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

ACTIVE NOT RECRUITING

Destination Therapy Post Approval Study

NCT03681210 · View on ClinicalTrials.gov ↗

Study Summary

Medtronic is sponsoring the HeartWare™ HVAD™ Destination Therapy (DT) Post Approval Study (PAS) to further confirm safety and effectiveness of the HeartWare Ventricular Assist Device System (HVAD System) when used as intended, in "real-world" clinical practice. The Destination Therapy Post Approval Study (DT PAS) is conducted within Medtronic's Product Surveillance Platform.

Conditions Studied

Interventions

  • DEVICE HeartWare Ventricular Assist Device

Study Locations (20)

Florida

  • University of Miami — Coral Gables
  • Mayo Clinic (Jacksonville FL) — Jacksonville
  • AdventHealth — Orlando
  • University of South Florida Health — Tampa

California

  • University of California San Diego — San Diego
  • University of California San Francisco Medical Center — San Francisco
  • Stanford University Hospital — Stanford

Illinois

  • Northwestern University — Chicago
  • Loyola University — Maywood
  • Advocate Christ Medical Center (Cardiac Surgery Clinical Research Center) — Oak Lawn

Maryland

  • University of Maryland Medical Center — Baltimore
  • The Johns Hopkins Hospital — Baltimore

Massachusetts

  • Tufts Medical Center — Boston
  • Massachusetts General Hospital — Boston

Arkansas

  • Saint Vincent Heart Clinic Arkansas — Little Rock

Colorado

  • University of Colorado — Aurora

Indiana

  • Saint Vincent Medical Group — Indianapolis

Trial Details

FieldValue
Enrollment Target 300 participants
Start Date 2018-10-31
Est. Completion 2026-04

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03681210

The ClinicalTrials.gov registry entry for NCT03681210 describes a study currently listed as active not recruiting. It is categorized as an unspecified phase, 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 300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medtronic Cardiac Rhythm and Heart Failure, which has 56 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 Chronic Heart Failure appearing as the primary indexed condition, and to 1 intervention — of which HeartWare Ventricular Assist 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: NCT03681210 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Florida, California, Illinois. 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 NCT03681210 about?

NCT03681210 is a clinical study titled "Destination Therapy Post Approval Study". Medtronic is sponsoring the HeartWare™ HVAD™ Destination Therapy (DT) Post Approval Study (PAS) to further confirm safety and effectiveness of the HeartWare Ventricular Assist Device System (HVAD System) when used as intended, in "real-world" clinical practice. The Destination Therapy Post Approval...

What is the current status of trial NCT03681210?

This trial is currently active not recruiting. The enrollment target is 300 participants. The study started on 2018-10-31. Estimated completion is 2026-04.

What conditions does trial NCT03681210 study?

This clinical trial studies the following conditions: Chronic 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 NCT03681210?

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

Who is sponsoring clinical trial NCT03681210?

This trial is sponsored by Medtronic Cardiac Rhythm and Heart Failure, which has 56 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03681210 being conducted?

This trial has 20 study locations across Arkansas, California, Colorado, Florida, Illinois. 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