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OpenTrials
Completed

NCT Number: NCT05836493

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

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).

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Key information

Conditions

Tricuspid Regurgitation Cardiovascular Diseases Heart Diseases Heart Valve Diseases Tricuspid Valve Insufficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

Treatment and study plan

Ring annuloplasty

Procedure

A prosthetic ring is implanted to treat tricuspid regurgitation

Suture procedure

Procedure

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

Primary outcomes

  1. Mortality

    Time frame: through study completion, a minimum of 15 years

Secondary outcomes

  1. Reintervention

    Time frame: through study completion, a minimum of 15 years

  2. TR recurrence

    Time frame: through study completion, a minimum of 15 years

Sponsors and collaborators

Lead sponsor

Michele De Bonis

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 1, 2023
Registry last updated
May 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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