Heart FailureROADMAPNCT01452802
Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device (LVAD) and Medical Management
An observational study of Heart Failure, run by Abbott Medical Devices at 52 sites in United States.
Trial summary
The purpose of this study is to evaluate and compare the effectiveness of the HeartMate II (HM II) Left Ventricular Assist Device (LVAD) support versus OMM in ambulatory NYHA Class IIIB/IV heart failure patients who are not dependent on intravenous inotropic support and who meet the FDA approved indications for HM II… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- HM II (HeartMate II LVAD) and OMM (Optimal Medical Management)
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 52 sitesUnited States
- Study dates
- Oct 2011to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HM II implanting centers and community/referral heart failure clinics
Who may be able to join
- NYHA Class IIIB/IV (refer to Appendix IV for definitions)
- Left ventricular ejection fraction (LVEF) ≤ 25%
- Not currently listed for heart transplantation, and not planned in next 12 months
- On optimal medical management
- Limited functional status as demonstrated by 6MWT <300 meters
- At least:
- One hospitalization for HF in last 12 months or
- At least 2 unscheduled emergency room or infusion clinic visits (may include intravenous diuretic therapy, etc.) for HF in last 12 months
Who cannot join
- Presence of mechanical aortic or mitral valve, including planned conversion to bioprosthesis
- Platelet count < 100,000/mi within 48 prior to enrollment
- Any inotrope use within 30 days prior to enrollment
- Inability to perform 6MWT for any reason
- Any condition, other than heart failure, that could limit survival to less than 2 years
- History of cardiac or other organ transplant
Show all 12Show fewer
- Existence of any ongoing mechanical circulatory support (including intraaortic balloon pump, temporary circulatory support devices, etc.) at the time of enrollment
- Presence of active, uncontrolled, systemic infection
- History of an unresolved stroke within 90 days prior to enrollment, or a history of cerebral vascular disease with significant (> 80%)extracranial stenosis
- Contraindication to anticoagulation/antiplatelet therapy
- CRT or CRT-D within 3 months prior to enrollment
- Coronary revascularization (e.g. CABG, PCI) within 3 months prior to enrollment
Trial locations and contacts
52 sites in 1 country.
52 sites in 1 country
United States52 sites
Abington Memorial Hospital
Abington, Pennsylvania, 19001
New Mexico Heart Institute
Albuquerque, New Mexico, 87102
Emory University Hospital
Atlanta, Georgia, 30322
St. Joseph's Hospital / Atlanta
Atlanta, Georgia, 30342
Cedars Sinai Medical Center
Beverly Hills, California, 90211
University of North Carolina
Chapel Hill, North Carolina, 27599
University of Chicago Medical Center
Chicago, Illinois, 60637
The Metro Health System
Cleveland, Ohio, 44109
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Ohio State University Medical Center
Columbus, Ohio, 43210
Riverside Methodist Hospital
Columbus, Ohio, 43214
Baylor University Medical Center
Dallas, Texas, 75226
Henry Ford Hospital
Detroit, Michigan, 48202
Duke University Medical Center
Durham, North Carolina, 27710
Inova Fairfax Hospital
Falls Church, Virginia, 22042
Virginia Heart
Falls Church, Virginia, 22042
Sanford Medical Center
Fargo, North Dakota, 58122
Shands Hospital at University of Florida
Gainesville, Florida, 35610
Penn State Milton Hershey Medical Center
Hershey, Pennsylvania, 17033
Memorial Hermann, TMC
Houston, Texas, 77030
Methodist Hospital
Houston, Texas, 77030
Texas Heart Institute
Houston, Texas, 77030
St. Vincent's Hospitals and Health Services
Indianapolis, Indiana, 46260
St. Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
Baptist Medical Center
Little Rock, Arkansas, 72205
Keck Medical Center of USC
Los Angeles, California, 90033
Jewish Hospital
Louisville, Kentucky, 40202
St. Luke's Medical Center
Milwaukee, Wisconsin, 53233
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
University of Minnesota Medical Center
Minneapolis, Minnesota, 55455
Yale New Haven Hospital
New Haven, Connecticut, 06510
Mt. Sinai Medical Center
New York, New York, 10029
Columbia University Medical Center
New York, New York, 10032
Newark Beth Israel Medical Center
Newark, New Jersey, 07112
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453
INTEGRIS Baptist Medical Center, Inc.
Oklahoma City, Oklahoma, 73112
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Oregon Health and Science University
Portland, Oregon, 97239
Hudson Valley Heart Center
Poughkeepsie, New York, 12601
Virginia Commonwealth University
Richmond, Virginia, 23298
Mercer Bucks Cardiology
Robbinsville, New Jersey, 08691
Mayo Clinic Rochester
Rochester, Minnesota, 55905
University of Rochester Medical Center
Rochester, New York, 14642
University of Utah Medical School
Salt Lake City, Utah, 84132
Sharp Memorial Hospital
San Diego, California, 92123
University of Washington Medical Center
Seattle, Washington, 98195
Barnes Jewish Hospital
St Louis, Missouri, 63110
Stanford University
Stanford, California, 94305
Tampa General Hospital
Tampa, Florida, 33606
Montefiore Medical Center
The Bronx, New York, 10467
St. John Medical Center
Tulsa, Oklahoma, 74104
Michigan Heart
Ypsilanti, Michigan, 48197
About this study
Official title: Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients
The purpose of this study is to evaluate and compare the effectiveness of the HeartMate II (HM II) Left Ventricular Assist Device (LVAD) support versus OMM in ambulatory NYHA Class IIIB/IV heart failure patients who are not dependent on intravenous inotropic support and who meet the FDA approved indications for HM II LVAD destination therapy.
Read the detailed description
The HeartMate II (HM II) LVAD is approved by the U.S. Food and Drug Administration (FDA) for use in destination therapy (DT) patients with New York Heart Association (NYHA) Class IIIB/IV symptoms.
The ROADMAP trial is a prospective, multi-center, non-randomized, controlled, observational study that is designed to evaluate the effectiveness of HM II LVAD support versus optimal medical management (OMM) in ambulatory NYHA Class IIIB/IV heart failure patients who are not dependent on intravenous inotropic support and who meet the FDA approved indications for HM II LVAD destination therapy. Subjects will be enrolled in one of two cohorts: OMM or LVAD. Together with the investigator, the subjects will decide which cohort to enter into at their baseline visit. This study will include experienced HM II LVAD implant centers as well as community centers that care for a large volume of heart failure patients. Study patients will be followed for up to 24 months post enrollment for survival, quality of life and functional status.
- Conditions
- Heart Failure
- Being tested
- HM II (HeartMate II LVAD), OMM (Optimal Medical Management)
- Keywords
- HeartMate II, heart-assist device, medical management, optimal medical management, Heart Failure NYHA Class IIIB/IV, Thoratec Corporation
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HM II (HeartMate II LVAD)Device
Also called Left Ventricular Assist Device
The HM II pump contains a single moving component, the rotor. The pump is implanted just below the left hemidiaphragm with the inflow attached to the apex of the left ventricle and the outflow graft anastomosed to the ascending aorta. Blood is pumped continuously throughout the cardiac cycle from the left ventricle to the aorta.
OMM (Optimal Medical Management)Drug
Also called Medical Management
Optimal medical management per established heart failure guidelines for this subject population including ACE inhibitors, beta blockers and aldosterone antagonists 45 out of the last 60 days or an inability to tolerate neurohormonal antagonists.
| Study group | Role | What they receive |
|---|---|---|
| HM II (HeartMate II LVAD) | Subjects who elect to, and receive HM II LVAD therapy at baseline Receives: Device: HM II (HeartMate II LVAD) | |
| OMM (Optimal Medical Management) | Subjects who elect to remain on optimal medical management Receives: Drug: OMM (Optimal Medical Management) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of survival with improvement in Six Minute Hallway Walk Test distance from baseline of ≥ 75m.
Measured: 12 months
Secondary outcomes (9)
Risk stratified subgroup analysis of the primary endpoint and temporal analysis of primary endpoint.
Measured: 6, 12, 18, and 24 months
Accuracy of prognostic survival risk models including Seattle Heart Failure Model (SHFM) and HeartMate II Risk Score (HMRS)
Measured: Baseline and 6, 12, 18 and 24 months
Actuarial survival and survival free of stroke: a) intent-to-treat; and b) as treated.
Measured: 24 months
Survival in LVAD group free of pump replacement.
Measured: 24 months
Quality of Life using the EQ-5D-5L Health Utility Index.
Measured: Baseline and 6, 12, 18 and 24 months
Depression using Patient Health Questionnaire-9 (PHQ-9).
Measured: Baseline and 6, 12, 18 and 24 months
Questionnaire on patient decisions related to LVAD therapy versus optimal medical management.
Measured: Baseline and 6, 12, 18 and 24 months
Functional status using 6MWT distance and NYHA Classification
Measured: Baseline and 6, 12, 18 and 24 months
Incidence of adverse events, rehospitalizations, days alive and not hospitalized.
Measured: 3, 6, 9, 12, 15, 18, 21 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionMar 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Thoratec Corporation
- Responsible party
- Sponsor
- Investigators
- David Farrar, PhD, Study director, Abbott Medical Devices
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01452802
- Sponsor's protocol ID
- TC07272011
- Acronym
- ROADMAP
- Status last verified
- Jun 2022
- First submitted
- 12 Oct 2011
- Last updated
- 24 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Stehlik J, Estep JD, Selzman CH, Rogers JG, Spertus JA, Shah KB, Chuang J, Farrar DJ, Starling RC; ROADMAP Study Investigators. Patient-Reported Health-Related Quality of Life Is a Predictor of Outcomes in Ambulatory Heart Failure Patients Treated With Left Ventricular Assist Device Compared With Medical Management: Results From the ROADMAP Study (Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management). Circ Heart Fail. 2017 Jun;10(6):e003910. doi: 10.1161/CIRCHEARTFAILURE.116.003910.
PubMed 28611126Lanfear DE, Levy WC, Stehlik J, Estep JD, Rogers JG, Shah KB, Boyle AJ, Chuang J, Farrar DJ, Starling RC. Accuracy of Seattle Heart Failure Model and HeartMate II Risk Score in Non-Inotrope-Dependent Advanced Heart Failure Patients: Insights From the ROADMAP Study (Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients). Circ Heart Fail. 2017 May;10(5):e003745. doi: 10.1161/CIRCHEARTFAILURE.116.003745.
PubMed 28465311Starling RC, Estep JD, Horstmanshof DA, Milano CA, Stehlik J, Shah KB, Bruckner BA, Lee S, Long JW, Selzman CH, Kasirajan V, Haas DC, Boyle AJ, Chuang J, Farrar DJ, Rogers JG; ROADMAP Study Investigators. Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients: The ROADMAP Study 2-Year Results. JACC Heart Fail. 2017 Jul;5(7):518-527. doi: 10.1016/j.jchf.2017.02.016. Epub 2017 Apr 5.
PubMed 28396040Estep JD, Starling RC, Horstmanshof DA, Milano CA, Selzman CH, Shah KB, Loebe M, Moazami N, Long JW, Stehlik J, Kasirajan V, Haas DC, O'Connell JB, Boyle AJ, Farrar DJ, Rogers JG; ROADMAP Study Investigators. Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients: Results From the ROADMAP Study. J Am Coll Cardiol. 2015 Oct 20;66(16):1747-1761. doi: 10.1016/j.jacc.2015.07.075.
PubMed 26483097
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients
- ClinicalTrials.gov ID
- NCT01452802
- Acronym / sponsor ID
- ROADMAP / TC07272011
- Conditions
- Heart Failure
- Keywords
- HeartMate II, heart-assist device, medical management, optimal medical management, Heart Failure NYHA Class IIIB/IV, Thoratec Corporation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Collaborators
- Thoratec Corporation
- Study start
- Oct 2011
- Primary completion
- Mar 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 17 Oct 2011 (estimated)
- Results
- Not posted in the source record
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 and compare the effectiveness of the HeartMate II (HM II) Left Ventricular Assist Device (LVAD) support versus OMM in ambulatory NYHA Class IIIB/IV heart failure patients who are not dependent on intravenous inotropic support and who meet the FDA approved indications for HM II LVAD destination therapy.
Detailed description
The HeartMate II (HM II) LVAD is approved by the U.S. Food and Drug Administration (FDA) for use in destination therapy (DT) patients with New York Heart Association (NYHA) Class IIIB/IV symptoms.
The ROADMAP trial is a prospective, multi-center, non-randomized, controlled, observational study that is designed to evaluate the effectiveness of HM II LVAD support versus optimal medical management (OMM) in ambulatory NYHA Class IIIB/IV heart failure patients who are not dependent on intravenous inotropic support and who meet the FDA approved indications for HM II LVAD destination therapy. Subjects will be enrolled in one of two cohorts: OMM or LVAD. Together with the investigator, the subjects will decide which cohort to enter into at their baseline visit. This study will include experienced HM II LVAD implant centers as well as community centers that care for a large volume of heart failure patients. Study patients will be followed for up to 24 months post enrollment for survival, quality of life and functional status.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HM II (HeartMate II LVAD) | – | Device: HM II (HeartMate II LVAD)Subjects who elect to, and receive HM II LVAD therapy at baseline |
| OMM (Optimal Medical Management) | – | Drug: OMM (Optimal Medical Management)Subjects who elect to remain on optimal medical management |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HM II implanting centers and community/referral heart failure clinics
Key inclusion criteria (8 listed)
- NYHA Class IIIB/IV (refer to Appendix IV for definitions)
- Left ventricular ejection fraction (LVEF) ≤ 25%
- Not currently listed for heart transplantation, and not planned in next 12 months
- On optimal medical management
- Limited functional status as demonstrated by 6MWT <300 meters
Key exclusion criteria (12 listed)
- Presence of mechanical aortic or mitral valve, including planned conversion to bioprosthesis
- Platelet count < 100,000/mi within 48 prior to enrollment
- Any inotrope use within 30 days prior to enrollment
- Inability to perform 6MWT for any reason
- Any condition, other than heart failure, that could limit survival to less than 2 years
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 |
|---|---|---|
| HM II (HeartMate II LVAD)Also: Left Ventricular Assist DeviceThe HM II pump contains a single moving component, the rotor. The pump is implanted just below the left hemidiaphragm with the inflow attached to the apex of the left ventricle and the outflow graft anastomosed to the ascending aorta. Blood is pumped continuously throughout the cardiac cycle from the left ventricle to the aorta. | Device | HM II (HeartMate II LVAD) |
| OMM (Optimal Medical Management)Also: Medical ManagementOptimal medical management per established heart failure guidelines for this subject population including ACE inhibitors, beta blockers and aldosterone antagonists 45 out of the last 60 days or an inability to tolerate neurohormonal antagonists. | Drug | OMM (Optimal Medical Management) |
Primary outcome
Composite of survival with improvement in Six Minute Hallway Walk Test distance from baseline of ≥ 75m.
Time frame: 12 months
9 secondary outcomes
Risk stratified subgroup analysis of the primary endpoint and temporal analysis of primary endpoint.
Time frame: 6, 12, 18, and 24 months
Accuracy of prognostic survival risk models including Seattle Heart Failure Model (SHFM) and HeartMate II Risk Score (HMRS)
Time frame: Baseline and 6, 12, 18 and 24 months
Actuarial survival and survival free of stroke: a) intent-to-treat; and b) as treated.
Time frame: 24 months
Survival in LVAD group free of pump replacement.
Time frame: 24 months
Quality of Life using the EQ-5D-5L Health Utility Index.
Time frame: Baseline and 6, 12, 18 and 24 months
Depression using Patient Health Questionnaire-9 (PHQ-9).
Time frame: Baseline and 6, 12, 18 and 24 months
Questionnaire on patient decisions related to LVAD therapy versus optimal medical management.
Time frame: Baseline and 6, 12, 18 and 24 months
Functional status using 6MWT distance and NYHA Classification
Time frame: Baseline and 6, 12, 18 and 24 months
Incidence of adverse events, rehospitalizations, days alive and not hospitalized.
Time frame: 3, 6, 9, 12, 15, 18, 21 and 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2022.
- Derived from this study: PubMed 28611126Stehlik J, Estep JD, Selzman CH, Rogers JG, Spertus JA, Shah KB, Chuang J, Farrar DJ, Starling RC; ROADMAP Study Investigators. Patient-Reported Health-Related Quality of Life Is a Predictor of Outcomes in Ambulatory Heart Failure Patients Treated With Left Ventricular Assist Device Compared With Medical Management: Results From the ROADMAP Study (Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management). Circ Heart Fail. 2017 Jun;10(6):e003910. doi: 10.1161/CIRCHEARTFAILURE.116.003910.
- Derived from this study: PubMed 28465311Lanfear DE, Levy WC, Stehlik J, Estep JD, Rogers JG, Shah KB, Boyle AJ, Chuang J, Farrar DJ, Starling RC. Accuracy of Seattle Heart Failure Model and HeartMate II Risk Score in Non-Inotrope-Dependent Advanced Heart Failure Patients: Insights From the ROADMAP Study (Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients). Circ Heart Fail. 2017 May;10(5):e003745. doi: 10.1161/CIRCHEARTFAILURE.116.003745.
- Derived from this study: PubMed 28396040Starling RC, Estep JD, Horstmanshof DA, Milano CA, Stehlik J, Shah KB, Bruckner BA, Lee S, Long JW, Selzman CH, Kasirajan V, Haas DC, Boyle AJ, Chuang J, Farrar DJ, Rogers JG; ROADMAP Study Investigators. Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients: The ROADMAP Study 2-Year Results. JACC Heart Fail. 2017 Jul;5(7):518-527. doi: 10.1016/j.jchf.2017.02.016. Epub 2017 Apr 5.
- Derived from this study: PubMed 26483097Estep JD, Starling RC, Horstmanshof DA, Milano CA, Selzman CH, Shah KB, Loebe M, Moazami N, Long JW, Stehlik J, Kasirajan V, Haas DC, O'Connell JB, Boyle AJ, Farrar DJ, Rogers JG; ROADMAP Study Investigators. Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients: Results From the ROADMAP Study. J Am Coll Cardiol. 2015 Oct 20;66(16):1747-1761. doi: 10.1016/j.jacc.2015.07.075.
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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.
David Farrar, PhD study director
Abbott Medical Devices
52 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Abbott Medical Devices at 52 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 8 inclusion and 12 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 24 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 52 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Composite of survival with improvement in Six Minute Hallway Walk Test distance from baseline of ≥ 75m. (time frame: 12 months). 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 NCT01452802, which also lists 4 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 24 Jun 2022.