Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04482062 · ClinicalTrials.gov registry record · NA
TRISCEND II Pivotal Trial
A NA study of Heart Failure and Cardiovascular Diseases, sponsored by Edwards Lifesciences.
- Active
- Registry status
- NA
- Development phase
- 864
- Enrollment target
- 20
- Study locations
NCT04482062: Active NA study of Heart Failure and Cardiovascular Diseases, sponsored by Edwards Lifesciences.
NCT04482062 is a NA study of Heart Failure and Cardiovascular Diseases that is active but no longer recruiting, run by Edwards Lifesciences. The registered enrollment target is 864 participants, below the 2,047-participant average among 397 other Heart Failure trials with a reported enrollment target (58% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04482062, a NA study of Heart Failure and Cardiovascular Diseases, is active but no longer recruiting, sponsored by Edwards Lifesciences.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 864 participants
- Enrollment target
- 20
- Study locations
Study Summary
Pivotal trial to evaluate the safety and effectiveness of the Edwards EVOQUE tricuspid valve replacement system
Primary Outcome
Comparison of number of participants with reduction in TR between experimental and active comparator arms. TR severity will be assessed using the 5-grade scale with the addition of "none/trace" to represent the lack of TR (scale: none/trace, mild, moderate, severe, massive, torrential). Lower grades of TR are better.
Conditions Studied
Interventions
- DRUG Optimal Medical Therapy
- DEVICE Edwards EVOQUE System
Study Locations (20)
California
- Scripps Memorial Hospital La Jolla - La Jolla
- Cedars-Sinai Medical Center - Los Angeles
- UC Davis Medical Center - Sacramento
- Kaiser Permanente San Francisco - San Francisco
- University of California San Francisco - San Francisco
- Stanford University - Stanford
Florida
- Florida Heart & Vascular Care - JFK - Atlantis
- The Cardiac & Vascular Institute Research Foundation - Gainesville
- NCH Heart Institute - Naples
Arizona
- SJHMC Heart and Vascular Institute - Phoenix
- Tucson Medical Center - Tucson
Georgia
- Emory University - Atlanta
- Piedmont Heart Institute - Atlanta
Kansas
- Kansas University Medical Center - Kansas City
- Ascension Via Christi St. Francis - Wichita
Colorado
- Medical Center of the Rockies - Loveland
Illinois
- Northwestern University - Chicago
Indiana
- St. Vincent Heart Center of Indiana - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 864 participants |
| Start Date | 2021-04-09 |
| Est. Completion | 2030-06-27 |
| Phase | NA |
What the registry record for NCT04482062 still lists
NCT04482062 is an interventional study that assigns participants to a tested intervention. The registered 864 participants enrollment target is mid-sized for trials with a published cap, below the 2,047-participant average among 397 other Heart Failure trials with a reported enrollment target (58% lower).
The record links to 6 conditions, with Heart Failure appearing as the primary indexed condition, and to 2 interventions - of which Optimal Medical Therapy is the first listed.
NCT04482062 names 20 study sites across 10 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT04482062 about?
NCT04482062 is a clinical study titled "TRISCEND II Pivotal Trial". Pivotal trial to evaluate the safety and effectiveness of the Edwards EVOQUE tricuspid valve replacement system
What is the current status of trial NCT04482062?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 864 participants. The study started on 2021-04-09. Estimated completion is 2030-06-27.
What conditions does trial NCT04482062 study?
This clinical trial studies the following conditions: Heart Failure, Cardiovascular Diseases, Heart Valve Diseases, Tricuspid Valve Disease, Tricuspid Valve Insufficiency.
What interventions are being tested in trial NCT04482062?
The interventions under investigation include: Optimal Medical Therapy (DRUG), Edwards EVOQUE System (DEVICE).
Who is sponsoring clinical trial NCT04482062?
This trial is sponsored by Edwards Lifesciences, which has 57 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04482062 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Heart Failure
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04482062's enrollment target sits among peer trials
864 74th of 397 higher than 324 of 397 other Heart Failure trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Heart Failure trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Early Feasibility Study of the NORM™ System in Heart Failure Patients (FUTURE-HFII)
RECRUITING · NA
-
Diuretics Alone vs. Aortix Endovascular Device for Acute Heart Failure
RECRUITING · NA
-
iCardia4HF: Multi-component mHealth Intervention for Patients With Heart Failure
RECRUITING · NA
-
Optimizing Heart Failure Therapies Among Patients With Limited Access in Denver
RECRUITING · NA
-
Hemodynamic Monitoring to Prevent Adverse Events foLlowing cardiOgenic Shock Trial
RECRUITING · NA
-
Effect of a Quality Improvement Initiative to Address Social Determinants of Health on Rehospitalization Rates in Patients With Heart Failure
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06256588 · 864 participants · Phase 3
A Study of Dostarlimab vs Placebo After Chemoradiation in Adult Participants With Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma
- NCT06527794 · 864 participants · NA
Remote Hypertension Management for Black Patients
- NCT05369052 · 865 participants · Phase 3
Safety and Efficacy Study of Contezolid Acefosamil and Contezolid Compared to Linezolid Administered Intravenously and Orally to Adults With Moderate or Severe Diabetic Foot Infections (DFI)
- NCT05914116 · 862 participants · Phase 1
A Phase 1/2a Study of DB-1311/BNT324 in Advanced/Metastatic Solid Tumors
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI