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.
Medtronic, Inc. is sponsoring the MIRACLE EF study, a prospective, randomized, controlled, double-blinded, global multi-center, Cardiac Resynchronization Therapy (CRT) in Heart Failure (HF) clinical study. The purpose of this study is to evaluate market released CRT pacemaker (CRT-P) devices in symptomatic HF patients with less severe left ventricular systolic dysfunction, specifically patients with reduced left ventricular ejection fraction (LVEF) in the range of 36% to 50%. This study will support expansion of indications for CRT worldwide. The outcome of this study is expected to support modification of existing U.S. and Japanese labeling for Medtronic's implantable CRT-P devices and to provide further evidence to support changes to cardiology practice guidelines (ACC/AHA, ESC guidelines) regarding the use of CRT in patients with mild to moderate HF. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
44
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.
Device programmed to minimal pacing at 40 beats/minute. Device and arrhythmia diagnostics may remain enabled.
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
Mortality or Heart Failure Morbidity
Primary Efficacy Endpoint: The time to first event, with event defined as: * All-cause mortality, or * HF Event, defined as either: * Inpatient hospitalization for HF, or * Outpatient event requiring invasive clinical intervention and management for HF (i.e. IV diuretics, ultrafiltration, or equivalent) and overnight stay Note: No endpoints were reached, so this objective was not analyzed
Time frame: From date of randomization to date of event, assessed for a minimum of 24 months and up to 60 months
System-related Complication
Primary Safety Endpoint: Time to first system-related complication in subjects with a successful implant. Note: Because of the small number of subjects, number of complications was noted between arms and a time to event analysis was not performed. Complication is defined as: An adverse event that results in death, involves any termination of significant device function, or requires an invasive intervention
Time frame: From the date of implant to the date of 6 month follow-up visit
Mortality
Time to death between the study groups Note: No endpoints were reached, so this objective was not analyzed
Time frame: From date of randomization to date of death, for a minimum of 24 months and up to 60 months
Mortality or Heart Failure Morbidity or Worsening Systolic Function
Secondary Composite Efficacy Endpoint: The time to first event, with event defined as: * All-cause mortality * HF Event, defined as either: * Inpatient hospitalization for HF, or * Outpatient event requiring invasive clinical intervention and management for HF (i.e. IV diuretics, ultrafiltration, or equivalent) and overnight stay, or * Worsening systolic function meeting an ICD/CRT-D indication, defined as: * A drop in LVEF to 35% or below, with an absolute decrease of greater than or equal to 10%, after maximum tolerated doses of guideline HF medications have been established Note: No endpoints were reached, so this objective was not analyzed
Time frame: From date of randomization to date of event, assessed for a minimum of 24 months and up to 60 months
Recurrent HF Events
The frequency of HF events between the study groups Note: No endpoints were reached, so this objective was not analyzed \- HF Event, defined as either: * Inpatient hospitalization for HF, or * Outpatient event requiring invasive clinical intervention and management for HF (i.e. IV diuretics, ultrafiltration, or equivalent) and overnight stay
Time frame: From date of randomization to date of event, assessed for a minimum of 24 months and up to 60 months
Quality of Life (QoL)
The quality of life between study groups and the change in quality of life over time between study groups using clinically accepted quality of life measures. Note: No subjects completed 24 months of follow-up, so this objective could not be analyzed. Two QOL questionnaires were used in the study. EQ-5D: scores typically range from 0-1, where higher scores reflect better quality of life KCCQ: scores range from 0-100, where higher scores reflect better quality of life
Time frame: Assessed from baseline visit to 24-month follow-up visit
Reverse Remodeling by Echocardiography
The change in LVEF between study groups. Note: No subjects completed 24 months of follow-up, so this objective could not be analyzed.
Time frame: Assessed from baseline visit to 24-month follow-up visit
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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
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