid annulus in order to treat tricuspid regurgitation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* cardiac surgery treatment of TR, isolated or in conjunction with other procedures on the left heart
* patients operated on between January 1998 and December 2004
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Michele De Bonis

OTHER

Sponsor Role lead

Responsible Party

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Michele De Bonis

Chief of Cardiac Surgery of Advanced and Research Therapies

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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IRCCS Ospedale San Raffaele

Milan, , Italy

Site Status

Countries

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Italy

Other Identifiers

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VLT-TVR

Identifier Type: -

Identifier Source: org_study_id

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