TRILUMINATE Pivotal Trial

Status Active, not recruiting

Clinical Trial Summary

The primary objective of this trial is to demonstrate the safety and effectiveness of the TriClip device in improving clinical outcomes in symptomatic patients with severe tricuspid regurgitation (TR), who are at intermediate or greater estimated risk for mortality or morbidity with tricuspid valve surgery. This randomized controlled trial will compare the investigational device (TriClip device) to Control (Medical Therapy).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03904147
Study type	Interventional
Source	Abbott Medical Devices
Contact
Status	Active, not recruiting
Phase	N/A
Start date	August 21, 2019
Completion date	April 2029

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See also
Status	Clinical Trial	Phase
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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
Completed	`NCT05836493` - Very Long-term (>15 Years) Results of Tricuspid Valve Repair.
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
Completed	`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
Completed	`NCT01093001` - Tricuspid Regurgitation Study	Phase 4