Congestive Heart FailureMIRACLE EFNCT01735916
MIRACLE EF Clinical Study
A study testing CRT-P Implant and CRT-P OFF in people with Congestive Heart Failure and Left Bundle Branch Block, run by Medtronic Cardiac Rhythm and Heart Failure at 73 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure, Left Bundle Branch Block, Systolic Heart Failure
- What is being tested?
- CRT-P Implant and CRT-P OFF
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 73 sitesin 5 countries
- Study dates
- Dec 2012to Mar 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
73 sites in 5 countries.
73 sites in 5 countries
United States69 sites
New Mexico Heart Institute PA
Albuquerque, New Mexico, 87102
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103
Amarillo Heart Group, Northwest Texas Hospital
Amarillo, Texas, 79106
Cardiology Center of Amarillo, Northwest Texas Hospital
Amarillo, Texas, 79106
McFarland Clinic PC
Ames, Iowa, 50010
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Bradenton Cardiology, Manatee Memorial Hospital
Bradenton, Florida, 34205
Buffalo Heart Group LLP, Buffalo Heart Group LLC-Cheektowaga, Mercy Hospital of Buffalo
Buffalo, New York, 14215
Lahey Hospital & Medical Center
Burlington, Massachusetts, 01805
Fletcher Allen Medical Center
Burlington, Vermont, 05405
University of Virginia (UVA) Medical Center
Charlottesville, Virginia, 22908
Lindner Research Center, The Christ Hospital
Cincinnati, Ohio, 45219
Colorado Health Medical Group, Memorial Hospital Colorado Springs
Colorado Springs, Colorado, 80909
Missouri Cardiovascular Specialists, Boone Hospital Center
Columbia, Missouri, 65201
Ohio State University, Ohio State University Medical Center The Richard M Ross Heart Hospital
Columbus, Ohio, 43210
John Muir Medical Center, Cor Cardiovascular Specialists, John Muir Medical Center (Concord), John Muir Cardiovascular Institute, Contra Costa Cardiology
Concord, California, 94520
Samaritan Health Services
Corvallis, Oregon, 97330
HeartPlace Cardiology Research, Baylor Heart & Vascular Hospital
Dallas, Texas, 75226
Cardiovascular Medicine PC (Davenport IA), Trinity (Rock Island), Midwest Cardiovascular Research Foundation, Trinity Bettendorf Hospital
Davenport, Iowa, 52803
Duke University Medical Center (DUMC)
Durham, North Carolina, 27705
Durham VA Medical Center, Duke University Medical Center
Durham, North Carolina, 27710
Advocate Medical Group, Midwest Heart Specialists (Elmhurst), Elmhurst Memorial Hospital
Elmhurst, Illinois, 60126
Mercy Hospital Fairfield, Mercy Hospital Anderson, The Jewish Hospital
Fairfield, Ohio, 45014
Sanford Medical Center
Fargo, North Dakota, 58102
Pee Dee Cardiology, McLeod Regional Medical Center
Florence, South Carolina, 29506
Arrhythmia Consultants (Greenville SC), Greenville Memorial Hospital
Greenville, South Carolina, 29605
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Hartford Hospital
Hartford, Connecticut, 06106
Methodist DeBakey Cardiology Associates, The Methodist Hospital
Houston, Texas, 77030
Glacier View Research Institute Cardiology, Duplicate Glacier View Research Institute Hospital
Kalispell, Montana, 59901
Cardiovascular Consultants, P.C., Saint Luke's Hospital, Mid America Heart Institute (MAHI)
Kansas City, Missouri, 64111
Wellmont CVA Heart Institute, Wellmont Holston Valley Medical Center
Kingsport, Tennessee, 37660
Scripps Clinic Torrey Pines, Scripps Green Hospital
La Jolla, California, 92037
Sparrow Clinical Research Institute, McLaren Hospital
Lansing, Michigan, 48910
VA Greater Los Angeles Healthcare System
Los Angeles, California, 90073
Centra Medical Group Stroobants Cardiovascular Center, Centra Lynchburg General Hospital
Lynchburg, Virginia, 24501
HealthEast HeartCare Clinic at Saint John's
Maplewood, Minnesota, 55109
WellStar Cobb Hospital, WellStar Kennestone Hospital
Marietta, Georgia, 30060
Richmond Cardiology Associates, Bon Secours Memorial Regional Medical Center
Mechanicsville, Virginia, 23116
Melbourne Internal Medicine Associates / Century Research Associates, Holmes Regional Medical Center Hospital
Melbourne, Florida, 32901
Aventura Hospital and Medical Center, Hospital Corporation of America (Aventura), Hospital Corporation of America (Miami)
Miami, Florida, 33137
Aurora Cardiovascular Services, Aurora Sinai Medical Center, Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
The Cardiovascular Center, University of Minnesota Medical Center Fairview
Minneapolis, Minnesota, 55455
Centennial Heart Cardiovascular Consultants LLC
Nashville, Tennessee, 37203
Saint Thomas Research Institute LLC, Baptist Hospital
Nashville, Tennessee, 37205
Mercer Bucks Cardiology, Saint Mary Medical Center, Arrhythmia Institute Hospital
Newtown, Pennsylvania, 18940
Sentara Cardiovascular Specialist, Sentara Williamsburg Regional Medical Center, Sentara Norfolk General Hospital, Sentara Virginia Beach General Hospital
Norfolk, Virginia, 23507
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453
Integris Baptist Medical Center
Oklahoma City, Oklahoma, 73112
Midwest Cardiology Associates PA, Menorah Medical Center, Centerpoint Medical Center, Overland Park Regional Medical Center Hospital
Overland Park, Kansas, 66209
FirstHealth Cardiology Services, FirstHealth Moore Regional Hospital
Pinehurst, North Carolina, 28374
University of Pittsburgh Medical Center UPMC Presbyterian
Pittsburgh, Pennsylvania, 15213
Baylor Research Institute (Plano TX), Legacy Heart Center
Plano, Texas, 75204
Oregon Health & Science University
Portland, Oregon, 97239
Eisenhower Desert Cardiology Center, Eisenhower Medical Center Hospital
Rancho Mirage, California, 92270
North Memorial Heart and Vascular Institute, North Memorial Medical Center
Robbinsdale, Minnesota, 55422
William Beaumont Hospital
Royal Oak, Michigan, 48073
CentraCare Heart & Vascular Center
Saint Cloud, Minnesota, 56303
Minneapolis Heart Institute Foundation, Mercy Hospital (Coon Rapids MN), Unity Hospital, United Hospital, Abbott Northwestern Hospital
Saint Paul, Minnesota, 55102
Harborview Medical Center, University of Washington (UW) Medical Center
Seattle, Washington, 98195
Cardiology Consultants PA, Spartanburg Regional Hospital
Spartanburg, South Carolina, 29303
Prairie Education and Research Cooperative (Springfield IL), Prairie Education Research Consultants, St. John's Hospital (Springfield IL)
Springfield, Illinois, 62701
Mercy Heart and Vascular Clinic, Mercy Hospital St. Louis
St Louis, Missouri, 63141
Stony Brook Islandia Clinic, Stony Brook Hauppauge, Stony Brook University Medical Center
Stony Brook, New York, 11794
Scott & White Hospital
Temple, Texas, 76508
Los Robles Medical Center
Thousand Oaks, California, 91360
Forsyth Medical Center, Novant Clinical Research Institute
Winston-Salem, North Carolina, 27103
Cardiac Diagnostic Associates, York Hospital
York, Pennsylvania, 17405
United Kingdom1 site
University Hospitals of Birmingham NHS Foundation Trust - Queen Elizabeth Hospital
Birmingham, B15 2TH
About this study
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.
Read the 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.
- Being tested
- CRT-P Implant, CRT-P OFF
- Medical subject headings
- Heart Failure, Bundle-Branch Block, Heart Failure, Systolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRT-P ImplantDevice
Also called Cardiac Resynchronization Therapy Pacemaker (CRT-P), Consulta CRT-P, C4TR01
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 OFFDevice
Device programmed to minimal pacing at 40 beats/minute. Device and arrhythmia diagnostics may remain enabled.
| Study group | Role | What they receive |
|---|---|---|
| CRT-P ON | Active comparator | CRT-P Implant CRT-P ON Receives: Device: CRT-P Implant |
| CRT-P OFF | Placebo comparator | CRT-P Implant CRT-P OFF Receives: Device: CRT-P Implant; Device: CRT-P OFF |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: From the date of implant to the date of 6 month follow-up visit
Secondary outcomes (5)
Mortality
Time to death between the study groups
Note: No endpoints were reached, so this objective was not analyzed
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: Assessed from baseline visit to 24-month follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2012 (estimated)
- Study startDec 2012
- Primary completionMar 2014
- Study completionMar 2014
Why it stopped: The study was terminated early due to low enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cecilia Linde, MD PhD, Study chair, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01735916
- Sponsor's protocol ID
- MIRACLE EF
- Acronym
- MIRACLE EF
- Status last verified
- Oct 2017
- First submitted
- 15 Nov 2012
- Last updated
- 6 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MIRACLE EF Clinical Study
- ClinicalTrials.gov ID
- NCT01735916
- Acronym / sponsor ID
- MIRACLE EF / MIRACLE EF
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated early due to low enrollment.
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 28 Nov 2012 (estimated)
- Results
- Posted 6 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRT-P ON | Active comparator | Device: CRT-P ImplantCRT-P Implant CRT-P ON |
| CRT-P OFF | Placebo comparator | Device: CRT-P Implant, Device: CRT-P OFFCRT-P Implant CRT-P OFF |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CRT-P ImplantAlso: Cardiac Resynchronization Therapy Pacemaker (CRT-P), Consulta CRT-P, C4TR01The 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 | CRT-P OFF, CRT-P ON |
| CRT-P OFFDevice programmed to minimal pacing at 40 beats/minute. Device and arrhythmia diagnostics may remain enabled. | Device | CRT-P OFF |
Primary outcome
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
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
System-related Complication
Time frame: From the date of implant to the date of 6 month follow-up visit
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
5 secondary outcomes
Mortality
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
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
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)
Time frame: Assessed from baseline visit to 24-month follow-up visit
Reverse Remodeling by Echocardiography
Time frame: Assessed from baseline visit to 24-month follow-up visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cecilia Linde, MD PhD study chair
Karolinska University Hospital
73 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CRT-P Implant and CRT-P OFF in people with Congestive Heart Failure and Left Bundle Branch Block, run by Medtronic Cardiac Rhythm and Heart Failure at 73 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 73 sites in United States, India, Russia, Sweden, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017.