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COMPLETED NA

Treatment of Tricuspid Valve Regurgitation in Patients Undergoing Left Ventricular Assist Device Implantation Study

NCT03775759 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study is to determine the utility of tricuspid valve repair at the time of LVAD implantation for patients presenting with moderate or severe tricuspid regurgitation. The study will be a randomized trial for patients presenting for LVAD implantation to either tricuspid valve repair or no tricuspid valve repair. The data will be analyzed as both an intention to treat analysis as well as an "as treated" analysis with the primary outcome being rates of right ventricular dysfunction post LVAD implantation. Tricuspid valve repair for these patient is currently being done for some patients, without any strong data to either support such practice or negate it.

Interventions

  • PROCEDURE Tricuspid valve repair or replacement
  • OTHER Medical management of tricuspid regurgitation

Study Locations (1)

North Carolina

  • Duke University Medical Center — Durham

Trial Details

FieldValue
Enrollment Target 71 participants
Start Date 2018-08-22
Est. Completion 2023-02-15
Phase NA

Sponsor

Duke University

1,129 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03775759

The ClinicalTrials.gov registry entry for NCT03775759 describes a study currently listed as completed. 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 71 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,129 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Heart Failure appearing as the primary indexed condition, and to 2 interventions — of which Tricuspid valve repair or replacement 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: NCT03775759 reports 1 study location spanning 1 distinct geographic area — top geographies include North Carolina. 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 NCT03775759 about?

NCT03775759 is a clinical study titled "Treatment of Tricuspid Valve Regurgitation in Patients Undergoing Left Ventricular Assist Device Implantation Study". The purpose of this study is to determine the utility of tricuspid valve repair at the time of LVAD implantation for patients presenting with moderate or severe tricuspid regurgitation. The study will be a randomized trial for patients presenting for LVAD implantation to either tricuspid valve repai...

What is the current status of trial NCT03775759?

This trial is currently completed. It is a NA study. The enrollment target is 71 participants. The study started on 2018-08-22. Estimated completion is 2023-02-15.

What conditions does trial NCT03775759 study?

This clinical trial studies the following conditions: Heart Failure, Tricuspid Valve Insufficiency, Right Heart Failure. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03775759?

The interventions under investigation include: Tricuspid valve repair or replacement (PROCEDURE), Medical management of tricuspid regurgitation (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03775759?

This trial is sponsored by Duke University, which has 1,129 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03775759 being conducted?

This trial has 1 study location across North Carolina. 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