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NCT03681210 · ClinicalTrials.gov registry record

Destination Therapy Post Approval Study

A clinical trial of Chronic Heart Failure, sponsored by Medtronic Cardiac Rhythm and Heart Failure.

Active
Registry status
300
Enrollment target
20
Study locations

NCT03681210 is a study of Chronic Heart Failure that is active but no longer recruiting, run by Medtronic Cardiac Rhythm and Heart Failure. The registered enrollment target is 300 participants, below the 397-participant average among 12 other Chronic Heart Failure trials with a reported enrollment target (24% lower). The trial reports 20 study locations across 11 states.

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The verdict

NCT03681210, a study of Chronic Heart Failure, is active but no longer recruiting, sponsored by Medtronic Cardiac Rhythm and Heart Failure.

ACTIVE NOT RECRUITING
Registry status
300 participants
Enrollment target
20
Study locations

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

What the Registry Record Tells You About NCT03681210

The ClinicalTrials.gov registry entry for NCT03681210 describes a study currently listed as active not recruiting, categorized as an unspecified phase. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 397-participant average among 12 other Chronic Heart Failure trials with a reported enrollment target (24% lower). The listed sponsor is Medtronic Cardiac Rhythm and Heart Failure, which has 115 total studies on file at ClinicalTrials.gov.

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.

NCT03681210 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Florida, California, Illinois.

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.

What interventions are being tested in trial NCT03681210?

The interventions under investigation include: HeartWare Ventricular Assist Device (DEVICE).

Who is sponsoring clinical trial NCT03681210?

This trial is sponsored by Medtronic Cardiac Rhythm and Heart Failure, which has 115 total clinical trials registered on ClinicalTrials.gov.

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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.