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TRISCEND II Pivotal Trial

NCT04482062 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 864

Last updated 2026-02-27

No results posted yet for this study

Summary

Pivotal trial to evaluate the safety and effectiveness of the Edwards EVOQUE tricuspid valve replacement system

Conditions

Interventions

DEVICE

Edwards EVOQUE System

Transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with OMT

DRUG

Optimal Medical Therapy

Optimal Medical Therapy

Sponsors & Collaborators

  • Edwards Lifesciences

    lead INDUSTRY

Principal Investigators

  • Rebecca Hahn, MD · Columbia University

  • Susheel Kodali, MD · Columbia University

  • Philipp Lurz, MD · Herzzentrum Leipzig GmbH

  • Vinod Thourani, MD · Piedmont Heart Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-09
Primary Completion
2025-12-05
Completion
2030-06-27
FDA Device
Yes

Countries

  • United States
  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04482062 on ClinicalTrials.gov