Clinical trial NCT01452802: Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device (LVAD) and Medical Management
Official title: Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: HeartMate II
heart-assist device
medical management
optimal medical management
Heart Failure NYHA Class IIIB/IV
Thoratec Corporation
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
Collaborators: name: Thoratec Corporation
First posted: 2011-10-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HM II implanting centers and community/referral heart failure clinics

Brief 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 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.

Eligibility criteria: The following are general criteria; more specific criteria are included in the study protocol:

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Composite of survival with improvement in Six Minute Hallway Walk Test distance from baseline of ≥ 75m.
timeFrame: 12 months
Secondary outcomes:
measure: Risk stratified subgroup analysis of the primary endpoint and temporal analysis of primary endpoint.
timeFrame: 6, 12, 18, and 24 months
measure: Accuracy of prognostic survival risk models including Seattle Heart Failure Model (SHFM) and HeartMate II Risk Score (HMRS)
timeFrame: Baseline and 6, 12, 18 and 24 months
measure: Actuarial survival and survival free of stroke: a) intent-to-treat; and b) as treated.
timeFrame: 24 months
measure: Survival in LVAD group free of pump replacement.
timeFrame: 24 months
measure: Quality of Life using the EQ-5D-5L Health Utility Index.
timeFrame: Baseline and 6, 12, 18 and 24 months
measure: Depression using Patient Health Questionnaire-9 (PHQ-9).
timeFrame: Baseline and 6, 12, 18 and 24 months
measure: Questionnaire on patient decisions related to LVAD therapy versus optimal medical management.
timeFrame: Baseline and 6, 12, 18 and 24 months
measure: Functional status using 6MWT distance and NYHA Classification
timeFrame: Baseline and 6, 12, 18 and 24 months
measure: Incidence of adverse events, rehospitalizations, days alive and not hospitalized.
timeFrame: 3, 6, 9, 12, 15, 18, 21 and 24 months
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Baptist Medical Center
state: Arkansas
city: Beverly Hills
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: Keck Medical Center of USC
state: California
city: San Diego
country: United States
facility: Sharp Memorial Hospital
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Gainesville
country: United States
facility: Shands Hospital at University of Florida
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Atlanta
country: United States
facility: St. Joseph's Hospital / Atlanta
state: Georgia
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Oak Lawn
country: United States
facility: Advocate Christ Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: St. Vincent's Hospitals and Health Services
state: Indiana
city: Louisville
country: United States
facility: Jewish Hospital
state: Kentucky
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Ypsilanti
country: United States
facility: Michigan Heart
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute Foundation
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: Kansas City
country: United States
facility: St. Luke's Hospital of Kansas City
state: Missouri
city: Saint Louis
country: United States
facility: Barnes Jewish Hospital
state: Missouri
city: Newark
country: United States
facility: Newark Beth Israel Medical Center
state: New Jersey
city: Robbinsville
country: United States
facility: Mercer Bucks Cardiology
state: New Jersey
city: Albuquerque
country: United States
facility: New Mexico Heart Institute
state: New Mexico
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: Mt. Sinai Medical Center
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Poughkeepsie
country: United States
facility: Hudson Valley Heart Center
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Fargo
country: United States
facility: Sanford Medical Center
state: North Dakota
city: Cleveland
country: United States
facility: The Metro Health System
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: Columbus
country: United States
facility: Riverside Methodist Hospital
state: Ohio
city: Oklahoma City
country: United States
facility: INTEGRIS Baptist Medical Center, Inc.
state: Oklahoma
city: Tulsa
country: United States
facility: St. John Medical Center
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Abington
country: United States
facility: Abington Memorial Hospital
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Milton Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
city: Houston
country: United States
facility: Memorial Hermann, TMC
state: Texas
city: Houston
country: United States
facility: Methodist Hospital
state: Texas
city: Houston
country: United States
facility: Texas Heart Institute
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Medical School
state: Utah
city: Falls Church
country: United States
facility: Inova Fairfax Hospital
state: Virginia
city: Falls Church
country: United States
facility: Virginia Heart
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Milwaukee
country: United States
facility: St. Luke's Medical Center
state: Wisconsin
Study officials:
affiliation: Abbott Medical Devices
name: David Farrar, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Lanfear 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.
citation: Starling 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.
citation: Estep 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.