Study Results
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View full resultsBasic Information
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TERMINATED
NA
44 participants
INTERVENTIONAL
2012-12-31
2014-03-31
Brief Summary
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The CRT pacemaker being studied in this clinical trial is approved by the US Food and Drug Administration (FDA) for patients with moderate to severe heart failure, whose hearts pump blood inefficiently. In the MIRACLE EF study, patients who have heart failure with slightly less inefficient hearts will be observed to see if the electrical pacing treatment is better than not getting the treatment. This study is being conducted to support FDA approval of this type of pacemaker for people whose heart failure is less inefficient.
Detailed Description
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Following enrollment and the baseline assessment, eligible subjects will be implanted with a CRT-P system and randomized in a 2:1 fashion to either treatment (CRT-P ON) or control (CRT-P OFF) groups. Study subjects will be followed for a minimum of 24 months or until study closure, and will remain in their randomized groups until their 60 month visit or until the study is stopped, whichever comes first. The effectiveness of CRT-P in this population will be assessed using a composite endpoint of time to first event, with event defined as All-cause mortality or HF Event. To assess the safety of CRT-P in this population, the primary safety endpoint will measure freedom from system-related complications at 6 months post-implant.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CRT-P ON
CRT-P Implant CRT-P ON
CRT-P Implant
The Medtronic Consulta CRT-P (models C3TR01, C4TR011) dual chamber implantable pacemaker with cardiac resynchronization therapy (CRT-P) is a multi-programmable cardiac device that monitors and regulates the patient's heart rate by providing single or dual chamber rate-responsive bradycardia pacing, and sequential biventricular pacing.
The device senses the electrical activity of the patient's heart using the electrodes of the implanted atrial and right ventricular leads. It then analyzes the heart rhythm based on selectable detection parameters. The device responds to bradyarrhythmias by providing bradycardia pacing therapy.
Simultaneous or sequential biventricular pacing is used to provide patients with cardiac resynchronization therapy. The device also provides diagnostic and monitoring information that assists with system evaluation and patient care.
CRT-P OFF
CRT-P Implant CRT-P OFF
CRT-P Implant
The Medtronic Consulta CRT-P (models C3TR01, C4TR011) dual chamber implantable pacemaker with cardiac resynchronization therapy (CRT-P) is a multi-programmable cardiac device that monitors and regulates the patient's heart rate by providing single or dual chamber rate-responsive bradycardia pacing, and sequential biventricular pacing.
The device senses the electrical activity of the patient's heart using the electrodes of the implanted atrial and right ventricular leads. It then analyzes the heart rhythm based on selectable detection parameters. The device responds to bradyarrhythmias by providing bradycardia pacing therapy.
Simultaneous or sequential biventricular pacing is used to provide patients with cardiac resynchronization therapy. The device also provides diagnostic and monitoring information that assists with system evaluation and patient care.
CRT-P OFF
Device programmed to minimal pacing at 40 beats/minute. Device and arrhythmia diagnostics may remain enabled.
Interventions
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CRT-P Implant
The Medtronic Consulta CRT-P (models C3TR01, C4TR011) dual chamber implantable pacemaker with cardiac resynchronization therapy (CRT-P) is a multi-programmable cardiac device that monitors and regulates the patient's heart rate by providing single or dual chamber rate-responsive bradycardia pacing, and sequential biventricular pacing.
The device senses the electrical activity of the patient's heart using the electrodes of the implanted atrial and right ventricular leads. It then analyzes the heart rhythm based on selectable detection parameters. The device responds to bradyarrhythmias by providing bradycardia pacing therapy.
Simultaneous or sequential biventricular pacing is used to provide patients with cardiac resynchronization therapy. The device also provides diagnostic and monitoring information that assists with system evaluation and patient care.
CRT-P OFF
Device programmed to minimal pacing at 40 beats/minute. Device and arrhythmia diagnostics may remain enabled.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has left ventricular ejection fraction (LVEF) between 36% and 50%, inclusive, as documented at baseline or within 30 days prior to enrollment
* Is either: (a) NYHA Class III at enrollment or at baseline OR (b) NYHA Class II at enrollment or at baseline, with a documented hospitalization for HF in the 12 months prior to enrollment OR (c) NYHA Class II at enrollment or at baseline, without a documented hospitalization for HF in the prior 12 months, but with BNP ≥250 pg/ml or NT-proBNP ≥1000 pg/ml
* Has documented left bundle branch block (LBBB) with QRS ≥130ms at baseline or within 30 days prior to enrollment.
* Is in sinus rhythm at time of enrollment or at the baseline visit.
* Has had no additions to or subtractions from non-diuretic heart failure medical therapy within 30 days prior to enrollment
* Is on maximum tolerated (guideline) dosages of medications in ACC/AHA guidelines for HF, Ischemic Heart Disease, Hypertension and AF as appropriate.
* Has signed and dated the study informed consent.
* Is able to receive a pectoral CRT-P implant.
* Is expected to remain available for follow-up visits.
* Is willing and able to comply with the Clinical Investigation Plan.
Exclusion Criteria
* Indicated for implantable cardioverter defibrillator (ICD), such as for secondary prevention of prior sudden cardiac arrest, related to prior history of ventricular tachycardia and/or ventricular fibrillation.
* Less than 18 years of age, or under a higher minimum age requirement as defined by local law.
* Unstable angina or an acute MI within 40 days prior to enrollment.
* Coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) within the 90 days prior to enrollment.
* Chronic (permanent) atrial arrhythmias. Chronic (permanent) atrial arrhythmias are defined as cases of long-standing atrial fibrillation (e.g., greater than 1 year) in which cardioversion has not been indicated or attempted.
* Cardioversion for atrial fibrillation within 30 days prior to enrollment.
* Treatable pericardial constraint within 30 days prior to enrollment.
* Restrictive (infiltrative) cardiomyopathies, such as amyloidosis, sarcoidosis, or hemochromatosis.
* Enrolled in a concurrent study, with the exception of a study-manager approved study that is strictly observational in nature and does not confound the results of this study (e.g. registries).
* Life expectancy of less than 24 months due to non-cardiac conditions.
* Pregnant, or of childbearing potential and not on a reliable form of birth control.
* CRT-P, pacemaker, ICD or CRT-D device implanted previously, or currently.
* Restrictive, hypertrophic, or reversible cardiomyopathy.
* Mechanical right heart valve.
* Primary valvular disease and is indicated for valve repair or replacement.
* Heart transplant, or is currently on a heart transplant list.
* Significant renal dysfunction, as manifested by serum creatinine level \>2.5 mg/dl or ≥275 μmol/L or estimated glomerular filtration rate (GFR) ≤30 mL/min/1.73 m2, which is documented within the 30 days prior to enrollment or at baseline.
* Significant hepatic dysfunction, as evidenced by a hepatic function panel (serum) \> 3 times upper limit of normal, which is documented within the 30 days prior to enrollment or at baseline.
* Chronic or treatment-resistant severe anemia (hemoglobin \<10.0 g/dL), which is documented within the 30 days prior to enrollment or at baseline.
* On intravenous inotropic drug therapy.
18 Years
ALL
No
Sponsors
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Medtronic Cardiac Rhythm and Heart Failure
INDUSTRY
Responsible Party
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Principal Investigators
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Cecilia Linde, MD PhD
Role: STUDY_CHAIR
Karolinska University Hospital
Locations
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John Muir Medical Center, Cor Cardiovascular Specialists, John Muir Medical Center (Concord), John Muir Cardiovascular Institute, Contra Costa Cardiology
Concord, California, United States
Scripps Clinic Torrey Pines, Scripps Green Hospital
La Jolla, California, United States
VA Greater Los Angeles Healthcare System
Los Angeles, California, United States
Eisenhower Desert Cardiology Center, Eisenhower Medical Center Hospital
Rancho Mirage, California, United States
Los Robles Medical Center
Thousand Oaks, California, United States
Colorado Health Medical Group, Memorial Hospital Colorado Springs
Colorado Springs, Colorado, United States
Hartford Hospital
Hartford, Connecticut, United States
Bradenton Cardiology, Manatee Memorial Hospital
Bradenton, Florida, United States
Melbourne Internal Medicine Associates / Century Research Associates, Holmes Regional Medical Center Hospital
Melbourne, Florida, United States
Aventura Hospital and Medical Center, Hospital Corporation of America (Aventura), Hospital Corporation of America (Miami)
Miami, Florida, United States
Emory University Hospital Midtown
Atlanta, Georgia, United States
WellStar Cobb Hospital, WellStar Kennestone Hospital
Marietta, Georgia, United States
Advocate Medical Group, Midwest Heart Specialists (Elmhurst), Elmhurst Memorial Hospital
Elmhurst, Illinois, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, United States
Prairie Education and Research Cooperative (Springfield IL), Prairie Education Research Consultants, St. John's Hospital (Springfield IL)
Springfield, Illinois, United States
McFarland Clinic PC
Ames, Iowa, United States
Cardiovascular Medicine PC (Davenport IA), Trinity (Rock Island), Midwest Cardiovascular Research Foundation, Trinity Bettendorf Hospital
Davenport, Iowa, United States
Midwest Cardiology Associates PA, Menorah Medical Center, Centerpoint Medical Center, Overland Park Regional Medical Center Hospital
Overland Park, Kansas, United States
Lahey Hospital & Medical Center
Burlington, Massachusetts, United States
Sparrow Clinical Research Institute, McLaren Hospital
Lansing, Michigan, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
HealthEast HeartCare Clinic at Saint John's
Maplewood, Minnesota, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States
The Cardiovascular Center, University of Minnesota Medical Center Fairview
Minneapolis, Minnesota, United States
North Memorial Heart and Vascular Institute, North Memorial Medical Center
Robbinsdale, Minnesota, United States
CentraCare Heart & Vascular Center
Saint Cloud, Minnesota, United States
Minneapolis Heart Institute Foundation, Mercy Hospital (Coon Rapids MN), Unity Hospital, United Hospital, Abbott Northwestern Hospital
Saint Paul, Minnesota, United States
Missouri Cardiovascular Specialists, Boone Hospital Center
Columbia, Missouri, United States
Cardiovascular Consultants, P.C., Saint Luke's Hospital, Mid America Heart Institute (MAHI)
Kansas City, Missouri, United States
Mercy Heart and Vascular Clinic, Mercy Hospital St. Louis
St Louis, Missouri, United States
Glacier View Research Institute Cardiology, Duplicate Glacier View Research Institute Hospital
Kalispell, Montana, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
New Mexico Heart Institute PA
Albuquerque, New Mexico, United States
Buffalo Heart Group LLP, Buffalo Heart Group LLC-Cheektowaga, Mercy Hospital of Buffalo
Buffalo, New York, United States
Stony Brook Islandia Clinic, Stony Brook Hauppauge, Stony Brook University Medical Center
Stony Brook, New York, United States
Duke University Medical Center (DUMC)
Durham, North Carolina, United States
Durham VA Medical Center, Duke University Medical Center
Durham, North Carolina, United States
FirstHealth Cardiology Services, FirstHealth Moore Regional Hospital
Pinehurst, North Carolina, United States
Forsyth Medical Center, Novant Clinical Research Institute
Winston-Salem, North Carolina, United States
Sanford Medical Center
Fargo, North Dakota, United States
Lindner Research Center, The Christ Hospital
Cincinnati, Ohio, United States
Ohio State University, Ohio State University Medical Center The Richard M Ross Heart Hospital
Columbus, Ohio, United States
Mercy Hospital Fairfield, Mercy Hospital Anderson, The Jewish Hospital
Fairfield, Ohio, United States
Integris Baptist Medical Center
Oklahoma City, Oklahoma, United States
Samaritan Health Services
Corvallis, Oregon, United States
Oregon Health & Science University
Portland, Oregon, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, United States
Mercer Bucks Cardiology, Saint Mary Medical Center, Arrhythmia Institute Hospital
Newtown, Pennsylvania, United States
University of Pittsburgh Medical Center UPMC Presbyterian
Pittsburgh, Pennsylvania, United States
Cardiac Diagnostic Associates, York Hospital
York, Pennsylvania, United States
Pee Dee Cardiology, McLeod Regional Medical Center
Florence, South Carolina, United States
Arrhythmia Consultants (Greenville SC), Greenville Memorial Hospital
Greenville, South Carolina, United States
Cardiology Consultants PA, Spartanburg Regional Hospital
Spartanburg, South Carolina, United States
Wellmont CVA Heart Institute, Wellmont Holston Valley Medical Center
Kingsport, Tennessee, United States
Centennial Heart Cardiovascular Consultants LLC
Nashville, Tennessee, United States
Saint Thomas Research Institute LLC, Baptist Hospital
Nashville, Tennessee, United States
Amarillo Heart Group, Northwest Texas Hospital
Amarillo, Texas, United States
Cardiology Center of Amarillo, Northwest Texas Hospital
Amarillo, Texas, United States
HeartPlace Cardiology Research, Baylor Heart & Vascular Hospital
Dallas, Texas, United States
Methodist DeBakey Cardiology Associates, The Methodist Hospital
Houston, Texas, United States
Baylor Research Institute (Plano TX), Legacy Heart Center
Plano, Texas, United States
Scott & White Hospital
Temple, Texas, United States
Fletcher Allen Medical Center
Burlington, Vermont, United States
University of Virginia (UVA) Medical Center
Charlottesville, Virginia, United States
Centra Medical Group Stroobants Cardiovascular Center, Centra Lynchburg General Hospital
Lynchburg, Virginia, United States
Richmond Cardiology Associates, Bon Secours Memorial Regional Medical Center
Mechanicsville, Virginia, United States
Sentara Cardiovascular Specialist, Sentara Williamsburg Regional Medical Center, Sentara Norfolk General Hospital, Sentara Virginia Beach General Hospital
Norfolk, Virginia, United States
Harborview Medical Center, University of Washington (UW) Medical Center
Seattle, Washington, United States
Aurora Cardiovascular Services, Aurora Sinai Medical Center, Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, United States
Medanta-The Medicity
Haryāna, , India
Tyumen Cardiology Center
Tyumen, , Russia
Karolinska University Hospital
Stockholm, , Sweden
University Hospitals of Birmingham NHS Foundation Trust - Queen Elizabeth Hospital
Birmingham, , United Kingdom
Countries
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Other Identifiers
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MIRACLE EF
Identifier Type: -
Identifier Source: org_study_id