Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

ACTIVE NOT RECRUITING NA

TRILUMINATE Pivotal Trial

NCT03904147 · View on ClinicalTrials.gov ↗

Study Summary

The primary objective of this trial is to demonstrate the safety and effectiveness of the TriClip device in improving clinical outcomes in symptomatic patients with severe tricuspid regurgitation (TR), who are at intermediate or greater estimated risk for mortality or morbidity with tricuspid valve surgery. This randomized controlled trial will compare the investigational device (TriClip device) to Control (Medical Therapy).

Conditions Studied

Interventions

  • DEVICE TriClipTM Device

Study Locations (20)

California

  • Scripps Green Hospital — La Jolla
  • Cedars-Sinai Medical Center — Los Angeles
  • El Camino Hospital — Mountain View
  • Providence Medical Foundation (St. Joseph Hospital) — Orange
  • Sutter Medical Center, Sacramento — Sacramento
  • University of California - Davis Medical Center — Sacramento
  • California Pacific Medical Center — San Francisco
  • Los Robles Regional Medical Center — Thousand Oaks

Arizona

  • St. Joseph's Hospital & Medical Center — Phoenix
  • Arizona Cardiovascular Research Center — Phoenix
  • Phoenix Cardiovascular Research Group — Phoenix
  • Scottsdale Healthcare Shea — Scottsdale
  • Tucson Medical Center — Tucson

Florida

  • JFK Medical Center — Atlantis
  • Manatee Memorial Hospital — Bradenton
  • Morton Plant Valve Clinic — Clearwater
  • Delray Medical Center — Delray Beach

Alabama

  • University Hospital - University of Alabama at Birmingham — Birmingham

Colorado

  • University of Colorado Hospital — Aurora

Connecticut

  • Yale New Haven — New Haven

Trial Details

FieldValue
Enrollment Target 572 participants
Start Date 2019-08-21
Est. Completion 2029-04
Phase NA

Sponsor

Abbott Medical Devices

155 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03904147

The ClinicalTrials.gov registry entry for NCT03904147 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 572 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Abbott Medical Devices, which has 155 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Tricuspid Regurgitation appearing as the primary indexed condition, and to 1 intervention — of which TriClipTM Device 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: NCT03904147 reports 20 study locations spanning 6 distinct geographic areas — top geographies include California, Arizona, Florida. 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 NCT03904147 about?

NCT03904147 is a clinical study titled "TRILUMINATE Pivotal Trial". The primary objective of this trial is to demonstrate the safety and effectiveness of the TriClip device in improving clinical outcomes in symptomatic patients with severe tricuspid regurgitation (TR), who are at intermediate or greater estimated risk for mortality or morbidity with tricuspid valve ...

What is the current status of trial NCT03904147?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 572 participants. The study started on 2019-08-21. Estimated completion is 2029-04.

What conditions does trial NCT03904147 study?

This clinical trial studies the following conditions: Tricuspid Regurgitation. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03904147?

The interventions under investigation include: TriClipTM Device (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03904147?

This trial is sponsored by Abbott Medical Devices, which has 155 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03904147 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. 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