Chronic Heart FailureADVANCENCT00751972
Evaluation of the HeartWare Left Ventricular Assist Device for the Treatment of Advanced Heart Failure
A study testing HeartWare® VAS in people with Chronic Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 35 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of the HeartWare® LVAD System in patients listed for cardiac transplantation with refractory, advanced heart failure at risk of death. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- HeartWare® VAS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 35 sitesUnited States
- Study dates
- Aug 2008to Aug 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be at least 18 years of age at enrollment.
- Body Surface Area (BSA) greater than or equal to 1.2 m2.
- Patient is NYHA Class IV
- Patient listed for cardiac transplantation
- Patient meets United Network for Organ Sharing (UNOS) Status 1A or 1B listing criteria.
- HeartWare® LVAD implant is planned as a bridge to transplant
- The patient or legally authorized representative has signed the informed consent form
Who cannot join
- 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 enrollment.
- Acute myocardial infarction within 14 days of implant as diagnosed by ST or T wave changes on the ECG, diagnostic biomarkers, ongoing pain and hemodynamic abnormalities as described (Figure 2) in the guidelines published in ACC/AHA 2007 Guidelines for the Management of Patients with Unstable Angina/Non-ST-Elevation Myocardial Infarction; A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. JACC Vol. 50, No.7, 2007.
- On ventilator support for > 72 hours within the fours days immediately prior to enrollment.
Show all 25Show fewer
- Pulmonary embolus within three weeks of enrollment as documented by computed tomography (CT) scan or nuclear scan.
- Symptomatic cerebrovascular disease or a > 80% carotid stenosis.
- Patients have moderate to severe aortic insufficiency without plans for correction during pump implantation surgery.
- Patients with mechanical, animal or human tissue heart valves are excluded.
- Severe right ventricular failure as defined by the anticipated need for right ventricular assist device (RVAD) support or extracorporeal membrane oxygenation (ECMO)at the time of HeartWare® LVAD screening/enrollment or right atrial pressure > 20 mmHg on multiple inotropes, right ventricular ejection fraction (RVEF) <15% or clinical signs including lower extremity edema, ascites or pleural effusions refractory to treatment with diuretics and two inotropic drugs.
- Active, uncontrolled infection diagnosed by a combination of clinical symptoms and laboratory testing, including but not limited to, continued positive cultures, elevated temperature and white blood cell (WBC) count, hypotension, tachycardia, generalized malaise despite appropriate antibiotic, antiviral or antifungal treatment.
- Uncorrected thrombocytopenia or generalized coagulopathy (e.g., platelet count < 100,000, INR > 1.6 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 greater than 3.0 times the upper limit of normal within 48 hours of study enrollment or requiring dialysis (does not include use of ultra-filtration for fluid removal).
- All three listed liver enzymes [AST (SGOT), ALT (SGPT), or LDH] > 3 times upper limit of normal or a total bilirubin > 3 mg/dl within 24 hours of study enrollment, or biopsy proven liver cirrhosis or portal hypertension.
- Pulmonary vascular resistance is unresponsive (fixed) to pharmacologic manipulation as demonstrated by a pulmonary artery systolic pressure exceeding 60mmHg in conjunction with any one of the three following variables:
- Pulmonary vascular resistance is greater than 5 Woods Units or
- Pulmonary vascular resistance index is greater than 6 Woods Units or
- Transpulmonary gradient exceeds 16 to 20 mmHg
- Patients requiring aortic, mitral, tricuspid or pulmonary valve replacements (including bioprosthetic valves) or left ventricular (LV) aneurysm resections.
- Participation in any other study involving investigational drugs or devices.
- Severe illness, other than heart disease, which would exclude cardiac transplantation.
- Pregnancy.
- Patient unwilling or unable to comply with study requirements.
Trial locations and contacts
35 sites in 1 country.
35 sites in 1 country
United States35 sites
University of Michigan Hospital
Ann Arbor, Michigan, 48109
The Emory Clinic
Atlanta, Georgia, 30322
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Tufts Medical Center
Boston, Massachusetts, 02111
Northwestern Memorial Hospital
Chicago, Illinois, 60611
University of Chicago
Chicago, Illinois, 60637
Cleveland Clinic Foundatiojn
Cleveland, Ohio, 44195
Ohio State University Medical Center
Columbus, Ohio, 43210
UT Southwestern Medical Center at Dallas
Dallas, Texas, 75390
Henry Ford Hospital
Detroit, Michigan, 48202
Duke University Medical Center
Durham, North Carolina, 27710
Inova Fairfax Hospital
Falls Church, Virginia, 22042
University of Florida Gainesville
Gainesville, Florida, 32610
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Texas Heart Institute
Houston, Texas, 77030
The Methodist Hospital
Houston, Texas, 77030
IU Health Methodist
Indianapolis, Indiana, 46202
St. Vincent Health
Indianapolis, Indiana, 46260
Jewish Hospital - Rudd Heart and Lung Institute
Louisville, Kentucky, 40202
University of Miami / Jackson Memorial Hospital
Miami, Florida, 33136
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
University of Minnesota
Minneapolis, Minnesota, 55455
Intermountain Medical Center
Murray, Utah, 84107
John Ochsner Heart & Vascular Institute
New Orleans, Louisiana, 70115
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Mayo Clinic (Arizona)
Phoenix, Arizona, 85054
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Mayo Clinic / St. Marys Hospital
Rochester, Minnesota, 55902
Sharp Memorial Hospital
San Diego, California, 92123
Providence Sacred Heart Medical Center
Spokane, Washington, 99204
Washington University / Barnes Jewish Hospital
St Louis, Missouri, 63110
Stanford University School of Medicine
Stanford, California, 94305
Montefiore Medical Center
The Bronx, New York, 10467
Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
The purpose of this study is to evaluate the safety and effectiveness of the HeartWare® LVAD System in patients listed for cardiac transplantation with refractory, advanced heart failure at risk of death. The primary endpoint is survival at 180 days which is defined as alive on the originally implanted HeartWare® LVAD or transplanted or explanted for recovery. Patient must survive 60 days post-explant for recovery to be considered successful. Secondary endpoints include:
- Overall survival
- Incidence of all serious adverse events, neurocognitive status and unanticipated adverse device effects.
- Incidence of all device failures and device malfunctions
- Quality of Life improvement, as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) and EuroQoL EQ-5D
- Functional status improvement, as measured by the New York Heart Association (NYHA) and 6-minute walk
The HeartWare® LVAD System was approved by the US FDA on November 20, 2012 as a bridge to cardiac transplantation (reference PMA P100047). Patients enrolled into this study will be followed to an outcome at six months, and then patients will receive continued follow-up in a separate study.
- Conditions
- Chronic Heart Failure
- Being tested
- HeartWare® VAS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeartWare® VASDevice
The HeartWare® LVAD is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device which is both lightweight and simple to use.
| Study group | Role | What they receive |
|---|---|---|
| HeartWare® VAS | Experimental | Ventricular Assist Device (HeartWare® VAS) Receives: Device: HeartWare® VAS |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary Endpoint is Success at 180 Days Which is Defined as Alive on the Originally Implanted HeartWare® LVAD or Transplanted or Explanted for Recovery. Patient Must Survive 60 Days Post-explant for Recovery to be Considered Successful.
The primary endpoint is success at 180 days which is defined as alive on the originally implanted HeartWare® LVAD or transplanted or explanted for recovery. A patient must survive 60 days post-explant for recovery to be considered successful.
Measured: 180 days
Secondary outcomes (6)
Survival to 180 Days
All subjects will be followed for date of death until 180 days.
Measured: 180 Days
Incidence of Adverse Events, Neurocognitive Status and Unanticipated Adverse Device Effects
Adverse events are only provided for patients who received a HeartWare Ventricular Assist Device (HeartWare® VAS). Adverse events as described by INTERMACS for the contemporaneous control population were not a part of the agreement for analysis and thus not provided by INTERMACS, and so not included in the Adverse Event Module and relevant Outcome Measures for comparison.
Measured: 180 Days
Incidence of All Device Failures and Device Malfunctions
The INTERMACS event device malfunction defined a failure of the HeartWare VAS as either pump failure or non-pump failure.
Measured: 180 Days
Quality of Life Change From Baseline to 180 Days, as Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)
KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life for patients with congestive heart failure. It is a predictive tool that tracks how patients are doing if they have weakened heart muscle due to prior heart attacks, heart valve problems, viral infections, or other causes.
The KCCQ's questions are used to calculate scores in ten domains:
Physical Limitation, Symptom Stability, Frequency, Burden and Total Symptom. Social Limitation, Self-Efficacy, Quality of Life, and Clinical Summary. Overall Summary: a combined measure of all the above
For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Measured: Baseline and 180 Days
Change in Distance Walked in the 6-minute Walk Test Between Baseline and 180 Days
The 6MWT is a simple test which does not require expensive equipment or advanced training for technicians. The test involves asking the patient to walk the longest distance possible in a set interval of 6 min, through a walking course (corridor) preferably 30-m long. The patient can stop or slow down at any time and then resume walking, depending on his/her degree of fatigue.
A longer distance walked is indicative of a better outcome.
Measured: Baseline and 180 Days
Quality of Life Change From Baseline to 180 Days, as Measured by EuroQoL EQ-5D
The EQ-5D is a standardized instrument for use as a generic measure of the quality of health-related life and of health outcome.
The EuroQoL EQ-5D is a descriptive system of health-related quality of life states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of five responses. The responses record five levels of severity (no problems/slight problems/moderate problems/severe problems/extreme problems) within a particular EQ-5D dimension.
Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Measured: Baseline and 180 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2008 (estimated)
- Study startAug 2008
- Primary completionAug 2010
- Study completionAug 2013
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 (11)Papers the sponsor has linked to this study.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- More trials run by Medtronic Cardiac Rhythm and Heart FailureThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Slaughter, MD, Principal investigator, Jewish Hospital/Univ of LouisvilleKeith Aaronson, MD, Principal investigator, Univ of Michigan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00751972
- Sponsor's protocol ID
- HW003
- Acronym
- ADVANCE
- Status last verified
- May 2018
- First submitted
- 10 Sep 2008
- Last updated
- 30 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Aaronson KD, Slaughter MS, Miller LW, McGee EC, Cotts WG, Acker MA, Jessup ML, Gregoric ID, Loyalka P, Frazier OH, Jeevanandam V, Anderson AS, Kormos RL, Teuteberg JJ, Levy WC, Naftel DC, Bittman RM, Pagani FD, Hathaway DR, Boyce SW; HeartWare Ventricular Assist Device (HVAD) Bridge to Transplant ADVANCE Trial Investigators. Use of an intrapericardial, continuous-flow, centrifugal pump in patients awaiting heart transplantation. Circulation. 2012 Jun 26;125(25):3191-200. doi: 10.1161/CIRCULATIONAHA.111.058412. Epub 2012 May 22.
PubMed 22619284Mahr 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 32740343Silvestry 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.
PubMed 32740129Rahman F, McEvoy JW, Ohkuma T, Marre M, Hamet P, Harrap S, Mancia G, Rodgers A, Selvin E, Williams B, Muntner P, Chalmers J, Woodward M. Effects of Blood Pressure Lowering on Clinical Outcomes According to Baseline Blood Pressure and Cardiovascular Risk in Patients With Type 2 Diabetes Mellitus. Hypertension. 2019 Jun;73(6):1291-1299. doi: 10.1161/HYPERTENSIONAHA.118.12414.
PubMed 31030606Teuteberg JJ, Slaughter MS, Rogers JG, McGee EC, Pagani FD, Gordon R, Rame E, Acker M, Kormos RL, Salerno C, Schleeter TP, Goldstein DJ, Shin J, Starling RC, Wozniak T, Malik AS, Silvestry S, Ewald GA, Jorde UP, Naka Y, Birks E, Najarian KB, Hathaway DR, Aaronson KD; ADVANCE Trial Investigators. The HVAD Left Ventricular Assist Device: Risk Factors for Neurological Events and Risk Mitigation Strategies. JACC Heart Fail. 2015 Oct;3(10):818-28. doi: 10.1016/j.jchf.2015.05.011.
PubMed 26450000Birks EJ, McGee EC Jr, Aaronson KD, Boyce S, Cotts WG, Najjar SS, Pagani FD, Hathaway DR, Najarian K, Jacoski MV, Slaughter MS; ADVANCE Trial Investigators. An examination of survival by sex and race in the HeartWare Ventricular Assist Device for the Treatment of Advanced Heart Failure (ADVANCE) Bridge to Transplant (BTT) and continued access protocol trials. J Heart Lung Transplant. 2015 Jun;34(6):815-24. doi: 10.1016/j.healun.2014.12.011. Epub 2014 Dec 29.
PubMed 25813372Goldstein DJ, Aaronson KD, Tatooles AJ, Silvestry SC, Jeevanandam V, Gordon R, Hathaway DR, Najarian KB, Slaughter MS; ADVANCE Investigators. Gastrointestinal bleeding in recipients of the HeartWare Ventricular Assist System. JACC Heart Fail. 2015 Apr;3(4):303-13. doi: 10.1016/j.jchf.2014.11.008. Epub 2015 Mar 11.
PubMed 25770405Milano C, Pagani FD, Slaughter MS, Pham DT, Hathaway DR, Jacoski MV, Najarian KB, Aaronson KD; ADVANCE Investigators. Clinical outcomes after implantation of a centrifugal flow left ventricular assist device and concurrent cardiac valve procedures. Circulation. 2014 Sep 9;130(11 Suppl 1):S3-11. doi: 10.1161/CIRCULATIONAHA.113.007911.
PubMed 25200052John R, Aaronson KD, Pae WE, Acker MA, Hathaway DR, Najarian KB, Slaughter MS; HeartWare Bridge to Transplant ADVANCE Trial Investigators. Drive-line infections and sepsis in patients receiving the HVAD system as a left ventricular assist device. J Heart Lung Transplant. 2014 Oct;33(10):1066-73. doi: 10.1016/j.healun.2014.05.010. Epub 2014 Jun 4.
PubMed 25087103Najjar SS, Slaughter MS, Pagani FD, Starling RC, McGee EC, Eckman P, Tatooles AJ, Moazami N, Kormos RL, Hathaway DR, Najarian KB, Bhat G, Aaronson KD, Boyce SW; HVAD Bridge to Transplant ADVANCE Trial Investigators. An analysis of pump thrombus events in patients in the HeartWare ADVANCE bridge to transplant and continued access protocol trial. J Heart Lung Transplant. 2014 Jan;33(1):23-34. doi: 10.1016/j.healun.2013.12.001. Epub 2013 Dec 12.
PubMed 24418731Slaughter MS, Pagani FD, McGee EC, Birks EJ, Cotts WG, Gregoric I, Howard Frazier O, Icenogle T, Najjar SS, Boyce SW, Acker MA, John R, Hathaway DR, Najarian KB, Aaronson KD; HeartWare Bridge to Transplant ADVANCE Trial Investigators. HeartWare ventricular assist system for bridge to transplant: combined results of the bridge to transplant and continued access protocol trial. J Heart Lung Transplant. 2013 Jul;32(7):675-83. doi: 10.1016/j.healun.2013.04.004.
PubMed 23796152
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the HeartWare Left Ventricular Assist Device for the Treatment of Advanced Heart Failure
- ClinicalTrials.gov ID
- NCT00751972
- Acronym / sponsor ID
- ADVANCE / HW003
- Conditions
- Chronic Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 12 Sep 2008 (estimated)
- Results
- Posted 2 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and effectiveness of the HeartWare® LVAD System in patients listed for cardiac transplantation with refractory, advanced heart failure at risk of death. The primary endpoint is survival at 180 days which is defined as alive on the originally implanted HeartWare® LVAD or transplanted or explanted for recovery. Patient must survive 60 days post-explant for recovery to be considered successful. Secondary endpoints include:
- Overall survival
- Incidence of all serious adverse events, neurocognitive status and unanticipated adverse device effects.
- Incidence of all device failures and device malfunctions
- Quality of Life improvement, as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) and EuroQoL EQ-5D
- Functional status improvement, as measured by the New York Heart Association (NYHA) and 6-minute walk
The HeartWare® LVAD System was approved by the US FDA on November 20, 2012 as a bridge to cardiac transplantation (reference PMA P100047). Patients enrolled into this study will be followed to an outcome at six months, and then patients will receive continued follow-up in a separate study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HeartWare® VAS | Experimental | Device: HeartWare® VASVentricular Assist Device (HeartWare® VAS) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Must be at least 18 years of age at enrollment.
- Body Surface Area (BSA) greater than or equal to 1.2 m2.
- Patient is NYHA Class IV
- Patient listed for cardiac transplantation
- Patient meets United Network for Organ Sharing (UNOS) Status 1A or 1B listing criteria.
Key exclusion criteria (25 listed)
- 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 enrollment.
- Acute myocardial infarction within 14 days of implant as diagnosed by ST or T wave changes on the ECG, diagnostic biomarkers, ongoing pain and hemodynamic abnormalities as described (Figure 2) in the guidelines published in ACC/AHA 2007 Guidelines for the Management of Patients with Unstable Angina/Non-ST-Elevation Myocardial Infarction; A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. JACC Vol. 50, No.7, 2007.
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® VASThe HeartWare® LVAD is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device which is both lightweight and simple to use. | Device | HeartWare® VAS |
Primary outcome
The Primary Endpoint is Success at 180 Days Which is Defined as Alive on the Originally Implanted HeartWare® LVAD or Transplanted or Explanted for Recovery. Patient Must Survive 60 Days Post-explant for Recovery to be Considered Successful.
Time frame: 180 days
The primary endpoint is success at 180 days which is defined as alive on the originally implanted HeartWare® LVAD or transplanted or explanted for recovery. A patient must survive 60 days post-explant for recovery to be considered successful.
6 secondary outcomes
Survival to 180 Days
Time frame: 180 Days
Incidence of Adverse Events, Neurocognitive Status and Unanticipated Adverse Device Effects
Time frame: 180 Days
Incidence of All Device Failures and Device Malfunctions
Time frame: 180 Days
Quality of Life Change From Baseline to 180 Days, as Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time frame: Baseline and 180 Days
Change in Distance Walked in the 6-minute Walk Test Between Baseline and 180 Days
Time frame: Baseline and 180 Days
Quality of Life Change From Baseline to 180 Days, as Measured by EuroQoL EQ-5D
Time frame: Baseline and 180 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22619284Aaronson KD, Slaughter MS, Miller LW, McGee EC, Cotts WG, Acker MA, Jessup ML, Gregoric ID, Loyalka P, Frazier OH, Jeevanandam V, Anderson AS, Kormos RL, Teuteberg JJ, Levy WC, Naftel DC, Bittman RM, Pagani FD, Hathaway DR, Boyce SW; HeartWare Ventricular Assist Device (HVAD) Bridge to Transplant ADVANCE Trial Investigators. Use of an intrapericardial, continuous-flow, centrifugal pump in patients awaiting heart transplantation. Circulation. 2012 Jun 26;125(25):3191-200. doi: 10.1161/CIRCULATIONAHA.111.058412. Epub 2012 May 22.
- 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.
- Derived from this study: PubMed 32740129Silvestry 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.
- Derived from this study: PubMed 31030606Rahman F, McEvoy JW, Ohkuma T, Marre M, Hamet P, Harrap S, Mancia G, Rodgers A, Selvin E, Williams B, Muntner P, Chalmers J, Woodward M. Effects of Blood Pressure Lowering on Clinical Outcomes According to Baseline Blood Pressure and Cardiovascular Risk in Patients With Type 2 Diabetes Mellitus. Hypertension. 2019 Jun;73(6):1291-1299. doi: 10.1161/HYPERTENSIONAHA.118.12414.
- Derived from this study: PubMed 26450000Teuteberg JJ, Slaughter MS, Rogers JG, McGee EC, Pagani FD, Gordon R, Rame E, Acker M, Kormos RL, Salerno C, Schleeter TP, Goldstein DJ, Shin J, Starling RC, Wozniak T, Malik AS, Silvestry S, Ewald GA, Jorde UP, Naka Y, Birks E, Najarian KB, Hathaway DR, Aaronson KD; ADVANCE Trial Investigators. The HVAD Left Ventricular Assist Device: Risk Factors for Neurological Events and Risk Mitigation Strategies. JACC Heart Fail. 2015 Oct;3(10):818-28. doi: 10.1016/j.jchf.2015.05.011.
- Derived from this study: PubMed 25813372Birks EJ, McGee EC Jr, Aaronson KD, Boyce S, Cotts WG, Najjar SS, Pagani FD, Hathaway DR, Najarian K, Jacoski MV, Slaughter MS; ADVANCE Trial Investigators. An examination of survival by sex and race in the HeartWare Ventricular Assist Device for the Treatment of Advanced Heart Failure (ADVANCE) Bridge to Transplant (BTT) and continued access protocol trials. J Heart Lung Transplant. 2015 Jun;34(6):815-24. doi: 10.1016/j.healun.2014.12.011. Epub 2014 Dec 29.
- Derived from this study: PubMed 25770405Goldstein DJ, Aaronson KD, Tatooles AJ, Silvestry SC, Jeevanandam V, Gordon R, Hathaway DR, Najarian KB, Slaughter MS; ADVANCE Investigators. Gastrointestinal bleeding in recipients of the HeartWare Ventricular Assist System. JACC Heart Fail. 2015 Apr;3(4):303-13. doi: 10.1016/j.jchf.2014.11.008. Epub 2015 Mar 11.
- Derived from this study: PubMed 25200052Milano C, Pagani FD, Slaughter MS, Pham DT, Hathaway DR, Jacoski MV, Najarian KB, Aaronson KD; ADVANCE Investigators. Clinical outcomes after implantation of a centrifugal flow left ventricular assist device and concurrent cardiac valve procedures. Circulation. 2014 Sep 9;130(11 Suppl 1):S3-11. doi: 10.1161/CIRCULATIONAHA.113.007911.
- Derived from this study: PubMed 25087103John R, Aaronson KD, Pae WE, Acker MA, Hathaway DR, Najarian KB, Slaughter MS; HeartWare Bridge to Transplant ADVANCE Trial Investigators. Drive-line infections and sepsis in patients receiving the HVAD system as a left ventricular assist device. J Heart Lung Transplant. 2014 Oct;33(10):1066-73. doi: 10.1016/j.healun.2014.05.010. Epub 2014 Jun 4.
- Derived from this study: PubMed 24418731Najjar SS, Slaughter MS, Pagani FD, Starling RC, McGee EC, Eckman P, Tatooles AJ, Moazami N, Kormos RL, Hathaway DR, Najarian KB, Bhat G, Aaronson KD, Boyce SW; HVAD Bridge to Transplant ADVANCE Trial Investigators. An analysis of pump thrombus events in patients in the HeartWare ADVANCE bridge to transplant and continued access protocol trial. J Heart Lung Transplant. 2014 Jan;33(1):23-34. doi: 10.1016/j.healun.2013.12.001. Epub 2013 Dec 12.
- Derived from this study: PubMed 23796152Slaughter MS, Pagani FD, McGee EC, Birks EJ, Cotts WG, Gregoric I, Howard Frazier O, Icenogle T, Najjar SS, Boyce SW, Acker MA, John R, Hathaway DR, Najarian KB, Aaronson KD; HeartWare Bridge to Transplant ADVANCE Trial Investigators. HeartWare ventricular assist system for bridge to transplant: combined results of the bridge to transplant and continued access protocol trial. J Heart Lung Transplant. 2013 Jul;32(7):675-83. doi: 10.1016/j.healun.2013.04.004.
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Community Health Worker Nutrition Self-Management Support for Cardio-Kidney-Metabolic Health
Hypertension (HTN), CKD - Chronic Kidney Disease
RecruitingPhase 4
The Effects of Low-Dose Versus High-Dose Intravenous IRON Therapy With Ferric DerisomaltOSE in Patients With Chronic Heart Failure and Iron Deficiency
Heart Failure, Iron Deficiency
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingObservational study
Norepinephrine in the Management of General Anesthesia-Induced Arterial Hypotension in Chronic Heart Failure Patients
Hypotension
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.
Mark Slaughter, MD principal investigator
Jewish Hospital/Univ of Louisville
Keith Aaronson, MD principal investigator
Univ of Michigan Medical Center
35 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HeartWare® VAS in people with Chronic Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 35 sites in United States.
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 7 inclusion and 25 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 30 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States. 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 2 May 2014). 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?
The Primary Endpoint is Success at 180 Days Which is Defined as Alive on the Originally Implanted HeartWare® LVAD or Transplanted or Explanted for Recovery. Patient Must Survive 60 Days Post-explant for Recovery to be Considered Successful. (time frame: 180 days). 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 NCT00751972, which also lists 11 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 30 May 2018.