HW006 LATERAL Thoracotomy
HVAD
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
1 other identifier
interventional
144
2 countries
26
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2014
Longer than P75 for not_applicable
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 16, 2014
CompletedFirst Posted
Study publicly available on registry
October 20, 2014
CompletedStudy Start
First participant enrolled
November 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2018
CompletedResults Posted
Study results publicly available
November 12, 2019
CompletedDecember 2, 2019
November 1, 2019
1.9 years
October 16, 2014
October 22, 2019
November 18, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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).
6 months
Secondary Outcomes (1)
Mean Length of Initial Hospital Stay
Initial Hospital Stay
Study Arms (1)
HeartWare HVAD via Thoracotomy
EXPERIMENTALHeartWare HVAD implanted via thoracotomy
Interventions
Implant of HeartWare HVAD via thoracotomy implant technique
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medtronic Cardiac Rhythm and Heart Failurelead
- INTERMACScollaborator
Study Sites (26)
The University of Alabama
Birmingham, Alabama, 35294, United States
Stanford University School of Medicine
Palo Alto, California, 94305, United States
UC San Diego
San Diego, California, 92093, United States
UCSF Medical Center
San Francisco, California, 94143, United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Tampa Transplant Institute/Tampa General Hospital
Tampa, Florida, 33606, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
IU Health Methodist
Indianapolis, Indiana, 46202, United States
St. Vincent Hospital
Indianapolis, Indiana, 46262, United States
Jewish Hospital - Rudd Heart and Lung Institute
Louisville, Kentucky, 40202, United States
John Ochsner Heart & Vascular Institute
New Orleans, Louisiana, 70115, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
University of Michigan Hospital
Ann Arbor, Michigan, 48109, United States
Spectrum Health
Grand Rapids, Michigan, 49503, United States
Mayo Rochester - St. Mary's Hospital
Rochester, Minnesota, 55905, United States
St. Luke's Hospital of Kansas City
Kansas City, Missouri, 64111, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-8802, United States
Inova Fairfax Hospital
Falls Church, Virginia, 22042, United States
Virginia Commonwealth University
Richmond, Virginia, 23298-0068, United States
University of Washington Medical Center
Seattle, Washington, 98195-6310, United States
St. Paul's Hospital
Vancouver, British Columbia, Canada
Related Publications (3)
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.
PMID: 30945636RESULTWieselthaler 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.
PMID: 33866829DERIVEDMahr 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.
PMID: 32740343DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Mary Jacoski
- Organization
- Medtronic Cardiac Rhythm and Heart Failure
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 16, 2014
First Posted
October 20, 2014
Study Start
November 1, 2014
Primary Completion
October 1, 2016
Study Completion
October 1, 2018
Last Updated
December 2, 2019
Results First Posted
November 12, 2019
Record last verified: 2019-11