Back to resultsHW006 LATERAL Thoracotomy (HVAD)
Primary Purpose
Left Sided Heart Failure
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
HeartWare HVAD
Thoracotomy
Sponsored by
About this trial
This is an interventional treatment trial for Left Sided Heart Failure
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- The University of Alabama
- Stanford University School of Medicine
- UC San Diego
- UCSF Medical Center
- Washington Hospital Center
- Tampa Transplant Institute/Tampa General Hospital
- Northwestern Memorial Hospital
- Loyola University Medical Center
- IU Health Methodist
- St. Vincent Hospital
- Jewish Hospital - Rudd Heart and Lung Institute
- John Ochsner Heart & Vascular Institute
- Tufts Medical Center
- University of Michigan Hospital
- Spectrum Health
- Mayo Rochester - St. Mary's Hospital
- St. Luke's Hospital of Kansas City
- Duke University Medical Center
- Milton S. Hershey Medical Center
- Hospital of the University of Pennsylvania
- Allegheny General Hospital
- Vanderbilt University Medical Center
- Inova Fairfax Hospital
- Virginia Commonwealth University
- University of Washington Medical Center
- St. Paul's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HeartWare HVAD via Thoracotomy
Arm Description
HeartWare HVAD implanted via thoracotomy
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Mean Length of Initial Hospital Stay
Mean length of initial hospital stay including both acute care (ICU/CCU) and step-down Care time
Full Information
NCT ID
NCT02268942
First Posted
October 16, 2014
Last Updated
November 18, 2019
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
Collaborators
INTERMACS
1. Study Identification
Unique Protocol Identification Number
NCT02268942
Brief Title
HW006 LATERAL Thoracotomy
Acronym
HVAD
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiac Rhythm and Heart Failure
Collaborators
INTERMACS
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Left Sided Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
144 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HeartWare HVAD via Thoracotomy
Arm Type
Experimental
Arm Description
HeartWare HVAD implanted via thoracotomy
Intervention Type
Device
Intervention Name(s)
HeartWare HVAD
Intervention Description
Implant of HeartWare HVAD via thoracotomy implant technique
Intervention Type
Procedure
Intervention Name(s)
Thoracotomy
Intervention Description
Thoracotomy implant technique
Primary Outcome Measure Information:
Title
Subject is Alive on Original Device, Transplanted, or Explanted for Recovery at 6 Months
Description
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).
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Mean Length of Initial Hospital Stay
Description
Mean length of initial hospital stay including both acute care (ICU/CCU) and step-down Care time
Time Frame
Initial Hospital Stay
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Facility Information:
Facility Name
The University of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Stanford University School of Medicine
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
UC San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
UCSF Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Tampa Transplant Institute/Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
IU Health Methodist
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
St. Vincent Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46262
Country
United States
Facility Name
Jewish Hospital - Rudd Heart and Lung Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
John Ochsner Heart & Vascular Institute
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
University of Michigan Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Spectrum Health
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Mayo Rochester - St. Mary's Hospital
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
St. Luke's Hospital of Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-8802
Country
United States
Facility Name
Inova Fairfax Hospital
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298-0068
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195-6310
Country
United States
Facility Name
St. Paul's Hospital
City
Vancouver
State/Province
British Columbia
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
30945636
Citation
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.
Results Reference
result
PubMed Identifier
33866829
Citation
Wieselthaler 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.
Results Reference
derived
PubMed Identifier
32740343
Citation
Mahr 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. Erratum In: ASAIO J. 2021 Aug 1;67(8):e148.
Results Reference
derived
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HW006 LATERAL Thoracotomy
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