MIRACLE EF Clinical Study

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01735916
• Collaborator: (none)
• Enrollment: 44
• Locations: 73
• Arms: 2
• Duration (Months): 14.9
• Patients Per Site: 0.6
• Patients Per Site Per Month: 0

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Congestive Heart Failure; Left Bundle Branch Block; Systolic Heart Failure	Device: CRT-P Implant; Device: CRT-P OFF	N/A

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

• Study Type: Interventional
• Actual Enrollment: 44 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: MIRACLE EF Clinical Study
• Study Start Date: Dec 1, 2012
• Actual Primary Completion Date: Mar 1, 2014
• Actual Study Completion Date: Mar 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Mortality or Heart Failure Morbidity [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

2. System-related Complication [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

Secondary Outcome Measures

1. Mortality [From date of randomization to date of death, for a minimum of 24 months and up to 60 months]

   Time to death between the study groups Note: No endpoints were reached, so this objective was not analyzed

2. 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]

   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

3. Recurrent HF Events [From date of randomization to date of event, assessed for a minimum of 24 months and up to 60 months]

   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

4. Quality of Life (QoL) [Assessed from baseline visit to 24-month follow-up visit]

   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

5. Reverse Remodeling by Echocardiography [Assessed from baseline visit to 24-month follow-up visit]

   The change in LVEF between study groups. Note: No subjects completed 24 months of follow-up, so this objective could not be analyzed.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	John Muir Medical Center, Cor Cardiovascular Specialists, John Muir Medical Center (Concord), John Muir Cardiovascular Institute, Contra Costa Cardiology	Concord	California	United States	94520
2	Scripps Clinic Torrey Pines, Scripps Green Hospital	La Jolla	California	United States	92037
3	VA Greater Los Angeles Healthcare System	Los Angeles	California	United States	90073
4	Eisenhower Desert Cardiology Center, Eisenhower Medical Center Hospital	Rancho Mirage	California	United States	92270
5	Los Robles Medical Center	Thousand Oaks	California	United States	91360
6	Colorado Health Medical Group, Memorial Hospital Colorado Springs	Colorado Springs	Colorado	United States	80909
7	Hartford Hospital	Hartford	Connecticut	United States	06106
8	Bradenton Cardiology, Manatee Memorial Hospital	Bradenton	Florida	United States	34205
9	Melbourne Internal Medicine Associates / Century Research Associates, Holmes Regional Medical Center Hospital	Melbourne	Florida	United States	32901
10	Aventura Hospital and Medical Center, Hospital Corporation of America (Aventura), Hospital Corporation of America (Miami)	Miami	Florida	United States	33137
11	Emory University Hospital Midtown	Atlanta	Georgia	United States	30308
12	WellStar Cobb Hospital, WellStar Kennestone Hospital	Marietta	Georgia	United States	30060
13	Advocate Medical Group, Midwest Heart Specialists (Elmhurst), Elmhurst Memorial Hospital	Elmhurst	Illinois	United States	60126
14	Advocate Christ Medical Center	Oak Lawn	Illinois	United States	60453
15	Prairie Education and Research Cooperative (Springfield IL), Prairie Education Research Consultants, St. John's Hospital (Springfield IL)	Springfield	Illinois	United States	62701
16	McFarland Clinic PC	Ames	Iowa	United States	50010
17	Cardiovascular Medicine PC (Davenport IA), Trinity (Rock Island), Midwest Cardiovascular Research Foundation, Trinity Bettendorf Hospital	Davenport	Iowa	United States	52803
18	Midwest Cardiology Associates PA, Menorah Medical Center, Centerpoint Medical Center, Overland Park Regional Medical Center Hospital	Overland Park	Kansas	United States	66209
19	Lahey Hospital & Medical Center	Burlington	Massachusetts	United States	01805
20	Sparrow Clinical Research Institute, McLaren Hospital	Lansing	Michigan	United States	48910
21	William Beaumont Hospital	Royal Oak	Michigan	United States	48073
22	HealthEast HeartCare Clinic at Saint John's	Maplewood	Minnesota	United States	55109
23	Minneapolis Heart Institute Foundation	Minneapolis	Minnesota	United States	55407
24	The Cardiovascular Center, University of Minnesota Medical Center Fairview	Minneapolis	Minnesota	United States	55455
25	North Memorial Heart and Vascular Institute, North Memorial Medical Center	Robbinsdale	Minnesota	United States	55422
26	CentraCare Heart & Vascular Center	Saint Cloud	Minnesota	United States	56303
27	Minneapolis Heart Institute Foundation, Mercy Hospital (Coon Rapids MN), Unity Hospital, United Hospital, Abbott Northwestern Hospital	Saint Paul	Minnesota	United States	55102
28	Missouri Cardiovascular Specialists, Boone Hospital Center	Columbia	Missouri	United States	65201
29	Cardiovascular Consultants, P.C., Saint Luke's Hospital, Mid America Heart Institute (MAHI)	Kansas City	Missouri	United States	64111
30	Mercy Heart and Vascular Clinic, Mercy Hospital St. Louis	Saint Louis	Missouri	United States	63141
31	Glacier View Research Institute Cardiology, Duplicate Glacier View Research Institute Hospital	Kalispell	Montana	United States	59901
32	Hackensack University Medical Center	Hackensack	New Jersey	United States	07601
33	New Mexico Heart Institute PA	Albuquerque	New Mexico	United States	87102
34	Buffalo Heart Group LLP, Buffalo Heart Group LLC-Cheektowaga, Mercy Hospital of Buffalo	Buffalo	New York	United States	14215
35	Stony Brook Islandia Clinic, Stony Brook Hauppauge, Stony Brook University Medical Center	Stony Brook	New York	United States	11794
36	Duke University Medical Center (DUMC)	Durham	North Carolina	United States	27705
37	Durham VA Medical Center, Duke University Medical Center	Durham	North Carolina	United States	27710
38	FirstHealth Cardiology Services, FirstHealth Moore Regional Hospital	Pinehurst	North Carolina	United States	28374
39	Forsyth Medical Center, Novant Clinical Research Institute	Winston-Salem	North Carolina	United States	27103
40	Sanford Medical Center	Fargo	North Dakota	United States	58102
41	Lindner Research Center, The Christ Hospital	Cincinnati	Ohio	United States	45219
42	Ohio State University, Ohio State University Medical Center The Richard M Ross Heart Hospital	Columbus	Ohio	United States	43210
43	Mercy Hospital Fairfield, Mercy Hospital Anderson, The Jewish Hospital	Fairfield	Ohio	United States	45014
44	Integris Baptist Medical Center	Oklahoma City	Oklahoma	United States	73112
45	Samaritan Health Services	Corvallis	Oregon	United States	97330
46	Oregon Health & Science University	Portland	Oregon	United States	97239
47	Lehigh Valley Hospital	Allentown	Pennsylvania	United States	18103
48	Mercer Bucks Cardiology, Saint Mary Medical Center, Arrhythmia Institute Hospital	Newtown	Pennsylvania	United States	18940
49	University of Pittsburgh Medical Center UPMC Presbyterian	Pittsburgh	Pennsylvania	United States	15213
50	Cardiac Diagnostic Associates, York Hospital	York	Pennsylvania	United States	17405
51	Pee Dee Cardiology, McLeod Regional Medical Center	Florence	South Carolina	United States	29506
52	Arrhythmia Consultants (Greenville SC), Greenville Memorial Hospital	Greenville	South Carolina	United States	29605
53	Cardiology Consultants PA, Spartanburg Regional Hospital	Spartanburg	South Carolina	United States	29303
54	Wellmont CVA Heart Institute, Wellmont Holston Valley Medical Center	Kingsport	Tennessee	United States	37660
55	Centennial Heart Cardiovascular Consultants LLC	Nashville	Tennessee	United States	37203
56	Saint Thomas Research Institute LLC, Baptist Hospital	Nashville	Tennessee	United States	37205
57	Amarillo Heart Group, Northwest Texas Hospital	Amarillo	Texas	United States	79106
58	Cardiology Center of Amarillo, Northwest Texas Hospital	Amarillo	Texas	United States	79106
59	HeartPlace Cardiology Research, Baylor Heart & Vascular Hospital	Dallas	Texas	United States	75226
60	Methodist DeBakey Cardiology Associates, The Methodist Hospital	Houston	Texas	United States	77030
61	Baylor Research Institute (Plano TX), Legacy Heart Center	Plano	Texas	United States	75204
62	Scott & White Hospital	Temple	Texas	United States	76508
63	Fletcher Allen Medical Center	Burlington	Vermont	United States	05405
64	University of Virginia (UVA) Medical Center	Charlottesville	Virginia	United States	22908
65	Centra Medical Group Stroobants Cardiovascular Center, Centra Lynchburg General Hospital	Lynchburg	Virginia	United States	24501
66	Richmond Cardiology Associates, Bon Secours Memorial Regional Medical Center	Mechanicsville	Virginia	United States	23116
67	Sentara Cardiovascular Specialist, Sentara Williamsburg Regional Medical Center, Sentara Norfolk General Hospital, Sentara Virginia Beach General Hospital	Norfolk	Virginia	United States	23507
68	Harborview Medical Center, University of Washington (UW) Medical Center	Seattle	Washington	United States	98195
69	Aurora Cardiovascular Services, Aurora Sinai Medical Center, Aurora Saint Luke's Medical Center	Milwaukee	Wisconsin	United States	53215
70	Medanta-The Medicity	Haryana		India	122041
71	Tyumen Cardiology Center	Tyumen		Russian Federation	625026
72	Karolinska University Hospital	Stockholm		Sweden	17176
73	University Hospitals of Birmingham NHS Foundation Trust - Queen Elizabeth Hospital	Birmingham		United Kingdom	B15 2TH

Sponsors and Collaborators

• Medtronic Cardiac Rhythm and Heart Failure

Investigators

• Study Chair: Cecilia Linde, MD PhD, Karolinska University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
• ClinicalTrials.gov Identifier: NCT01735916
• Other Study ID Numbers: MIRACLE EF
• First Posted: Nov 28, 2012
• Last Update Posted: Nov 6, 2017
• Last Verified: Oct 1, 2017

• Additional relevant MeSH terms: Heart Failure; Heart Failure, Systolic; Bundle-Branch Block

Study Results

Participant Flow

Arm/Group Title	No Implant Attempt	CRT-P ON	CRT-P OFF
Arm/Group Description	Subjects who did not undergo an implant attempt of a CRT-P device and were not randomized.	Subjects who were implanted with a CRT-P device and device programmed to provide simultaneous or sequential biventricular pacing to provide patients with cardiac resynchronization therapy. The device also provides diagnostic and monitoring information that assists with system evaluation and patient care.	Subjects who were implanted with a CRT-P device and device programmed to minimal right ventricular-only pacing at 40 beats/minute. Device and arrhythmia diagnostics may remain enabled.
Period Title: Overall Study
STARTED	18	19	7
COMPLETED	0	0	0
NOT COMPLETED	18	19	7

Baseline Characteristics

Arm/Group Title	No Implant Attempt	CRT-P ON	CRT-P OFF	Total
Arm/Group Description	Subjects who did not undergo an implant attempt of a CRT-P device and were not randomized.	Subjects who were implanted with a CRT-P device and device programmed to provide simultaneous or sequential biventricular pacing to provide patients with cardiac resynchronization therapy. The device also provides diagnostic and monitoring information that assists with system evaluation and patient care.	Subjects who were implanted with a CRT-P device and device programmed to minimal right ventricular-only pacing at 40 beats/minute. Device and arrhythmia diagnostics may remain enabled.	Total of all reporting groups
Overall Participants	18	19	7	44
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	68.5 (10.4)	69.2 (10.3)	69.3 (7.0)	69.0 (9.5)
Sex/Gender, Customized (participants) [Number]
Male	5 27.8%	5 26.3%	6 85.7%	16 36.4%
Female	3 16.7%	14 73.7%	1 14.3%	18 40.9%
Not Reported	10 55.6%	0 0%	0 0%	10 22.7%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	1 5.6%	2 10.5%	0 0%	3 6.8%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%	0 0%
White	6 33.3%	17 89.5%	7 100%	30 68.2%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	11 61.1%	0 0%	0 0%	11 25%
Body Mass Index (BMI) (kilogram/(meter*meter)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kilogram/(meter*meter)]	29.3 (4.9)	31.5 (7.0)	32.5 (3.6)	31.2 (6.0)
Heart rate (intrinsic beats/minute) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [intrinsic beats/minute]	63.4 (12.8)	72.6 (10.3)	64.3 (6.7)	68.7 (11.0)
Systolic blood pressure (mm Hg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mm Hg]	130.9 (20.7)	131.5 (21.4)	121.1 (19.0)	129.2 (20.6)
Diastolic blood pressure (mm Hg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mm Hg]	74.4 (9.4)	74.4 (10.2)	66.6 (11.5)	72.8 (10.5)
New York Heart Association classification (participants) [Number]
NYHA Class II	11 61.1%	2 10.5%	3 42.9%	16 36.4%
NYHA Class III	5 27.8%	17 89.5%	4 57.1%	26 59.1%
Not Reported	2 11.1%	0 0%	0 0%	2 4.5%

Outcome Measures

1. Primary Outcome

Title	Mortality or Heart Failure Morbidity
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CRT-P ON	CRT-P OFF
Arm/Group Description	Subjects who were implanted with a CRT-P device and device programmed to provide simultaneous or sequential biventricular pacing to provide patients with cardiac resynchronization therapy. The device also provides diagnostic and monitoring information that assists with system evaluation and patient care.	Subjects who were implanted with a CRT-P device and device programmed to minimal right ventricular-only pacing at 40 beats/minute. Device and arrhythmia diagnostics may remain enabled.
Measure Participants	0	0

2. Primary Outcome

Title	System-related Complication
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CRT-P ON	CRT-P OFF
Arm/Group Description	Subjects who were implanted with a CRT-P device and device programmed to provide simultaneous or sequential biventricular pacing to provide patients with cardiac resynchronization therapy. The device also provides diagnostic and monitoring information that assists with system evaluation and patient care.	Subjects who were implanted with a CRT-P device and device programmed to minimal right ventricular-only pacing at 40 beats/minute. Device and arrhythmia diagnostics may remain enabled.
Measure Participants	19	7
Number [Complications]	1	2

3. Secondary Outcome

Title	Mortality
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CRT-P ON	CRT-P OFF
Arm/Group Description	Subjects who were implanted with a CRT-P device and device programmed to provide simultaneous or sequential biventricular pacing to provide patients with cardiac resynchronization therapy. The device also provides diagnostic and monitoring information that assists with system evaluation and patient care.	Subjects who were implanted with a CRT-P device and device programmed to minimal right ventricular-only pacing at 40 beats/minute. Device and arrhythmia diagnostics may remain enabled.
Measure Participants	0	0

4. Secondary Outcome

Title	Mortality or Heart Failure Morbidity or Worsening Systolic Function
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CRT-P ON	CRT-P OFF
Arm/Group Description	Subjects who were implanted with a CRT-P device and device programmed to provide simultaneous or sequential biventricular pacing to provide patients with cardiac resynchronization therapy. The device also provides diagnostic and monitoring information that assists with system evaluation and patient care.	Subjects who were implanted with a CRT-P device and device programmed to minimal right ventricular-only pacing at 40 beats/minute. Device and arrhythmia diagnostics may remain enabled.
Measure Participants	0	0

5. Secondary Outcome

Title	Recurrent HF Events
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CRT-P ON	CRT-P OFF
Arm/Group Description	Subjects who were implanted with a CRT-P device and device programmed to provide simultaneous or sequential biventricular pacing to provide patients with cardiac resynchronization therapy. The device also provides diagnostic and monitoring information that assists with system evaluation and patient care.	Subjects who were implanted with a CRT-P device and device programmed to minimal right ventricular-only pacing at 40 beats/minute. Device and arrhythmia diagnostics may remain enabled.
Measure Participants	0	0

6. Secondary Outcome

Title	Quality of Life (QoL)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CRT-P ON	CRT-P OFF
Arm/Group Description	Subjects who were implanted with a CRT-P device and device programmed to provide simultaneous or sequential biventricular pacing to provide patients with cardiac resynchronization therapy. The device also provides diagnostic and monitoring information that assists with system evaluation and patient care.	Subjects who were implanted with a CRT-P device and device programmed to minimal right ventricular-only pacing at 40 beats/minute. Device and arrhythmia diagnostics may remain enabled.
Measure Participants	0	0

7. Secondary Outcome

Title	Reverse Remodeling by Echocardiography
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CRT-P ON	CRT-P OFF
Arm/Group Description	Subjects who were implanted with a CRT-P device and device programmed to provide simultaneous or sequential biventricular pacing to provide patients with cardiac resynchronization therapy. The device also provides diagnostic and monitoring information that assists with system evaluation and patient care.	Subjects who were implanted with a CRT-P device and device programmed to minimal right ventricular-only pacing at 40 beats/minute. Device and arrhythmia diagnostics may remain enabled.
Measure Participants	0	0

Adverse Events

Time Frame	Adverse events were collected from the point of enrollment. Due to the study being halted early, no subject was followed for more than 14 months post-implantation of a CRT device.
Arm/Group Title	No Implant Attempt		CRT-P ON		CRT-P OFF
Arm/Group Description	Subjects who did not undergo an implant attempt of a CRT-P device and were not randomized.		Subjects who were implanted with a CRT-P device and device programmed to provide simultaneous or sequential biventricular pacing to provide patients with cardiac resynchronization therapy. The device also provides diagnostic and monitoring information that assists with system evaluation and patient care.		Subjects who were implanted with a CRT-P device and device programmed to minimal pacing at 40 beats/minute. Device and arrhythmia diagnostics may remain enabled.
All Cause Mortality
	No Implant Attempt		CRT-P ON		CRT-P OFF
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		0/19 (0%)		0/7 (0%)
Serious Adverse Events
	No Implant Attempt		CRT-P ON		CRT-P OFF
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		1/19 (5.3%)		2/7 (28.6%)
Cardiac disorders
Atrial flutter	0/18 (0%)	0	1/19 (5.3%)	1	0/7 (0%)	0
Infections and infestations
Enterocolitis bacterial	0/18 (0%)	0	0/19 (0%)	0	1/7 (14.3%)	1
Sepsis	0/18 (0%)	0	0/19 (0%)	0	1/7 (14.3%)	1
Injury, poisoning and procedural complications
Device dislocation	0/18 (0%)	0	0/19 (0%)	0	1/7 (14.3%)	1
Nervous system disorders
Metabolic encephalopathy	0/18 (0%)	0	0/19 (0%)	0	1/7 (14.3%)	1
Renal and urinary disorders
Renal failure acute	0/18 (0%)	0	0/19 (0%)	0	1/7 (14.3%)	1
Other (Not Including Serious) Adverse Events
	No Implant Attempt		CRT-P ON		CRT-P OFF
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		6/19 (31.6%)		2/7 (28.6%)
Cardiac disorders
Ischaemic cardiomyopathy	0/18 (0%)	0	0/19 (0%)	0	1/7 (14.3%)	1
Cardiac failure	0/18 (0%)	0	1/19 (5.3%)	1	0/7 (0%)	0
Infections and infestations
Wound infection	0/18 (0%)	0	1/19 (5.3%)	1	0/7 (0%)	0
Injury, poisoning and procedural complications
Device dislocation	0/18 (0%)	0	1/19 (5.3%)	1	1/7 (14.3%)	1
Implant site haematoma	0/18 (0%)	0	1/19 (5.3%)	1	0/7 (0%)	0
Vascular disorders
Hypertension	0/18 (0%)	0	1/19 (5.3%)	1	0/7 (0%)	0
Orthostatic hypotension	0/18 (0%)	0	1/19 (5.3%)	1	0/7 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.