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NCT01627821 · ClinicalTrials.gov registry record · NA
Evaluation of the Jarvik 2000 Left Ventricular Assist System With Post-Auricular Connector--Destination Therapy Study
A NA study of Heart Failure, sponsored by Jarvik Heart.
- Recruiting
- Registry status
- NA
- Development phase
- 350
- Enrollment target
- 1
- Study location
NCT01627821: Recruiting NA study of Heart Failure, sponsored by Jarvik Heart.
NCT01627821 is a NA study of Heart Failure that is actively recruiting participants, run by Jarvik Heart. The registered enrollment target is 350 participants, below the 2,048-participant average among 397 other Heart Failure trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01627821, a NA study of Heart Failure, is actively recruiting participants, sponsored by Jarvik Heart.
- RECRUITING
- Registry status
- NA
- Development phase
- 350 participants
- Enrollment target
- 1
- Study location
Study Summary
This investigation will be conducted as an interventional intention-to-treat clinical study in a population of end stage heart failure patients who meet specific inclusion and exclusion criteria. The multi-center study will be prospective, dual-armed, non-blinded (open-label) and randomized, comparing a treatment group receiving the Jarvik 2000 LVAS with Post-Auricular Connector to an active control group treated with the PMA approved Thoratec HeartMate® II LVAS for Destination Therapy.
Conditions Studied
Interventions
- DEVICE Jarvik 2000 VAS
- DEVICE HeartMate II
Study Locations (1)
New York
- Columbia/NY Presbyterian - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 350 participants |
| Start Date | 2013-02 |
| Est. Completion | 2025-03 |
| Phase | NA |
What NCT01627821 shows while recruiting
NCT01627821 is an interventional study that assigns participants to a tested intervention. The registered 350 participants enrollment target is mid-sized for trials with a published cap, below the 2,048-participant average among 397 other Heart Failure trials with a reported enrollment target (83% lower).
The record links to 1 condition, with Heart Failure appearing as the primary indexed condition, and to 2 interventions - of which Jarvik 2000 VAS is the first listed.
NCT01627821 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT01627821 about?
NCT01627821 is a clinical study titled "Evaluation of the Jarvik 2000 Left Ventricular Assist System With Post-Auricular Connector--Destination Therapy Study". This investigation will be conducted as an interventional intention-to-treat clinical study in a population of end stage heart failure patients who meet specific inclusion and exclusion criteria. The multi-center study will be prospective, dual-armed, non-blinded (open-label) and randomized, compari...
What is the current status of trial NCT01627821?
This trial is currently recruiting. It is a NA study. The enrollment target is 350 participants. The study started on 2013-02. Estimated completion is 2025-03.
What conditions does trial NCT01627821 study?
This clinical trial studies the following conditions: Heart Failure.
What interventions are being tested in trial NCT01627821?
The interventions under investigation include: Jarvik 2000 VAS (DEVICE), HeartMate II (DEVICE).
Who is sponsoring clinical trial NCT01627821?
This trial is sponsored by Jarvik Heart, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01627821 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01627821's enrollment target sits among peer trials
350 128th of 397 higher than 269 of 397 other Heart Failure trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Heart Failure trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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