Trial Outcomes & Findings for MIRACLE EF Clinical Study (NCT NCT01735916)
NCT ID: NCT01735916
Last Updated: 2017-11-06
Results Overview
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
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
44 participants
Primary outcome timeframe
From date of randomization to date of event, assessed for a minimum of 24 months and up to 60 months
Results posted on
2017-11-06
Participant Flow
Participant milestones
| Measure |
No Implant Attempt
Subjects who did not undergo an implant attempt of a CRT-P device and were not randomized.
|
CRT-P ON
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.
|
CRT-P OFF
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
18
|
19
|
7
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
18
|
19
|
7
|
Reasons for withdrawal
| Measure |
No Implant Attempt
Subjects who did not undergo an implant attempt of a CRT-P device and were not randomized.
|
CRT-P ON
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.
|
CRT-P OFF
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.
|
|---|---|---|---|
|
Overall Study
Subject not eligible to be randomized
|
11
|
0
|
0
|
|
Overall Study
Early termination of study by sponsor
|
4
|
19
|
7
|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
0
|
Baseline Characteristics
MIRACLE EF Clinical Study
Baseline characteristics by cohort
| Measure |
No Implant Attempt
n=18 Participants
Subjects who did not undergo an implant attempt of a CRT-P device and were not randomized.
|
CRT-P ON
n=19 Participants
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.
|
CRT-P OFF
n=7 Participants
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
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
68.5 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
69.2 years
STANDARD_DEVIATION 10.3 • n=7 Participants
|
69.3 years
STANDARD_DEVIATION 7.0 • n=5 Participants
|
69.0 years
STANDARD_DEVIATION 9.5 • n=4 Participants
|
|
Sex/Gender, Customized
Male
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
6 participants
n=5 Participants
|
16 participants
n=4 Participants
|
|
Sex/Gender, Customized
Female
|
3 participants
n=5 Participants
|
14 participants
n=7 Participants
|
1 participants
n=5 Participants
|
18 participants
n=4 Participants
|
|
Sex/Gender, Customized
Not Reported
|
10 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
10 participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Body Mass Index (BMI)
|
29.3 kilogram/(meter*meter)
STANDARD_DEVIATION 4.9 • n=5 Participants
|
31.5 kilogram/(meter*meter)
STANDARD_DEVIATION 7.0 • n=7 Participants
|
32.5 kilogram/(meter*meter)
STANDARD_DEVIATION 3.6 • n=5 Participants
|
31.2 kilogram/(meter*meter)
STANDARD_DEVIATION 6.0 • n=4 Participants
|
|
Heart rate
|
63.4 intrinsic beats/minute
STANDARD_DEVIATION 12.8 • n=5 Participants
|
72.6 intrinsic beats/minute
STANDARD_DEVIATION 10.3 • n=7 Participants
|
64.3 intrinsic beats/minute
STANDARD_DEVIATION 6.7 • n=5 Participants
|
68.7 intrinsic beats/minute
STANDARD_DEVIATION 11.0 • n=4 Participants
|
|
Systolic blood pressure
|
130.9 mm Hg
STANDARD_DEVIATION 20.7 • n=5 Participants
|
131.5 mm Hg
STANDARD_DEVIATION 21.4 • n=7 Participants
|
121.1 mm Hg
STANDARD_DEVIATION 19.0 • n=5 Participants
|
129.2 mm Hg
STANDARD_DEVIATION 20.6 • n=4 Participants
|
|
Diastolic blood pressure
|
74.4 mm Hg
STANDARD_DEVIATION 9.4 • n=5 Participants
|
74.4 mm Hg
STANDARD_DEVIATION 10.2 • n=7 Participants
|
66.6 mm Hg
STANDARD_DEVIATION 11.5 • n=5 Participants
|
72.8 mm Hg
STANDARD_DEVIATION 10.5 • n=4 Participants
|
|
New York Heart Association classification
NYHA Class II
|
11 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
16 participants
n=4 Participants
|
|
New York Heart Association classification
NYHA Class III
|
5 participants
n=5 Participants
|
17 participants
n=7 Participants
|
4 participants
n=5 Participants
|
26 participants
n=4 Participants
|
|
New York Heart Association classification
Not Reported
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From date of randomization to date of event, assessed for a minimum of 24 months and up to 60 monthsPrimary 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
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: From the date of implant to the date of 6 month follow-up visitPrimary 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
Outcome measures
| Measure |
CRT-P ON
n=19 Participants
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.
|
CRT-P OFF
n=7 Participants
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.
|
|---|---|---|
|
System-related Complication
|
1 Complications
|
2 Complications
|
SECONDARY outcome
Timeframe: From date of randomization to date of death, for a minimum of 24 months and up to 60 monthsTime to death between the study groups Note: No endpoints were reached, so this objective was not analyzed
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From date of randomization to date of event, assessed for a minimum of 24 months and up to 60 monthsSecondary 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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From date of randomization to date of event, assessed for a minimum of 24 months and up to 60 monthsThe 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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Assessed from baseline visit to 24-month follow-up visitThe 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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Assessed from baseline visit to 24-month follow-up visitThe change in LVEF between study groups. Note: No subjects completed 24 months of follow-up, so this objective could not be analyzed.
Outcome measures
Outcome data not reported
Adverse Events
No Implant Attempt
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CRT-P ON
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
CRT-P OFF
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
No Implant Attempt
n=18 participants at risk
Subjects who did not undergo an implant attempt of a CRT-P device and were not randomized.
|
CRT-P ON
n=19 participants at risk
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.
|
CRT-P OFF
n=7 participants at risk
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.
|
|---|---|---|---|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/18 • 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.
|
5.3%
1/19 • Number of events 1 • 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.
|
0.00%
0/7 • 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.
|
|
Injury, poisoning and procedural complications
Device dislocation
|
0.00%
0/18 • 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.
|
0.00%
0/19 • 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.
|
14.3%
1/7 • Number of events 1 • 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.
|
|
Infections and infestations
Enterocolitis bacterial
|
0.00%
0/18 • 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.
|
0.00%
0/19 • 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.
|
14.3%
1/7 • Number of events 1 • 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.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/18 • 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.
|
0.00%
0/19 • 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.
|
14.3%
1/7 • Number of events 1 • 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.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/18 • 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.
|
0.00%
0/19 • 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.
|
14.3%
1/7 • Number of events 1 • 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.
|
|
Infections and infestations
Sepsis
|
0.00%
0/18 • 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.
|
0.00%
0/19 • 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.
|
14.3%
1/7 • Number of events 1 • 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.
|
Other adverse events
| Measure |
No Implant Attempt
n=18 participants at risk
Subjects who did not undergo an implant attempt of a CRT-P device and were not randomized.
|
CRT-P ON
n=19 participants at risk
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.
|
CRT-P OFF
n=7 participants at risk
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.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Device dislocation
|
0.00%
0/18 • 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.
|
5.3%
1/19 • Number of events 1 • 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.
|
14.3%
1/7 • Number of events 1 • 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.
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.00%
0/18 • 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.
|
0.00%
0/19 • 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.
|
14.3%
1/7 • Number of events 1 • 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.
|
|
Infections and infestations
Wound infection
|
0.00%
0/18 • 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.
|
5.3%
1/19 • Number of events 1 • 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.
|
0.00%
0/7 • 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.
|
|
Vascular disorders
Hypertension
|
0.00%
0/18 • 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.
|
5.3%
1/19 • Number of events 1 • 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.
|
0.00%
0/7 • 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.
|
|
Injury, poisoning and procedural complications
Implant site haematoma
|
0.00%
0/18 • 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.
|
5.3%
1/19 • Number of events 1 • 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.
|
0.00%
0/7 • 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.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/18 • 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.
|
5.3%
1/19 • Number of events 1 • 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.
|
0.00%
0/7 • 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.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/18 • 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.
|
5.3%
1/19 • Number of events 1 • 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.
|
0.00%
0/7 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place