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ACTIVE NOT RECRUITING NA

TRISCEND II Pivotal Trial

NCT04482062 · View on ClinicalTrials.gov ↗

Study Summary

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

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

FieldValue
Enrollment Target 864 participants
Start Date 2021-04-09
Est. Completion 2030-06-27
Phase NA

Sponsor

Edwards Lifesciences

34 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04482062

The ClinicalTrials.gov registry entry for NCT04482062 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 864 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Edwards Lifesciences, which has 34 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04482062 reports 20 study locations spanning 10 distinct geographic areas — top geographies include California, Florida, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04482062?

The interventions under investigation include: Optimal Medical Therapy (DRUG), Edwards EVOQUE System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04482062?

This trial is sponsored by Edwards Lifesciences, which has 34 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial