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MIRACLE EF Clinical Study

This study is currently recruiting participants.
Verified January 2013 by Medtronic Cardiac Rhythm Disease Management
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT01735916
First received: November 15, 2012
Last updated: January 28, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
Congestive Heart Failure
Left Bundle Branch Block
Systolic Heart Failure
 Device: CRT-P Implant
Device: CRT-P OFF

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: MIRACLE EF Clinical Study

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Primary Outcome Measures:
  • Time to mortality or heart failure morbidity [ Time Frame: From date of randomization to date of event, assessed for a minimum of 24 months and up to 60 months ] [ Designated as safety issue: No ]

    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

  • Time to system-related complication [ Time Frame: From the date of implant to the date of 6 month follow-up visit ] [ Designated as safety issue: Yes ]
    Primary Safety Endpoint: Time to first system-related complication in subjects with a successful implant


Secondary Outcome Measures:
  • Mortality [ Time Frame: From date of randomization to date of death, for a minimum of 24 months and up to 60 months ] [ Designated as safety issue: No ]
    Time to death between the study groups

  • Time to mortality or heart failure morbidity or worsening systolic function [ Time Frame: From date of randomization to date of event, assessed for a minimum of 24 months and up to 60 months ] [ Designated as safety issue: No ]

    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

  • Recurrent HF Events [ Time Frame: From date of randomization to date of event, assessed for a minimum of 24 months and up to 60 months ] [ Designated as safety issue: No ]
    The frequency of HF events between the study groups

  • Quality of Life (QoL) [ Time Frame: Assessed from baseline visit to 24-month follow-up visit ] [ Designated as safety issue: No ]
    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.

  • Reverse Remodeling by Echocardiography [ Time Frame: Assessed from baseline visit to 24-month follow-up visit ] [ Designated as safety issue: No ]
    The change in LVEF between study groups.


Estimated Enrollment: 2900
Study Start Date: December 2012
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CRT-P ON
CRT-P Implant CRT-P ON
 Device: 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.

Other Names:
  • Cardiac Resynchronization Therapy Pacemaker (CRT-P)
  • Consulta CRT-P
  • C4TR01
Placebo Comparator: CRT-P OFF
CRT-P Implant CRT-P OFF
 Device: 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.

Other Names:
  • Cardiac Resynchronization Therapy Pacemaker (CRT-P)
  • Consulta CRT-P
  • C4TR01
Device: CRT-P OFF
Device programmed to minimal pacing at 40 beats/minute. Device and arrhythmia diagnostics may remain enabled.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01735916

Contacts
Contact: MIRACLE EF Study Manager medtroniccrmtrials@medtronic.com

Locations
United States, Ohio
The Christ Hospital, Lindner Research Center Recruiting
Cincinnati, Ohio, United States, 45219
Principal Investigator: Greg Egnaczyk, MD, PhD, FACC            
Sponsors and Collaborators
Medtronic Cardiac Rhythm Disease Management
Investigators
Study Chair: Cecilia Linde, MD PhD Karolinska Hospital, Stockholm, Sweden
  More Information

No publications provided

Responsible Party: Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier: NCT01735916     History of Changes
Other Study ID Numbers: MIRACLE EF
Study First Received: November 15, 2012
Last Updated: January 28, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Bundle-Branch Block
Heart Block
Heart Failure
Heart Failure, Systolic
 Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on June 13, 2013