TraNsvenous TrIcuspid Valve ReplacemenT With LuX-Valve Plus System (TRINITY-US)
NCT Number: NCT06568003
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Tricuspid Regurgitation (TR)
Interventions: DEVICE: Transcatheter Tricuspid Valve Intervention
Sponsor: Jenscare Innovation Inc.
Collaborators: Cardiovascular Research Foundation, New York
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 15
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2030-01

Summary:
The LuX-Valve Plus System is intended for the treatment of patients with at least severe TR who are symptomatic and determined by a Heart Team not to be suitable for surgical treatment. This study aims to assess the safety and effectiveness of the LuX-Valve Plus System in high-surgical risk patients with at least severe tricuspid regurgitation (TR).

Primary Outcome Measures: Primary Outcome - Post-procedural TR Remission Rate, Defined as: Post-procedural TR of moderate or less (TR≤2+) without clinically significant paravalvular leak (PVL) on a transthoracic echocardiography (TTE) at 30 days post- procedure (Assessed by the Echocardiography Core Lab using a 5-grade classification), at 30 days post procedure|Primary Outcome - Incidence of major adverse events at 30 days post procedure, A composite endpoint of Major Adverse Event (MAE) at 30 days post procedure, as listed below:

* Cardiovascular Death
* Myocardial Infarction (MI)
* Stroke
* New Onset Renal Failure Requiring Unplanned Dialysis or Hemofiltration
* Major Bleeding (includes type 3b or higher as defined by Tricuspid Valve Academic Research Consortium \[TVARC\])
* Tricuspid Valve Surgery or Transcatheter Re-intervention post Procedure
* Major Access Site and Vascular Complications
* Major Cardiac Complications
* Device-related Pulmonary Embolism
* New Pacemaker Implantation due to Atrioventricular (AV) Block, at 30 days post procedure
Secondary Outcome Measures: Acute Secondary Endpoints - Intraprocedural success Rate, Subjects in whom all of the following were present were considered intraprocedural success, otherwise they were considered intraprocedural failure:

* Absence of intraprocedural mortality or stroke; and
* Successful access, delivery, and retrieval of the device delivery system
* Successful deployment and correct positioning of the intended device without requiring implantation of unplanned additional device
* Adequate performance of the transcatheter device. Absence of tricuspid stenosis (TVA ≥1.5cm2 or TVAi≥0.9cm2/m2), DVI\<2.2, mean gradient \<5mmHg; reduction of total tricuspid regurgitation to acceptable (moderate \[2+\])
* Absence of device-related obstruction of forward flow
* Absence of device-related pulmonary embolism
* Freedom from emergency surgery or reintervention during the first 24h related to the device or access procedure, the first 24h post-procedure|Acute Secondary Endpoints - Clinical success Rate, Subjects in whom all of the following were present were considered clinical success:

* Absence of procedural mortality and stroke
* Proper position of the device with adequate performance of the transcatheter device. Absence of tricuspid stenosis (TVA≥1.5cm2 or TVAi≥0.9cm2/m2), DVI\<2.2, mean gradient\<5mmHg; reduction of total tricuspid regurgitation to moderate \[2+\]
* Freedom from unplanned surgical or interventional procedures related to the device or access procedure
* Absence of MAEs, including:

  1. Life-threatening bleeding (TVARC 5)
  2. Major vascular complications
  3. Major cardiac structural complications
  4. Stage 2 or 3 acute kidney injury (includes new dialysis)
  5. Myocardial infarction or coronary ischemia requiring percutaneous coronary intervention or coronary artery bypass graft.
  6. Device-related obstruction of forward flow
  7. Device-related pulmonary embolism
  8. Hemodynamic compromise leading to heart transplantation or major cardiac, at 30 days and at 1 year post-procedure