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NCT02268942 · ClinicalTrials.gov registry record · NA

HW006 LATERAL Thoracotomy

A NA study, sponsored by Medtronic Cardiac Rhythm and Heart Failure.

Completed
Registry status
NA
Development phase
144
Enrollment target

NCT02268942: Completed NA study, sponsored by Medtronic Cardiac Rhythm and Heart Failure.

NCT02268942 is a NA study that has completed, run by Medtronic Cardiac Rhythm and Heart Failure. The registered enrollment target is 144 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02268942, a NA study, has completed, sponsored by Medtronic Cardiac Rhythm and Heart Failure.

COMPLETED
Registry status
NA
Development phase
144 participants
Enrollment target

Study Summary

This is a prospective, multi-center,single-arm study that will evaluate the thoracotomy implant technique in up to 145 subjects implanted via thoracotomy with the HeartWare HVAD System and enrolled in the Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs®) protocol and database. All participating centers are current INTERMACS® sites in good standing and follow the INTERMACS® protocol and procedures.

Primary Outcome

* Alive on the originally implanted device at six months, and the subject has not had a stroke with a modified Rankin Scale ≥ 4 (assessed ≥ three months post-stroke event); or * Transplanted by Month 6, and the subject has not had a stroke with a modified Rankin Scale ≥ 4 (assessed ≥ three months post-stroke event); or * Explanted for recovery by Month 6, and the subject has not had a stroke with a modified Rankin Scale ≥ 4 (assessed ≥ three months post-stroke event).

Interventions

  • PROCEDURE Thoracotomy
  • DEVICE HeartWare HVAD

Trial Details

FieldValue
Enrollment Target 144 participants
Start Date 2014-11
Est. Completion 2018-10
Phase NA

What the finished NCT02268942 record still lists

NCT02268942 is an interventional study that assigns participants to a tested intervention. The registered 144 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower).

The record links to 0 conditions, and to 2 interventions - of which Thoracotomy is the first listed.

NCT02268942 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02268942 about?

NCT02268942 is a clinical study titled "HW006 LATERAL Thoracotomy". This is a prospective, multi-center,single-arm study that will evaluate the thoracotomy implant technique in up to 145 subjects implanted via thoracotomy with the HeartWare HVAD System and enrolled in the Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs®) protocol and da...

What is the current status of trial NCT02268942?

This trial is currently completed. It is a NA study. The enrollment target is 144 participants. The study started on 2014-11. Estimated completion is 2018-10.

What interventions are being tested in trial NCT02268942?

The interventions under investigation include: Thoracotomy (PROCEDURE), HeartWare HVAD (DEVICE).

Who is sponsoring clinical trial NCT02268942?

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

How this trial's enrollment target compares

Where NCT02268942's enrollment target sits among peer trials

144 706th of 2000 higher than 1,290 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA 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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Source: ClinicalTrials.gov NCT02268942, the US trial registry maintained by the National Library of Medicine. NCT02268942 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.