MIRACLE EF Clinical Study

Stopped early · Not applicable

Conditions studied: Congestive Heart Failure, Left Bundle Branch Block, Systolic Heart Failure

In brief

This study is looking at whether the electrical treatment provided by a special type of pacemaker called a Cardiac Resynchronization Therapy (CRT) pacemaker may keep a patient's heart failure from getting worse. When the lower heart chambers (i.e. ventricles) are electrically paced to beat together by the CRT pacemaker, blood may be pumped to the body more efficiently. 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.

Key facts

Study ID

NCT01735916

Run by

Medtronic Cardiac Rhythm and Heart Failure

People needed

44

Starts

2012-12-01

Expected to finish

2014-03-01

Last updated by the study team

2017-11-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient has diagnosis of chronic heart failure > 90 days in duration
• 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.

You may not qualify if…

• Requires permanent cardiac pacing.
• 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.

Where it is running

• 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
• John Muir Medical Center, Cor Cardiovascular Specialists, John Muir Medical Center (Concord), John Muir Cardiovascular Institute, Contra Costa Cardiology — Concord, California, United States

Full record on ClinicalTrials.gov

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