Left Sided Heart FailureHVADNCT02268942
HW006 LATERAL Thoracotomy
A study testing HeartWare HVAD and Thoracotomy in people with Left Sided Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 26 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Left Sided Heart Failure
- What is being tested?
- HeartWare HVAD and Thoracotomy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 26 sitesin 2 countries
- Study dates
- Nov 2014to Oct 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be ≥19 years of age at time of informed consent to participate in the Intermacs® registry.
- Subject receives a HeartWare HVAD (The device should be the subject's first VAD implant).
- Subject signed an Intermacs® informed consent if required by local IRB policy.
- Subject signed a HeartWare informed consent.
Who cannot join
- Subject is incarcerated (prisoner).
- Subject did not sign the informed consent at sites where waiver of consent was not granted.
- Body Surface Area (BSA) < 1.2 m^2.
- Prior cardiac transplant or cardiomyoplasty.
- Subject is receiving a BiVAD.
- Subject is receiving the device as an RVAD.
Show all 14Show fewer
- Subject data is generated from non- Intermacs® centers.
- Pediatric subjects (< 19 years of age).
- Subjects who receive a temporary LVAD
- Subjects whose device strategy is listed as "Destination Therapy" at the time of implant.
- Severe Right Heart failure
- Aortic insufficiency or mechanical aortic valve.
- Planned concomitant procedure (e.g.valve repair or replacement, CABG, septal defect repair).
- Known LV Thrombus.
Trial locations and contacts
26 sites in 2 countries.
26 sites in 2 countries
United States25 sites
University of Michigan Hospital
Ann Arbor, Michigan, 48109
The University of Alabama
Birmingham, Alabama, 35294
Tufts Medical Center
Boston, Massachusetts, 02111
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Duke University Medical Center
Durham, North Carolina, 27710
Inova Fairfax Hospital
Falls Church, Virginia, 22042
Spectrum Health
Grand Rapids, Michigan, 49503
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
IU Health Methodist
Indianapolis, Indiana, 46202
St. Vincent Hospital
Indianapolis, Indiana, 46262
St. Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
Jewish Hospital - Rudd Heart and Lung Institute
Louisville, Kentucky, 40202
Loyola University Medical Center
Maywood, Illinois, 60153
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-8802
John Ochsner Heart & Vascular Institute
New Orleans, Louisiana, 70115
Stanford University School of Medicine
Palo Alto, California, 94305
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Virginia Commonwealth University
Richmond, Virginia, 23298-0068
Mayo Rochester - St. Mary's Hospital
Rochester, Minnesota, 55905
UC San Diego
San Diego, California, 92093
UCSF Medical Center
San Francisco, California, 94143
University of Washington Medical Center
Seattle, Washington, 98195-6310
Tampa Transplant Institute/Tampa General Hospital
Tampa, Florida, 33606
Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: A Prospective, Single-Arm, Multi-Center Study in Collaboration With INTERMACS to Evaluate the Thoracotomy Implant Technique of the HeartWare™ HVAD™ System in Patients With Advanced Heart Failure
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.
- Conditions
- Left Sided Heart Failure
- Being tested
- HeartWare HVAD, Thoracotomy
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeartWare HVADDevice
Implant of HeartWare HVAD via thoracotomy implant technique
ThoracotomyProcedure or surgery
Thoracotomy implant technique
| Study group | Role | What they receive |
|---|---|---|
| HeartWare HVAD via Thoracotomy | Experimental | HeartWare HVAD implanted via thoracotomy Receives: Device: HeartWare HVAD; Procedure: Thoracotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject is Alive on Original Device, Transplanted, or Explanted for Recovery at 6 Months
- 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).
Measured: 6 months
Secondary outcomes (1)
Mean Length of Initial Hospital Stay
Mean length of initial hospital stay including both acute care (ICU/CCU) and step-down Care time
Measured: Initial Hospital Stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2014 (estimated)
- Study startNov 2014
- Primary completionOct 2016
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Left Sided Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- INTERMACS
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02268942
- Sponsor's protocol ID
- HW006 Thoracotomy
- Acronym
- HVAD
- Status last verified
- Nov 2019
- First submitted
- 16 Oct 2014
- Last updated
- 2 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
McGee E Jr, Danter M, Strueber M, Mahr C, Mokadam NA, Wieselthaler G, Klein L, Lee S, Boeve T, Maltais S, Pretorius GV, Adler E, Vassiliades T, Cheung A. Evaluation of a lateral thoracotomy implant approach for a centrifugal-flow left ventricular assist device: The LATERAL clinical trial. J Heart Lung Transplant. 2019 Apr;38(4):344-351. doi: 10.1016/j.healun.2019.02.002.
PubMed 30945636Wieselthaler GM, Klein L, Cheung AW, Danter MR, Strueber M, Mahr C, Mokadam NA, Maltais S, McGee EC Jr. Two-Year Follow Up of the LATERAL Clinical Trial: A Focus on Adverse Events. Circ Heart Fail. 2021 Apr;14(4):e006912. doi: 10.1161/CIRCHEARTFAILURE.120.006912. Epub 2021 Apr 19.
PubMed 33866829Mahr C, McGee E Jr, Cheung A, Mokadam NA, Strueber M, Slaughter MS, Danter MR, Levy WC, Cheng RK, Beckman JA, May DM, Ismyrloglou E, Tsintzos SI, Silvestry SC. Cost-Effectiveness of Thoracotomy Approach for the Implantation of a Centrifugal Left Ventricular Assist Device. ASAIO J. 2020 Aug;66(8):855-861. doi: 10.1097/MAT.0000000000001209.
PubMed 32740343
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Arm, Multi-Center Study in Collaboration With INTERMACS to Evaluate the Thoracotomy Implant Technique of the HeartWare™ HVAD™ System in Patients With Advanced Heart Failure
- ClinicalTrials.gov ID
- NCT02268942
- Acronym / sponsor ID
- HVAD / HW006 Thoracotomy
- Conditions
- Left Sided Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Collaborators
- INTERMACS
- Study start
- Nov 2014
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 20 Oct 2014 (estimated)
- Results
- Posted 12 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HeartWare HVAD via Thoracotomy | Experimental | Device: HeartWare HVAD, Procedure: ThoracotomyHeartWare HVAD implanted via thoracotomy |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Must be ≥19 years of age at time of informed consent to participate in the Intermacs® registry.
- Subject receives a HeartWare HVAD (The device should be the subject's first VAD implant).
- Subject signed an Intermacs® informed consent if required by local IRB policy.
- Subject signed a HeartWare informed consent.
Key exclusion criteria (14 listed)
- Subject is incarcerated (prisoner).
- Subject did not sign the informed consent at sites where waiver of consent was not granted.
- Body Surface Area (BSA) < 1.2 m^2.
- Prior cardiac transplant or cardiomyoplasty.
- Subject is receiving a BiVAD.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HeartWare HVADImplant of HeartWare HVAD via thoracotomy implant technique | Device | HeartWare HVAD via Thoracotomy |
| ThoracotomyThoracotomy implant technique | Procedure or surgery | HeartWare HVAD via Thoracotomy |
Primary outcome
Subject is Alive on Original Device, Transplanted, or Explanted for Recovery at 6 Months
Time frame: 6 months
* 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).
1 secondary outcome
Mean Length of Initial Hospital Stay
Time frame: Initial Hospital Stay
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 30945636McGee E Jr, Danter M, Strueber M, Mahr C, Mokadam NA, Wieselthaler G, Klein L, Lee S, Boeve T, Maltais S, Pretorius GV, Adler E, Vassiliades T, Cheung A. Evaluation of a lateral thoracotomy implant approach for a centrifugal-flow left ventricular assist device: The LATERAL clinical trial. J Heart Lung Transplant. 2019 Apr;38(4):344-351. doi: 10.1016/j.healun.2019.02.002.
- Derived from this study: PubMed 33866829Wieselthaler GM, Klein L, Cheung AW, Danter MR, Strueber M, Mahr C, Mokadam NA, Maltais S, McGee EC Jr. Two-Year Follow Up of the LATERAL Clinical Trial: A Focus on Adverse Events. Circ Heart Fail. 2021 Apr;14(4):e006912. doi: 10.1161/CIRCHEARTFAILURE.120.006912. Epub 2021 Apr 19.
- Derived from this study: PubMed 32740343Mahr C, McGee E Jr, Cheung A, Mokadam NA, Strueber M, Slaughter MS, Danter MR, Levy WC, Cheng RK, Beckman JA, May DM, Ismyrloglou E, Tsintzos SI, Silvestry SC. Cost-Effectiveness of Thoracotomy Approach for the Implantation of a Centrifugal Left Ventricular Assist Device. ASAIO J. 2020 Aug;66(8):855-861. doi: 10.1097/MAT.0000000000001209.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
26 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HeartWare HVAD and Thoracotomy in people with Left Sided Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 26 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subject is Alive on Original Device, Transplanted, or Explanted for Recovery at 6 Months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02268942, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2019.