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The HeartWare™ Ventricular Assist System as Destination Therapy of Advanced Heart Failure: the ENDURANCE Trial (ENDURANCE)

Primary Purpose

Chronic Heart Failure

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

HeartWare® VAS

Control LVAD

About this trial

This is an interventional treatment trial for Chronic Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Must be ≥18 years of age at consent
Body Surface Area (BSA) ≥ 1.2 m2
Patients with advanced heart failure symptoms (New York Heart Association (NYHA) Class IIIB or IV) who are: (patient must meet one of the following) 3a. On optimal medical management, including dietary salt restriction and diuretics, for at least 45 out of the last 60 days and are failing to respond; or 3b. In NYHA Class III or NYHA Class IV heart failure for at least 14 days, and dependent on intra aortic balloon pump (IABP) for 7 days and/or inotropes for at least 14 days
Left ventricular ejection fraction ≤ 25%
LVAD implant is intended as destination therapy
Must be able to receive either the HeartWare® VAS or control LVAD
Female patients of childbearing potential must agree to use adequate contraceptive precautions for the duration of the study.
The patient or legally authorized representative has signed the informed consent form

Exclusion Criteria:

Body Mass Index (BMI) > 40
Existence of any ongoing mechanical circulatory support (MCS) other than an intra-aortic balloon pump (IABP)
Prior cardiac transplant.
History of confirmed, untreated abdominal or thoracic aortic aneurysm > 5 cm.
Cardiothoracic surgery within 30 days of randomization.
Acute myocardial infarction within 14 days of implant
Patients eligible for cardiac transplantation
On ventilator support for > 72 hours within the four days immediately prior to randomization and implant.
Pulmonary embolus within three weeks of randomization
Symptomatic cerebrovascular disease, stroke within 180 days of randomization or > 80% stenosis of carotid or cranial vessels.
Uncorrected moderate to severe aortic insufficiency. Correction may include repair or bioprosthesis at the time of implant.
Severe right ventricular failure as defined by the anticipated need for right ventricular assist device (RVAD) support or extracorporeal membrane oxygenation (ECMO) or right atrial pressure > 20 mmHg on multiple inotropes, right ventricular ejection fraction (RVEF) <15% or clinical signs
Active, uncontrolled infection diagnosed by a combination of clinical symptoms and laboratory testing.
Uncorrected thrombocytopenia or generalized coagulopathy (e.g., platelet count < 75,000, INR > 2.0 or PTT > 2.5 times control in the absence of anticoagulation therapy).
Intolerance to anticoagulant or antiplatelet therapies or any other peri- or postoperative therapy that the investigator may administer based upon the patient's health status.
Serum creatinine > 3.0 mg/dL within 72 hours of randomization or requiring dialysis (does not include use of ultra-filtration for fluid removal).
Specific liver enzymes [AST (SGOT) and ALT (SGPT)] > 3 times upper limit of normal within 72 hours of randomization.
A total bilirubin > 3 mg/dl within 72 hours of randomization, or biopsy proven liver cirrhosis or portal hypertension.
Pulmonary vascular resistance (PVR) is demonstrated to be unresponsive to pharmacological manipulation and the PVR > 6 Wood units.
Patients with a mechanical heart valve .
Etiology of heart failure is due to, or associated with, uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis, active myocarditis or restrictive cardiomyopathy
History of severe Chronic Obstructive Pulmonary Disease (COPD) or severe restrictive lung disease
Participation in any other study involving investigational drugs or devices
Severe illness, other than heart disease, which would limit survival to < 3 years
Peripheral vascular disease with rest pain or ischemic ulcers of the extremities
Pregnancy
Patient unwilling or unable to comply with study requirements
Technical obstacles, which pose an inordinately high surgical risk, in the judgment of the investigator

Sites / Locations

The University of Alabama at Birmingham
Mayo Clinic Hospital - Phoenix
The University of Southern California
Sharp Memorial
Stanford University School of Medicine
University of Colorado Hospital - Leprino
Washington Hospital Center
University of Florida - Gainesville
University of Miami/Jackson Memorial Hospital
Tampa Transplant Institute/Tampa General Hospital
The Emory Clinic Inc.
Saint Joseph Hospital of Atlanta
Northwestern Memorial Hospital
University of Chicago
Advocate Christ Medical Center
IU Health Methodist
Saint Vincent Health
Jewish Hospital
John Ochsner Heart & Vascular Institute
University of Maryland
Tufts Medical Center
University of Michigan Hospital
Henry Ford Hospital
Abbott Northwestern
University of Minnesota
St. Mary's Hospital - Mayo
Washington University/Barnes-Jewish Hospital
Newark Beth Israel Medical Center
Montefiore Medical Center
New York Presbyterian Hospital/Columbia
Duke University Medical Center
Cleveland Clinic Foundation
Ohio State University Medical Center
Oregon Health & Science University
Milton S. Hershey Medical Center
University of Pennsylvania Hospital
UPMC Presbyterian
Baylor University Medical Center
University of Texas - South Western
Texas Heart Institute
The Methodist Hospital
Intermountain Medical Center
University of Utah
Innova Heart and Vascular Institute Research - Cardiac Vascular & Thoracic Surgery Associates, PC
Sentara Norfolk
University of Washington Medical Center
Northwest Cardiothoracic &Transplant Surgeons
Saint Luke's Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HeartWare® VAS

Control LVAD

Arm Description

Implant of HeartWare® Ventricular Assist System

Implant of FDA-approved LVADs approved for destination therapy

Outcomes

Primary Outcome Measures

Stroke-Free Survival Probability for 2 Years Post Implant

The primary endpoint of the trial is stroke-free survival at two years, defined as alive on the originally implanted device, electively transplanted or explanted due to patient recovery and free from disabling stroke (Modified Rankin Scale >=4). The Modified Rankin Scale is scored from 0 to 6, where 0 indicates an absence of symptoms and 6 indicates death. A score of 4 or higher indicates moderately severe or greater disability. Weibull model estimates of survival probability (shown as a percent of 100) are used.

Secondary Outcome Measures

Number of Participants With Bleeding

Number of participants with bleeding, per Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) definition. The event of bleeding is defined as: An episode of suspected internal or external bleeding that results in one or more of the following: Death, Re-operation, Hospitalization, Transfusion of red blood cells as follows: During first 7 days post implant Adults (≥ 50 kg): ≥ 4U packed red blood cells (PRBC) within any 24 hour period during first 7 days post implant. After 7 days post implant Any transfusion of packed red blood cells (PRBC) after 7 days following implant.

Number of Participants With Major Infections

Number of participants with major infections, per INTERMACS definition. A major infection is defined as: A clinical infection accompanied by pain, fever, drainage and/or leukocytosis that is treated by anti-microbial agents (non-prophylactic). A positive culture from the infected site or organ should be present unless strong clinical evidence indicates the need for treatment despite negative cultures. The general categories of infection include Localized non-device infection Percutaneous site and/or pocket infection Internal pump component, inflow or outflow tract infection Sepsis

Overall Survival at 2 Years

Overall survival is the probability (expressed as a percent of 100) did not died within 2 years post implant via the Kaplan-Meier method. Participants that did not died were censored at the time of last follow-up or 2 years post implant, whichever occurred first.

Number of Participants With Device Malfunctions

Number of Participants with device malfunctions per INTERMACS definition. Device malfunction denotes a failure of one or more of the components of the Mechanical Circulatory Support Device (MCSD) system which either directly causes or could potentially induce a state of inadequate circulatory support (low cardiac output state) or death. The manufacturer must confirm device failure. A failure that was iatrogenic or recipient-induced will be classified as an Iatrogenic/Recipient-Induced Failure. Device failure should be classified according to which components fails as follows: Pump failure (blood contacting components of pump and any motor or other pump actuating mechanism that is housed with the blood contacting components). Non-pump failure (e.g., external pneumatic drive unit, electric power supply unit, batteries, controller, interconnect cable, compliance chamber)

Health Status Change Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)

Health Status change as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score. The KCCQ is a disease-specific patient-reported outcomes measure for patients with heart failure. It consists of 23 items, is comprised of 7 clinically relevant scales (Symptom Frequency, Symptom Burden, Symptom Stability, Physical Limitation, Social Limitation, Quality of Life, and Self-Efficacy), and yields 3 summary scores (Clinical Summary, Total Symptom, and Overall Summary Scores). Scale and summary scores range between 0 and 100, with higher scores indicating better health status (e.g., better functioning, fewer symptoms, better quality of life). The Overall Summary Score is calculated as the mean of the Physical Limitation, Total Symptom, Quality of Life and Social Limitation scores. A positive change in score from baseline indicates an improvement.

Health Status Change Measured by EuroQol EQ-5D (Version 3L)

The EuroQol-5D (version 3L) is a brief self-administered, validated instrument consisting of 2 parts. The second part consists of the EQ-5D general health status as measured by a visual analog scale (EQ-5D VAS). EQ-5D VAS measures the participant's self-rated health status on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state). An adjustment was done on the response where the scores were normalized based on this paper: Johnson JA, Coons SJ. Comparison of the EQ-5D and SF-12 in an adult US sample. Qual Life Res. 1998 Feb;7(2):155-66.

Change in Functional Status Measured by New York Heart Association (NYHA) Class

Change in Functional status, as measured by New York Heart Association (NYHA) class. There are 4 levels of NYHA: I (Mild): No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, or dyspnea. II (Mild): Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnea. III (Moderate): Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea. IV (Severe): Unable to carry out any physical activity without discomfort. Symptoms of cardiac insufficiency at rest. If any physical activity is undertaken, discomfort is increased. Improvement is defined as moving from a higher numerical NYHA level to a lower numerical NYHA level (e.g., IV to III).

Change in Functional Status as Measured by 6-minute Walk

Change in functional status, as measured by 6-minute walk test.

Length of Initial Hospitalization

Length of Initial Hospitalization post implant

Number of Participants Who Had a Re-hospitalization

Number of participants who had a re-hospitalization while on the device

Duration of Re-hospitalization

Duration of Re-hospitalization while on device

Cause of Re-hospitalization

Cause of Re-hospitalization while on device. The reason a participant may have been re-hospitalized was due to an adverse event, the need for an explant, or for various "Other" reasons.

Full Information

NCT ID

NCT01166347

First Posted

July 16, 2010

Last Updated

September 4, 2018

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

1. Study Identification

Unique Protocol Identification Number

NCT01166347

Brief Title

The HeartWare™ Ventricular Assist System as Destination Therapy of Advanced Heart Failure: the ENDURANCE Trial

Acronym

ENDURANCE

Official Title

A Prospective, Randomized, Controlled, Un-blinded, Multi-Center Clinical Trial to Evaluate the HeartWare™ Ventricular Assist System (VAS) for Destination Therapy of Advanced Heart Failure

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Completed

Study Start Date

August 2010 (undefined)

Primary Completion Date

May 2014 (Actual)

Study Completion Date

May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medtronic Cardiac Rhythm and Heart Failure

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to determine the safety and effectiveness of the HeartWare Ventricular Assist System in patients with chronic Stage D/ New York Heart Association (NYHA) Class IIIB/IV left ventricular failure who have received and failed optimal medical therapy, and who are ineligible for cardiac transplantation.

Detailed Description

The HeartWare Ventricular Assist System (VAS) is intended for use in patients with chronic Stage D/NYHA Class IIIB/IV left ventricular failure who have received and failed optimal medical therapy and who are ineligible for cardiac transplantation. The ENDURANCE clinical study is a prospective, randomized, unblinded, multi-center, non-inferiority evaluation of the HeartWare® VAS versus a control group consisting of any FDA-approved Left Ventricular Assist Device (LVAD) approved for destination therapy. Patients are randomized to HeartWare® VAS or control LVAD in a 2:1 ratio. Each patient receiving the HeartWare® VAS or control LVAD is followed to the primary endpoint at 2 years, with a subsequent follow-up period extending to 5 years post implant.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Heart Failure

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

451 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HeartWare® VAS

Arm Type

Experimental

Arm Description

Implant of HeartWare® Ventricular Assist System

Arm Title

Control LVAD

Arm Type

Active Comparator

Arm Description

Implant of FDA-approved LVADs approved for destination therapy

Intervention Type

Device

Intervention Name(s)

HeartWare® VAS

Intervention Description

The HeartWare® VAS is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device that is both lightweight and simple to use.

Intervention Type

Device

Intervention Name(s)

Control LVAD

Intervention Description

Any FDA-approved LVAD for destination therapy.

Primary Outcome Measure Information:

Title

Stroke-Free Survival Probability for 2 Years Post Implant

Description

Time Frame

Implant to 2 years

Secondary Outcome Measure Information:

Title

Number of Participants With Bleeding

Description

Time Frame

Implant to two years

Title

Number of Participants With Major Infections

Description

Time Frame

Implant to two years

Title

Overall Survival at 2 Years

Description

Time Frame

Implant to two years

Title

Number of Participants With Device Malfunctions

Description

Time Frame

Implant to two years

Title

Health Status Change Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)

Description

Time Frame

Change from baseline to 2 years

Title

Health Status Change Measured by EuroQol EQ-5D (Version 3L)

Description

Time Frame

Change from baseline to 2 years

Title

Change in Functional Status Measured by New York Heart Association (NYHA) Class

Description

Time Frame

Change from baseline to 2 years

Title

Change in Functional Status as Measured by 6-minute Walk

Description

Change in functional status, as measured by 6-minute walk test.

Time Frame

Change from baseline to 2 years

Title

Length of Initial Hospitalization

Description

Length of Initial Hospitalization post implant

Time Frame

Implant to the end of the initial hospitalization

Title

Number of Participants Who Had a Re-hospitalization

Description

Number of participants who had a re-hospitalization while on the device

Time Frame

Implant to two years

Title

Duration of Re-hospitalization

Description

Duration of Re-hospitalization while on device

Time Frame

Implant to two years

Title

Cause of Re-hospitalization

Description

Cause of Re-hospitalization while on device. The reason a participant may have been re-hospitalized was due to an adverse event, the need for an explant, or for various "Other" reasons.

Time Frame

Implant to two years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Must be ≥18 years of age at consent Body Surface Area (BSA) ≥ 1.2 m2 Patients with advanced heart failure symptoms (New York Heart Association (NYHA) Class IIIB or IV) who are: (patient must meet one of the following) 3a. On optimal medical management, including dietary salt restriction and diuretics, for at least 45 out of the last 60 days and are failing to respond; or 3b. In NYHA Class III or NYHA Class IV heart failure for at least 14 days, and dependent on intra aortic balloon pump (IABP) for 7 days and/or inotropes for at least 14 days Left ventricular ejection fraction ≤ 25% LVAD implant is intended as destination therapy Must be able to receive either the HeartWare® VAS or control LVAD Female patients of childbearing potential must agree to use adequate contraceptive precautions for the duration of the study. The patient or legally authorized representative has signed the informed consent form Exclusion Criteria: Body Mass Index (BMI) > 40 Existence of any ongoing mechanical circulatory support (MCS) other than an intra-aortic balloon pump (IABP) Prior cardiac transplant. History of confirmed, untreated abdominal or thoracic aortic aneurysm > 5 cm. Cardiothoracic surgery within 30 days of randomization. Acute myocardial infarction within 14 days of implant Patients eligible for cardiac transplantation On ventilator support for > 72 hours within the four days immediately prior to randomization and implant. Pulmonary embolus within three weeks of randomization Symptomatic cerebrovascular disease, stroke within 180 days of randomization or > 80% stenosis of carotid or cranial vessels. Uncorrected moderate to severe aortic insufficiency. Correction may include repair or bioprosthesis at the time of implant. Severe right ventricular failure as defined by the anticipated need for right ventricular assist device (RVAD) support or extracorporeal membrane oxygenation (ECMO) or right atrial pressure > 20 mmHg on multiple inotropes, right ventricular ejection fraction (RVEF) <15% or clinical signs Active, uncontrolled infection diagnosed by a combination of clinical symptoms and laboratory testing. Uncorrected thrombocytopenia or generalized coagulopathy (e.g., platelet count < 75,000, INR > 2.0 or PTT > 2.5 times control in the absence of anticoagulation therapy). Intolerance to anticoagulant or antiplatelet therapies or any other peri- or postoperative therapy that the investigator may administer based upon the patient's health status. Serum creatinine > 3.0 mg/dL within 72 hours of randomization or requiring dialysis (does not include use of ultra-filtration for fluid removal). Specific liver enzymes [AST (SGOT) and ALT (SGPT)] > 3 times upper limit of normal within 72 hours of randomization. A total bilirubin > 3 mg/dl within 72 hours of randomization, or biopsy proven liver cirrhosis or portal hypertension. Pulmonary vascular resistance (PVR) is demonstrated to be unresponsive to pharmacological manipulation and the PVR > 6 Wood units. Patients with a mechanical heart valve . Etiology of heart failure is due to, or associated with, uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis, active myocarditis or restrictive cardiomyopathy History of severe Chronic Obstructive Pulmonary Disease (COPD) or severe restrictive lung disease Participation in any other study involving investigational drugs or devices Severe illness, other than heart disease, which would limit survival to < 3 years Peripheral vascular disease with rest pain or ischemic ulcers of the extremities Pregnancy Patient unwilling or unable to comply with study requirements Technical obstacles, which pose an inordinately high surgical risk, in the judgment of the investigator

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Francis Pagani, MD

Organizational Affiliation

University of Michigan Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Joseph Rogers, MD

Organizational Affiliation

Duke University

Official's Role

Principal Investigator

Facility Information:

Facility Name

The University of Alabama at Birmingham

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294

Country

United States

Facility Name

Mayo Clinic Hospital - Phoenix

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85054

Country

United States

Facility Name

The University of Southern California

City

Los Angeles

State/Province

California

ZIP/Postal Code

90033

Country

United States

Facility Name

Sharp Memorial

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

Facility Name

Stanford University School of Medicine

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

Facility Name

University of Colorado Hospital - Leprino

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

Washington Hospital Center

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20010

Country

United States

Facility Name

University of Florida - Gainesville

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32610

Country

United States

Facility Name

University of Miami/Jackson Memorial Hospital

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

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

The Emory Clinic Inc.

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Facility Name

Saint Joseph Hospital of Atlanta

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30342

Country

United States

Facility Name

Northwestern Memorial Hospital

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Facility Name

University of Chicago

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637

Country

United States

Facility Name

Advocate Christ Medical Center

City

Oak Lawn

State/Province

Illinois

ZIP/Postal Code

60453

Country

United States

Facility Name

IU Health Methodist

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Facility Name

Saint Vincent Health

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46260

Country

United States

Facility Name

Jewish Hospital

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

University of Maryland

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21201

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

Henry Ford Hospital

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

Facility Name

Abbott Northwestern

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55407

Country

United States

Facility Name

University of Minnesota

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55455

Country

United States

Facility Name

St. Mary's Hospital - Mayo

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55902

Country

United States

Facility Name

Washington University/Barnes-Jewish Hospital

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Newark Beth Israel Medical Center

City

Newark

State/Province

New Jersey

ZIP/Postal Code

07112

Country

United States

Facility Name

Montefiore Medical Center

City

Bronx

State/Province

New York

ZIP/Postal Code

10467

Country

United States

Facility Name

New York Presbyterian Hospital/Columbia

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Facility Name

Duke University Medical Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Facility Name

Cleveland Clinic Foundation

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

Facility Name

Ohio State University Medical Center

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

Facility Name

Oregon Health & Science University

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Facility Name

Milton S. Hershey Medical Center

City

Hershey

State/Province

Pennsylvania

ZIP/Postal Code

17033

Country

United States

Facility Name

University of Pennsylvania Hospital

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

UPMC Presbyterian

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

Facility Name

Baylor University Medical Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75246

Country

United States

Facility Name

University of Texas - South Western

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390

Country

United States

Facility Name

Texas Heart Institute

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

The Methodist Hospital

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Intermountain Medical Center

City

Murray

State/Province

Utah

ZIP/Postal Code

84107

Country

United States

Facility Name

University of Utah

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84132

Country

United States

Facility Name

Innova Heart and Vascular Institute Research - Cardiac Vascular & Thoracic Surgery Associates, PC

City

Falls Church

State/Province

Virginia

ZIP/Postal Code

22042

Country

United States

Facility Name

Sentara Norfolk

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23507

Country

United States

Facility Name

University of Washington Medical Center

City

Seattle

State/Province

Washington

ZIP/Postal Code

98195

Country

United States

Facility Name

Northwest Cardiothoracic &Transplant Surgeons

City

Spokane

State/Province

Washington

ZIP/Postal Code

99204

Country

United States

Facility Name

Saint Luke's Medical Center

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53215

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

28146651

Citation

Rogers JG, Pagani FD, Tatooles AJ, Bhat G, Slaughter MS, Birks EJ, Boyce SW, Najjar SS, Jeevanandam V, Anderson AS, Gregoric ID, Mallidi H, Leadley K, Aaronson KD, Frazier OH, Milano CA. Intrapericardial Left Ventricular Assist Device for Advanced Heart Failure. N Engl J Med. 2017 Feb 2;376(5):451-460. doi: 10.1056/NEJMoa1602954.

Results Reference

result

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

PubMed Identifier

32740129

Citation

Silvestry SC, Mahr C, Slaughter MS, Levy WC, Cheng RK, May DM, Ismyrloglou E, Tsintzos SI, Tuttle E, Cook K, Birk E, Gomes A, Graham S, Cotts WG. Cost-Effectiveness of a Small Intrapericardial Centrifugal Left Ventricular Assist Device. ASAIO J. 2020 Aug;66(8):862-870. doi: 10.1097/MAT.0000000000001211. Erratum In: ASAIO J. 2021 Aug 1;67(8):e149.

Results Reference

derived

Learn more about this trial

The HeartWare™ Ventricular Assist System as Destination Therapy of Advanced Heart Failure: the ENDURANCE Trial

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