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

Tricuspid Regurgitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05836493
• Other study ID #: VLT-TVR
• Status: Completed
• Start date: October 7, 2020
• Est. completion date: October 23, 2020

Study information

• Verified date: April 2023
• Source: Ospedale San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: October 23, 2020
• Est. primary completion date: October 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Tricuspid Regurgitation
• Tricuspid Valve Insufficiency

Intervention

Procedure:
• Ring annuloplasty
A prosthetic ring is implanted to treat tricuspid regurgitation
• Suture procedure
Suture techniques such as Kay or De Vega are used to reduce tricuspid annulus in order to treat tricuspid regurgitation

Locations

Country	Name	City	State
Italy	IRCCS Ospedale San Raffaele	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Michele De Bonis

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality		through study completion, a minimum of 15 years
Secondary	Reintervention		through study completion, a minimum of 15 years
Secondary	TR recurrence		through study completion, a minimum of 15 years