Very Long-term (>15 Years) Results of Tricuspid Valve Repair.
1 other identifier
observational
146
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 7, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 23, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 23, 2020
CompletedFirst Submitted
Initial submission to the registry
January 27, 2023
CompletedFirst Posted
Study publicly available on registry
May 1, 2023
CompletedMay 1, 2023
April 1, 2023
16 days
January 27, 2023
April 28, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Mortality
through study completion, a minimum of 15 years
Secondary Outcomes (2)
Reintervention
through study completion, a minimum of 15 years
TR recurrence
through study completion, a minimum of 15 years
Study Arms (2)
Ring annuloplasty
Suture procedure
Interventions
A prosthetic ring is implanted to treat tricuspid regurgitation
Suture techniques such as Kay or De Vega are used to reduce tricuspid annulus in order to treat tricuspid regurgitation
Eligibility Criteria
\- patients operated for non-valvular procedures (e.g. coronary artery bypass)
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Michele De Bonislead
Study Sites (1)
IRCCS Ospedale San Raffaele
Milan, 20132, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Chief of Cardiac Surgery of Advanced and Research Therapies
Study Record Dates
First Submitted
January 27, 2023
First Posted
May 1, 2023
Study Start
October 7, 2020
Primary Completion
October 23, 2020
Study Completion
October 23, 2020
Last Updated
May 1, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share