2019-06 TRISCEND Study

Condition(s) studied

Investigational drug(s) / intervention(s)

Transcatheter Tricuspid Valve Replacement: Replacement of the tricuspid valve through a transcatheter approach

Study summary

Prospective, multi-center study to assess safety and performance of the Edwards EVOQUE Tricuspid Valve Replacement System

Eligibility

Primary outcome measure(s)

• Composite Major Adverse Events (MAEs) — 30 Days
  Composite of major adverse events (MAE) defined as cardiovascular mortality, myocardial infarction, stroke, renal complications requiring unplanned dialysis or renal replacement therapy, severe bleeding, unplanned or emergency tricuspid valve re-intervention, major access site and vascular complications, major access site and vascular complications, and device-related pulmonary embolism at 30 days.
• Device Success — Intraprocedural
  Study device is deployed as intended and the delivery system is successfully retrieved as intended at the time of the patient's exit from the cardiac catheterization laboratory.
• Procedure Success — Discharge (Up to 7 days post procedure)
  Device success without clinically significant paravalvular leak (PVL) on a transthoracic echocardiogram (assessed by the echo core lab) at time of discharge.
• Clinical Success — 30 Days
  Procedural success without MAEs at 30 days.
• Tricuspid Regurgitation Reduction — Discharge (Up to 7 days post procedure)
  Percentage of patients with at least 1 grade reduction in tricuspid regurgitation (TR) as measured by using a 5-grade classification system (mild, moderate, severe, massive, torrential). TR grade is assessed by an independent echocardiography core laboratory.

Trial sites (20)

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