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Clinical Trials/NCT05836493
NCT05836493
Completed
Not Applicable

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

Michele De Bonis1 site in 1 country146 target enrollmentOctober 7, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Tricuspid Regurgitation
Sponsor
Michele De Bonis
Enrollment
146
Locations
1
Primary Endpoint
Mortality
Status
Completed
Last Updated
3 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
October 7, 2020
End Date
October 23, 2020
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor Investigator
Principal Investigator

Michele De Bonis

Chief of Cardiac Surgery of Advanced and Research Therapies

Ospedale San Raffaele

Eligibility Criteria

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

  • Not provided

Outcomes

Primary Outcomes

Mortality

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

Secondary Outcomes

  • TR recurrence(through study completion, a minimum of 15 years)
  • Reintervention(through study completion, a minimum of 15 years)

Study Sites (1)

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