MIRACLE EF Clinical Study

NCT01735916 | Terminated Results DMC

• 1 other identifier: MIRACLE EF
• Study Type: interventional
• Target: 44
• Locations: 5 countries
• Sites: 73

Brief Summary

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.

Conditions

Congestive Heart Failure; Left Bundle Branch Block; Systolic Heart Failure

Outcome Measures

Primary Outcomes (2)

• 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

  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

  From the date of implant to the date of 6 month follow-up visit

Secondary Outcomes (5)

• Mortality

  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

  From date of randomization to date of event, assessed for a minimum of 24 months and up to 60 months

• Recurrent HF Events

  From date of randomization to date of event, assessed for a minimum of 24 months and up to 60 months

• Quality of Life (QoL)

  Assessed from baseline visit to 24-month follow-up visit

• Reverse Remodeling by Echocardiography

  Assessed from baseline visit to 24-month follow-up visit

Study Arms (2)

CRT-P ON

ACTIVE COMPARATOR

CRT-P Implant CRT-P ON

Device: CRT-P Implant

CRT-P OFF

PLACEBO COMPARATOR

CRT-P Implant CRT-P OFF

Device: CRT-P Implant; Device: CRT-P OFF

Interventions

CRT-P Implant DEVICE

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.

Also known as: Cardiac Resynchronization Therapy Pacemaker (CRT-P), Consulta CRT-P, C4TR01

CRT-P OFF; CRT-P ON

CRT-P OFF DEVICE

Device programmed to minimal pacing at 40 beats/minute. Device and arrhythmia diagnostics may remain enabled.

CRT-P OFF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (73)

John Muir Medical Center, Cor Cardiovascular Specialists, John Muir Medical Center (Concord), John Muir Cardiovascular Institute, Contra Costa Cardiology

Concord, California, 94520, United States

Location

Scripps Clinic Torrey Pines, Scripps Green Hospital

La Jolla, California, 92037, United States

Location

VA Greater Los Angeles Healthcare System

Los Angeles, California, 90073, United States

Location

Eisenhower Desert Cardiology Center, Eisenhower Medical Center Hospital

Rancho Mirage, California, 92270, United States

Location

Los Robles Medical Center

Thousand Oaks, California, 91360, United States

Location

Colorado Health Medical Group, Memorial Hospital Colorado Springs

Colorado Springs, Colorado, 80909, United States

Location

Hartford Hospital

Hartford, Connecticut, 06106, United States

Location

Bradenton Cardiology, Manatee Memorial Hospital

Bradenton, Florida, 34205, United States

Location

Melbourne Internal Medicine Associates / Century Research Associates, Holmes Regional Medical Center Hospital

Melbourne, Florida, 32901, United States

Location

Aventura Hospital and Medical Center, Hospital Corporation of America (Aventura), Hospital Corporation of America (Miami)

Miami, Florida, 33137, United States

Location

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

WellStar Cobb Hospital, WellStar Kennestone Hospital

Marietta, Georgia, 30060, United States

Location

Advocate Medical Group, Midwest Heart Specialists (Elmhurst), Elmhurst Memorial Hospital

Elmhurst, Illinois, 60126, United States

Location

Advocate Christ Medical Center

Oak Lawn, Illinois, 60453, United States

Location

Prairie Education and Research Cooperative (Springfield IL), Prairie Education Research Consultants, St. John's Hospital (Springfield IL)

Springfield, Illinois, 62701, United States

Location

McFarland Clinic PC

Ames, Iowa, 50010, United States

Location

Cardiovascular Medicine PC (Davenport IA), Trinity (Rock Island), Midwest Cardiovascular Research Foundation, Trinity Bettendorf Hospital

Davenport, Iowa, 52803, United States

Location

Midwest Cardiology Associates PA, Menorah Medical Center, Centerpoint Medical Center, Overland Park Regional Medical Center Hospital

Overland Park, Kansas, 66209, United States

Location

Lahey Hospital & Medical Center

Burlington, Massachusetts, 01805, United States

Location

Sparrow Clinical Research Institute, McLaren Hospital

Lansing, Michigan, 48910, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

HealthEast HeartCare Clinic at Saint John's

Maplewood, Minnesota, 55109, United States

Location

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407, United States

Location

The Cardiovascular Center, University of Minnesota Medical Center Fairview

Minneapolis, Minnesota, 55455, United States

Location

North Memorial Heart and Vascular Institute, North Memorial Medical Center

Robbinsdale, Minnesota, 55422, United States

Location

CentraCare Heart & Vascular Center

Saint Cloud, Minnesota, 56303, United States

Location

Minneapolis Heart Institute Foundation, Mercy Hospital (Coon Rapids MN), Unity Hospital, United Hospital, Abbott Northwestern Hospital

Saint Paul, Minnesota, 55102, United States

Location

Missouri Cardiovascular Specialists, Boone Hospital Center

Columbia, Missouri, 65201, United States

Location

Cardiovascular Consultants, P.C., Saint Luke's Hospital, Mid America Heart Institute (MAHI)

Kansas City, Missouri, 64111, United States

Location

Mercy Heart and Vascular Clinic, Mercy Hospital St. Louis

St Louis, Missouri, 63141, United States

Location

Glacier View Research Institute Cardiology, Duplicate Glacier View Research Institute Hospital

Kalispell, Montana, 59901, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

New Mexico Heart Institute PA

Albuquerque, New Mexico, 87102, United States

Location

Buffalo Heart Group LLP, Buffalo Heart Group LLC-Cheektowaga, Mercy Hospital of Buffalo

Buffalo, New York, 14215, United States

Location

Stony Brook Islandia Clinic, Stony Brook Hauppauge, Stony Brook University Medical Center

Stony Brook, New York, 11794, United States

Location

Duke University Medical Center (DUMC)

Durham, North Carolina, 27705, United States

Location

Durham VA Medical Center, Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

FirstHealth Cardiology Services, FirstHealth Moore Regional Hospital

Pinehurst, North Carolina, 28374, United States

Location

Forsyth Medical Center, Novant Clinical Research Institute

Winston-Salem, North Carolina, 27103, United States

Location

Sanford Medical Center

Fargo, North Dakota, 58102, United States

Location

Lindner Research Center, The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

Ohio State University, Ohio State University Medical Center The Richard M Ross Heart Hospital

Columbus, Ohio, 43210, United States

Location

Mercy Hospital Fairfield, Mercy Hospital Anderson, The Jewish Hospital

Fairfield, Ohio, 45014, United States

Location

Integris Baptist Medical Center

Oklahoma City, Oklahoma, 73112, United States

Location

Samaritan Health Services

Corvallis, Oregon, 97330, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Lehigh Valley Hospital

Allentown, Pennsylvania, 18103, United States

Location

Mercer Bucks Cardiology, Saint Mary Medical Center, Arrhythmia Institute Hospital

Newtown, Pennsylvania, 18940, United States

Location

University of Pittsburgh Medical Center UPMC Presbyterian

Pittsburgh, Pennsylvania, 15213, United States

Location

Cardiac Diagnostic Associates, York Hospital

York, Pennsylvania, 17405, United States

Location

Pee Dee Cardiology, McLeod Regional Medical Center

Florence, South Carolina, 29506, United States

Location

Arrhythmia Consultants (Greenville SC), Greenville Memorial Hospital

Greenville, South Carolina, 29605, United States

Location

Cardiology Consultants PA, Spartanburg Regional Hospital

Spartanburg, South Carolina, 29303, United States

Location

Wellmont CVA Heart Institute, Wellmont Holston Valley Medical Center

Kingsport, Tennessee, 37660, United States

Location

Centennial Heart Cardiovascular Consultants LLC

Nashville, Tennessee, 37203, United States

Location

Saint Thomas Research Institute LLC, Baptist Hospital

Nashville, Tennessee, 37205, United States

Location

Amarillo Heart Group, Northwest Texas Hospital

Amarillo, Texas, 79106, United States

Location

Cardiology Center of Amarillo, Northwest Texas Hospital

Amarillo, Texas, 79106, United States

Location

HeartPlace Cardiology Research, Baylor Heart & Vascular Hospital

Dallas, Texas, 75226, United States

Location

Methodist DeBakey Cardiology Associates, The Methodist Hospital

Houston, Texas, 77030, United States

Location

Baylor Research Institute (Plano TX), Legacy Heart Center

Plano, Texas, 75204, United States

Location

Scott & White Hospital

Temple, Texas, 76508, United States

Location

Fletcher Allen Medical Center

Burlington, Vermont, 05405, United States

Location

University of Virginia (UVA) Medical Center

Charlottesville, Virginia, 22908, United States

Location

Centra Medical Group Stroobants Cardiovascular Center, Centra Lynchburg General Hospital

Lynchburg, Virginia, 24501, United States

Location

Richmond Cardiology Associates, Bon Secours Memorial Regional Medical Center

Mechanicsville, Virginia, 23116, United States

Location

Sentara Cardiovascular Specialist, Sentara Williamsburg Regional Medical Center, Sentara Norfolk General Hospital, Sentara Virginia Beach General Hospital

Norfolk, Virginia, 23507, United States

Location

Harborview Medical Center, University of Washington (UW) Medical Center

Seattle, Washington, 98195, United States

Location

Aurora Cardiovascular Services, Aurora Sinai Medical Center, Aurora Saint Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

Medanta-The Medicity

Haryāna, 122041, India

Location

Tyumen Cardiology Center

Tyumen, 625026, Russia

Location

Karolinska University Hospital

Stockholm, 17176, Sweden

Location

University Hospitals of Birmingham NHS Foundation Trust - Queen Elizabeth Hospital

Birmingham, B15 2TH, United Kingdom

Location

MeSH Terms

Conditions

Heart Failure; Bundle-Branch Block; Heart Failure, Systolic

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Heart Block; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: MIRACLE EF Study Manager
• Organization: Medtronic

medtroniccrmtrials@medtronic.com

(763) 514-4000

Study Officials

• Cecilia Linde, MD PhD

  Karolinska University Hospital

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2012
• First Posted: November 28, 2012
• Study Start: December 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: November 6, 2017
• Results First Posted: October 6, 2014

Record last verified: 2017-10

Locations

US (69); IN (1); SE (1); GB (1); RU (1)