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NCT05836493 Clinical Trial

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
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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:

Study Design

Related Conditions & MeSH terms

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
See also
  Status Clinical Trial Phase
Recruiting NCT05434507 - Feasibility Study of Treating Tricuspid Regurgitation With K-ClipTM Transcatheter Annuloplasty System N/A
Completed NCT03144024 - Comparison of Rigid Annuloplasty Ring With a Band in the Correction of Secondary Tricuspid Insufficiency N/A
Enrolling by invitation NCT05825898 - Outcome of Patients With Severe Functional TR According to Medical, Transcatheter or Surgical Treatment
Enrolling by invitation NCT06033274 - Global Multicenter Registry on Transcatheter TRIcuspid Valve RePLACEment
Recruiting NCT05671640 - Feasibility Study of the DragonFly-T System for Severe Tricuspid Regurgitation N/A
Recruiting NCT06027307 - Enavogliflozin Outcome Trial in Functional Tricuspid Regurgitation Phase 3
Terminated NCT04665583 - Prehab Prior to Undergoing Tricuspid Intervention
Recruiting NCT06307262 - European Registry of Transcatheter Repair for Tricuspid Regurgitation
Completed NCT02981953 - TRI-REPAIR: TrIcuspid Regurgitation RePAIr With CaRdioband Transcatheter System N/A
Recruiting NCT04433065 - TTVR Early Feasibility Study N/A
Not yet recruiting NCT05556460 - Safety and Effectiveness Study of DragonFly-T System for Severe Tricuspid Regurgitation N/A
Recruiting NCT05667519 - Prevention of Pacemaker Lead Induced Tricuspid regurgitAtion by Transesophageal eCho guidEd Implantation (PLACE) N/A
Recruiting NCT04653428 - German Registry for Transcatheter Tricuspid Valve Interventions
Recruiting NCT05179616 - Pforzheim Tricuspid Valve Registry - Outcomes of Percutaneous Tricuspid Valve Repair
Completed NCT02644616 - The Safety and Efficacy of Tolvaptan for Patients With Tricuspid Regurgitation and Right Heart Failure After Left Heart Valves Replacement Phase 4
Recruiting NCT05328284 - PASCAL for Tricuspid Regurgitation - a European Registry
Not yet recruiting NCT05848284 - Clinical Safety and Efficacy of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation ( VISTA-US) Phase 1
Active, not recruiting NCT02675244 - Evaluating the Benefit of Concurrent Tricuspid Valve Repair During Mitral Surgery N/A
Recruiting NCT05436028 - A Study to Evaluate the Safety and Performance of LuX-Valve Plus System for Tricuspid Replacement N/A
Not yet recruiting NCT06137807 - TRIcvalve biCAVal Valve System for Severe Tricuspid Regurgitation (TRICAV) N/A