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| Name | Class |
|---|---|
| INTERMACS | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HeartWare HVAD via Thoracotomy | Experimental | HeartWare HVAD implanted via thoracotomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HeartWare HVAD | Device | Implant of HeartWare HVAD via thoracotomy implant technique |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subject is Alive on Original Device, Transplanted, or Explanted for Recovery at 6 Months |
| 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Length of Initial Hospital Stay | Mean length of initial hospital stay including both acute care (ICU/CCU) and step-down Care time | Initial Hospital Stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Alabama | Birmingham | Alabama | 35294 | United States | ||
| Stanford University School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30945636 | Result | 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. | |
| 33866829 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Per Protocol Population | Subjects meeting eligibility criteria and received an HVAD implanted via thoracotomy. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 24, 2018 | Oct 21, 2019 |
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| Thoracotomy | Procedure | Thoracotomy implant technique |
|
| 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 |
| Derived |
| 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. |
| 32740343 | Derived | 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Per Protocol Population | Subjects meeting eligibility criteria and received an HVAD implanted via thoracotomy. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | 1 subject refused to answer | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Height | Mean | Standard Deviation | centimeters |
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| Weight | Mean | Standard Deviation | kilograms |
| |||||||||||||||||
| Body Mass Index | Mean | Standard Deviation | kilograms per meters squared |
| |||||||||||||||||
| Body Surface Area | Mean | Standard Deviation | meters squared |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Subject is Alive on Original Device, Transplanted, or Explanted for Recovery at 6 Months |
| Posted | Count of Participants | Participants | 6 months |
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| Secondary | Mean Length of Initial Hospital Stay | Mean length of initial hospital stay including both acute care (ICU/CCU) and step-down Care time | Posted | Mean | Standard Deviation | days | Initial Hospital Stay |
|
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Intermacs Categories used for collection.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Per Protocol Population | Subjects meeting eligibility criteria and received an HVAD implanted via thoracotomy. | 20 | 144 | 134 | 144 | 44 | 144 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Major Bleeding | Blood and lymphatic system disorders | Intermacs 4.0 | Non-systematic Assessment |
| |
| Cardiac Arrhythmia | Cardiac disorders | Intermacs 4.0 | Non-systematic Assessment |
| |
| Device Malfunction/Failure and/or Pump Thrombus | Product Issues | Intermacs 4.0 | Non-systematic Assessment |
| |
| Hemolysis | Blood and lymphatic system disorders | Intermacs 4.0 | Non-systematic Assessment |
| |
| Infection | Infections and infestations | Intermacs 4.0 | Non-systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | Intermacs 4.0 | Non-systematic Assessment |
| |
| Neurological Dysfunction | Vascular disorders | Intermacs 4.0 | Non-systematic Assessment |
| |
| Right Heart Failure | Cardiac disorders | Intermacs 4.0 | Non-systematic Assessment |
| |
| Hepatic Dysfunction | Hepatobiliary disorders | Intermacs 4.0 | Non-systematic Assessment |
| |
| Hypertension | General disorders | Intermacs 4.0 | Non-systematic Assessment |
| |
| Pericardial Fluid Collection | General disorders | Intermacs 4.0 | Non-systematic Assessment |
| |
| Psychiatric Episode | Psychiatric disorders | Intermacs 4.0 | Non-systematic Assessment |
| |
| Renal Dysfunction | Renal and urinary disorders | Intermacs 4.0 | Non-systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Intermacs 4.0 | Non-systematic Assessment |
| |
| Arterial Non-CNS Thromboembolism | Cardiac disorders | Intermacs 4.0 | Non-systematic Assessment |
| |
| Venous Thromboembolism | Cardiac disorders | Intermacs 4.0 | Non-systematic Assessment |
| |
| Wound Dehiscence | General disorders | Intermacs 4.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Other | General disorders | Intermacs 4.0 | Non-systematic Assessment | "Other" is an adverse event term category in the Intermacs registry and no additional data was provided. |
|
In most cases, the contract allows the principal investigator to publish their data after the release of the multi-center publication (or one year after the conclusion of the study if no multi-center publication is submitted) following the sponsor review for (a) disclosure of confidential information, and (b) information that would impair the sponsor's ability to obtain patent protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mary Jacoski | Medtronic Cardiac Rhythm and Heart Failure | +15087390909 | mary.v.jacoski@medtronic.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 22, 2017 | Oct 21, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D013908 | Thoracotomy |
| ID | Term |
|---|---|
| D019616 | Thoracic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Male |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Categories |
|---|
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