Acute Myocardial Infarction, Cardiac Remodeling, Heart Failure, Pacing Therapy
Conditions
Brief summary
The purpose of this study is to demonstrate the feasibility of pacing as a therapy to prevent adverse remodeling of the myocardium following an acute myocardial infarction (MI) in patients at highest risk for adverse myocardial remodeling.
Interventions
DEVICESingle Site Pacing
Subjects will be implanted with a CRT-D that delivers pacing via the Left Ventricular lead.
DEVICEDual Site Pacing
Subjects will be implanted with a CRT-D that delivers pacing via the Left Ventricular and Right Ventricular lead.
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Myocardial Infarction (MI) within the past 10 days * Peak Creatine Phosphokinase (CPK) greater than 3000 Units/Litre (U/L) at time of MI, or a troponin T (TnT) greater than 10 micrograms/Litre (mcg/L) * At least 18 years old * Willing to comply with the protocol
Exclusion criteria
* Documented MI greater than 10 days * Chronic renal disease, as defined by estimated glomerular filtration rate (eGFR) less than 30 milliliters/minute/1.73 square meter * Life expectancy less than 18 months, as determined by a physician * Existing pacemaker, Implantable Cardioverter Defibrillator (ICD), or Cardiac Resynchronization Therapy (CRT) device * QRS duration greater than 120 milliseconds (ms) * Coronary Artery Bypass Graft (CABG) within 30 days prior to MI, or CABG procedure planned * Third degree atrioventricular (AV) block or symptomatic bradyarrhythmia * Persistent atrial fibrillation (AF) that is not self terminating within 7 days or is terminated electrically or pharmacologically * Permanent AF that is non self terminating, with cardioversion failed or not attempted within the past year * New York Heart Association (NYHA) Class IV * Non-ischemic cardiomyopathy * Pregnant or planning to become pregnant during the study * Enrolled or planning to participate in a concurrent drug and/or device study during the course of this clinical trial. Co-enrollment in concurrent trials is only allowed with documented pre-approval from Medtronic, documenting that there is not a concern that co-enrollment could confound the results of this trial. * Breast feeding * Of a vulnerable population as determined by local law or requirement, or a physician
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Left Ventricular End Diastolic Volume (LVEDV) | Baseline - 18 Month Follow Up Visit | Left ventricular end diastolic volume (LVEDV) was measured by echocardiogram. Change was measured as Month 18 LVEDV minus baseline LVEDV. Per protocol, change in LVEDV is compared between Pooled Pacing (Single site + Dual Site) and Control. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Hospitalization for Cardiovascular Events | Baseline - 18 Month Follow Up Visit | Number of hospitalizations related to cardiovascular events. |
| Change in New York Heart Association (NYHA) Functional Class | Baseline - 18 Month Follow Up Visit | The New York Heart Association (NYHA) score classifies patients' heart failure according to the severity of their symptoms. In particular, Class I: No limitation of physical activity. Class II: Slight limitation of physical activity. Class III: Marked limitation of physical activity. Class IV: Unable to carry on any physical activity without discomfort. NYHA change from baseline to 18-month visit. If a subject improved by one NYHA class or more (e.g. NYHA IV to NYHA II, or NYHA III to NYHA I, etc) from the baseline visit, the subject was classified as Improved. Similarly for Worsened (e.g. subject does not have heart failure to NYHA I, NYHA I to NYHA II, etc.). If the subjects' NYHA Class is not different than baseline, then the subject was classified as No Change. Per protocol, change in NYHA is compared between Pooled Pacing (Single site + Dual Site) and Control. |
| Change in 6-minute Walk Test Distance | 1 Month - 18 Month Follow Up Visit | Change in 6-minute hallwalk distance from 1-month visit to the 18-month visit. Change is defined as month 18 minus baseline. Per protocol, change in 6-minute walk test distance is compared between Pooled Pacing (Single site + Dual Site) and Control. |
| Safety of Implanting a Cardiac Resynchronization Therapy With Defibrillator (CRT-D) Device Within 10 Days of Myocardial Infarction (MI), as Measured by the Rate of Reported Adverse Events | 18 months post-implant | Survival estimates at 18 months post-implant for time to first following events: (a) System Related Adverse Event (b) System Related Complication (c) Procedure Related Adverse Event (d) Procedure Related Complication and (e) System Related or Procedure Related Complication. |
| Incidence of Sudden Cardiac Death and Total Mortality | 18 Months post-randomization | Mortality rates (%) for the events (a) all-cause death and (b) sudden-cardiac death at 18 months post randomization. Calculated using Kaplan-Meier methods. Per protocol the comparison of mortality rates is between Pooled Pacing (Dual Site + Single Site) and Control. |
| Linear Association Between Change in LVEDV and Selected Clinical Characteristics; Including Peak Creatinine Phosphokinase (CPK), Peak Troponin, Lead Location, Time From MI Onset to Implant, and Change in LV Volumes. | Baseline - 18 Month Follow Up Visit | Linear association between change in LVEDV from baseline to 18-month visit (i.e. ΔLVEDV) and the following clinical characteristics were assessed: age, days from MI to implant, gender, hypertension, hyperlipidemia, diabetes, peak CPK, infarct location, LV electrode in acceptable place, and baseline LVEF. In order to assess these linear associations, linear regression models were fitted for each of these clinical characteristics (separately). In particular, each linear regression model had baseline LVEDV and the clinical characteristic as covariates, and ΔLVEDV was the response variable. Variables resulting in statistical significant (p\<0.05) are reported. |
| Change in Quality of Life | Baseline - 18 Month Follow Up Visit | Change in the Minnesota Living with Heart Failure (MNLWHF) questionnaire from baseline to the 18-month follow-up visit. Change is defined as month 18 minus baseline. Per protocol change in MNLWHF is compared between Pooled Pacing (Dual Site + Single Site) and Control. |
Countries
Denmark, France, Germany, Hungary, Saudi Arabia, Slovakia, United States
Participant flow
Recruitment details
3 patients exited study prior to randomization.
Participants by arm
| Arm | Count |
|---|---|
| Single Site Pacing Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular lead. | 40 |
| Dual Site Pacing Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular and Right Ventricular lead. | 41 |
| Control Subjects randomized to the group that will not have a device implanted and will be managed according to conventional medical management. | 45 |
| Total | 126 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 2 | 1 | 2 |
| Overall Study | Exit | 3 | 2 | 8 |
| Overall Study | Missed 18-Month Follow-up | 0 | 0 | 1 |
| Overall Study | Protocol Violation | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | Single Site Pacing | Dual Site Pacing | Control | Total |
|---|---|---|---|---|
| Age, Continuous | 59 years STANDARD_DEVIATION 10 | 60 years STANDARD_DEVIATION 12 | 54 years STANDARD_DEVIATION 11 | 58 years STANDARD_DEVIATION 11 |
| BMI (kg/m^2) | 28 kg/m^2 STANDARD_DEVIATION 6 | 30 kg/m^2 STANDARD_DEVIATION 5 | 29 kg/m^2 STANDARD_DEVIATION 4 | 29 kg/m^2 STANDARD_DEVIATION 5 |
| Diastolic Blood Pressure (mmHg) | 73 mmHg STANDARD_DEVIATION 11 | 71 mmHg STANDARD_DEVIATION 12 | 74 mmHg STANDARD_DEVIATION 11 | 73 mmHg STANDARD_DEVIATION 11 |
| Heart Rate from Physical Exam (BPM) | 80 BPM STANDARD_DEVIATION 15 | 80 BPM STANDARD_DEVIATION 13 | 79 BPM STANDARD_DEVIATION 14 | 79 BPM STANDARD_DEVIATION 14 |
| Left Ventricular Ejection Fraction (LVEF) | 43 % STANDARD_DEVIATION 9 | 43 % STANDARD_DEVIATION 10 | 45 % STANDARD_DEVIATION 9 | 44 % STANDARD_DEVIATION 9 |
| Left Ventricular End Diastolic Volume (LVEDV) | 107 mL STANDARD_DEVIATION 25 | 107 mL STANDARD_DEVIATION 31 | 116 mL STANDARD_DEVIATION 29 | 111 mL STANDARD_DEVIATION 29 |
| Left Ventricular End Systolic Volume (LVESV) | 62 mL STANDARD_DEVIATION 23 | 62 mL STANDARD_DEVIATION 22 | 65 mL STANDARD_DEVIATION 24 | 63 mL STANDARD_DEVIATION 23 |
| Minnesota Living with Heart Failure Questionnaire (MLWHF) | 21 units on a scale STANDARD_DEVIATION 25 | 29 units on a scale STANDARD_DEVIATION 26 | 32 units on a scale STANDARD_DEVIATION 29 | 28 units on a scale STANDARD_DEVIATION 27 |
| NYHA I | 9 participants | 12 participants | 11 participants | 32 participants |
| NYHA II | 10 participants | 10 participants | 16 participants | 36 participants |
| NYHA III | 15 participants | 12 participants | 9 participants | 36 participants |
| NYHA IV | 0 participants | 0 participants | 0 participants | 0 participants |
| NYHA Missing | 0 participants | 0 participants | 1 participants | 1 participants |
| NYHA Subject does not have heart failure | 6 participants | 7 participants | 8 participants | 21 participants |
| QRS Width (msec) | 94 msec STANDARD_DEVIATION 17 | 97 msec STANDARD_DEVIATION 17 | 88 msec STANDARD_DEVIATION 13 | 93 msec STANDARD_DEVIATION 16 |
| Race/Ethnicity, Customized Asian | 0 participants | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Black or African American | 3 participants | 3 participants | 5 participants | 11 participants |
| Race/Ethnicity, Customized Hispanic or Latino | 0 participants | 1 participants | 3 participants | 4 participants |
| Race/Ethnicity, Customized Not reportable per local laws or regulations | 18 participants | 20 participants | 19 participants | 57 participants |
| Race/Ethnicity, Customized White or Caucasian | 19 participants | 16 participants | 18 participants | 53 participants |
| Sex: Female, Male Female | 12 Participants | 9 Participants | 12 Participants | 33 Participants |
| Sex: Female, Male Male | 28 Participants | 32 Participants | 33 Participants | 93 Participants |
| Systolic Blood Pressure (mmHg) | 114 mmHg STANDARD_DEVIATION 16 | 118 mmHg STANDARD_DEVIATION 21 | 119 mmHg STANDARD_DEVIATION 17 | 117 mmHg STANDARD_DEVIATION 18 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 20 / 40 | 25 / 41 | 27 / 45 |
| serious Total, serious adverse events | 22 / 40 | 24 / 41 | 20 / 45 |
Outcome results
Primary
Change in Left Ventricular End Diastolic Volume (LVEDV)
Left ventricular end diastolic volume (LVEDV) was measured by echocardiogram. Change was measured as Month 18 LVEDV minus baseline LVEDV. Per protocol, change in LVEDV is compared between Pooled Pacing (Single site + Dual Site) and Control.
Time frame: Baseline - 18 Month Follow Up Visit
Population: The primary analysis cohort for the main objective of this study (Change in Left Ventricular End Diastolic Volume) required a subject to be randomized, and if randomized to Dual Site or Single Site, the subject must have had a successful implant. Moreover, only subjects with observed LVEDV at baseline and 18-month follow-up visit are included.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Pooled Pacing | Change in Left Ventricular End Diastolic Volume (LVEDV) | 16.4 mL |
| Control | Change in Left Ventricular End Diastolic Volume (LVEDV) | 15.8 mL |
Secondary
Change in 6-minute Walk Test Distance
Change in 6-minute hallwalk distance from 1-month visit to the 18-month visit. Change is defined as month 18 minus baseline. Per protocol, change in 6-minute walk test distance is compared between Pooled Pacing (Single site + Dual Site) and Control.
Time frame: 1 Month - 18 Month Follow Up Visit
Population: Randomized subjects, and if randomized to Dual Site or Single Site, the subject must have had a successful implant. Moreover, only subjects with observed 6-minute hallwalk distance at baseline and 18-month follow-up visits are included.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Pooled Pacing | Change in 6-minute Walk Test Distance | 37.6 meters |
| Control | Change in 6-minute Walk Test Distance | 15.6 meters |
Secondary
Change in New York Heart Association (NYHA) Functional Class
The New York Heart Association (NYHA) score classifies patients' heart failure according to the severity of their symptoms. In particular, Class I: No limitation of physical activity. Class II: Slight limitation of physical activity. Class III: Marked limitation of physical activity. Class IV: Unable to carry on any physical activity without discomfort. NYHA change from baseline to 18-month visit. If a subject improved by one NYHA class or more (e.g. NYHA IV to NYHA II, or NYHA III to NYHA I, etc) from the baseline visit, the subject was classified as Improved. Similarly for Worsened (e.g. subject does not have heart failure to NYHA I, NYHA I to NYHA II, etc.). If the subjects' NYHA Class is not different than baseline, then the subject was classified as No Change. Per protocol, change in NYHA is compared between Pooled Pacing (Single site + Dual Site) and Control.
Time frame: Baseline - 18 Month Follow Up Visit
Population: Subject was randomized, and if randomized to Dual Site or Single Site, the subject must have had a successful implant. Moreover, only subjects with observed NYHA at baseline and 18-month follow-up visit are included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pooled Pacing | Change in New York Heart Association (NYHA) Functional Class | Worsened | 17 participants |
| Pooled Pacing | Change in New York Heart Association (NYHA) Functional Class | Improved | 26 participants |
| Pooled Pacing | Change in New York Heart Association (NYHA) Functional Class | No Change | 25 participants |
| Control | Change in New York Heart Association (NYHA) Functional Class | Worsened | 10 participants |
| Control | Change in New York Heart Association (NYHA) Functional Class | Improved | 13 participants |
| Control | Change in New York Heart Association (NYHA) Functional Class | No Change | 10 participants |
Secondary
Change in Quality of Life
Change in the Minnesota Living with Heart Failure (MNLWHF) questionnaire from baseline to the 18-month follow-up visit. Change is defined as month 18 minus baseline. Per protocol change in MNLWHF is compared between Pooled Pacing (Dual Site + Single Site) and Control.
Time frame: Baseline - 18 Month Follow Up Visit
Population: Randomized subjects, and if randomized to Dual Site or Single Site, the subject must have had a successful implant. Moreover, only subjects with observed MNLWHF questionnaire score at baseline and 18-month follow-up visits are included.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Pooled Pacing | Change in Quality of Life | 0.4 units on a scale |
| Control | Change in Quality of Life | -0.1 units on a scale |
Secondary
Frequency of Hospitalization for Cardiovascular Events
Number of hospitalizations related to cardiovascular events.
Time frame: Baseline - 18 Month Follow Up Visit
Population: Subject was randomized, and if randomized to Dual Site or Single Site, the subject must have had a successful implant.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pooled Pacing | Frequency of Hospitalization for Cardiovascular Events | 5 | 1 participants |
| Pooled Pacing | Frequency of Hospitalization for Cardiovascular Events | 7 | 0 participants |
| Pooled Pacing | Frequency of Hospitalization for Cardiovascular Events | 9 | 0 participants |
| Pooled Pacing | Frequency of Hospitalization for Cardiovascular Events | 8 | 0 participants |
| Pooled Pacing | Frequency of Hospitalization for Cardiovascular Events | 0 | 27 participants |
| Pooled Pacing | Frequency of Hospitalization for Cardiovascular Events | 1 | 6 participants |
| Pooled Pacing | Frequency of Hospitalization for Cardiovascular Events | 2 | 3 participants |
| Pooled Pacing | Frequency of Hospitalization for Cardiovascular Events | 4 | 0 participants |
| Pooled Pacing | Frequency of Hospitalization for Cardiovascular Events | 3 | 1 participants |
| Pooled Pacing | Frequency of Hospitalization for Cardiovascular Events | 6 | 0 participants |
| Control | Frequency of Hospitalization for Cardiovascular Events | 4 | 0 participants |
| Control | Frequency of Hospitalization for Cardiovascular Events | 6 | 0 participants |
| Control | Frequency of Hospitalization for Cardiovascular Events | 2 | 3 participants |
| Control | Frequency of Hospitalization for Cardiovascular Events | 7 | 0 participants |
| Control | Frequency of Hospitalization for Cardiovascular Events | 1 | 9 participants |
| Control | Frequency of Hospitalization for Cardiovascular Events | 5 | 1 participants |
| Control | Frequency of Hospitalization for Cardiovascular Events | 8 | 1 participants |
| Control | Frequency of Hospitalization for Cardiovascular Events | 3 | 1 participants |
| Control | Frequency of Hospitalization for Cardiovascular Events | 9 | 0 participants |
| Control | Frequency of Hospitalization for Cardiovascular Events | 0 | 22 participants |
| Control | Frequency of Hospitalization for Cardiovascular Events | 9 | 1 participants |
| Control | Frequency of Hospitalization for Cardiovascular Events | 5 | 0 participants |
| Control | Frequency of Hospitalization for Cardiovascular Events | 0 | 30 participants |
| Control | Frequency of Hospitalization for Cardiovascular Events | 1 | 11 participants |
| Control | Frequency of Hospitalization for Cardiovascular Events | 2 | 0 participants |
| Control | Frequency of Hospitalization for Cardiovascular Events | 4 | 0 participants |
| Control | Frequency of Hospitalization for Cardiovascular Events | 6 | 0 participants |
| Control | Frequency of Hospitalization for Cardiovascular Events | 7 | 0 participants |
| Control | Frequency of Hospitalization for Cardiovascular Events | 8 | 0 participants |
| Control | Frequency of Hospitalization for Cardiovascular Events | 3 | 3 participants |
Secondary
Incidence of Sudden Cardiac Death and Total Mortality
Mortality rates (%) for the events (a) all-cause death and (b) sudden-cardiac death at 18 months post randomization. Calculated using Kaplan-Meier methods. Per protocol the comparison of mortality rates is between Pooled Pacing (Dual Site + Single Site) and Control.
Time frame: 18 Months post-randomization
Population: Randomized subjects, and if randomized to Dual Site or Single Site, the subject must have had a successful implant.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pooled Pacing | Incidence of Sudden Cardiac Death and Total Mortality | All-cause Death | 4.0 percentage of subjects at risk |
| Pooled Pacing | Incidence of Sudden Cardiac Death and Total Mortality | Sudden-cardiac Death | 1.4 percentage of subjects at risk |
| Control | Incidence of Sudden Cardiac Death and Total Mortality | All-cause Death | 4.7 percentage of subjects at risk |
| Control | Incidence of Sudden Cardiac Death and Total Mortality | Sudden-cardiac Death | 2.4 percentage of subjects at risk |
Secondary
Linear Association Between Change in LVEDV and Selected Clinical Characteristics; Including Peak Creatinine Phosphokinase (CPK), Peak Troponin, Lead Location, Time From MI Onset to Implant, and Change in LV Volumes.
Linear association between change in LVEDV from baseline to 18-month visit (i.e. ΔLVEDV) and the following clinical characteristics were assessed: age, days from MI to implant, gender, hypertension, hyperlipidemia, diabetes, peak CPK, infarct location, LV electrode in acceptable place, and baseline LVEF. In order to assess these linear associations, linear regression models were fitted for each of these clinical characteristics (separately). In particular, each linear regression model had baseline LVEDV and the clinical characteristic as covariates, and ΔLVEDV was the response variable. Variables resulting in statistical significant (p\<0.05) are reported.
Time frame: Baseline - 18 Month Follow Up Visit
Population: All subjects randomized, and if randomized to Dual Site or Single Site, the subject must have had a successful implant. Moreover, only subjects with observed LVEDV at baseline and 18-month follow-up visit are included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pooled Pacing | Linear Association Between Change in LVEDV and Selected Clinical Characteristics; Including Peak Creatinine Phosphokinase (CPK), Peak Troponin, Lead Location, Time From MI Onset to Implant, and Change in LV Volumes. | Age | -0.75 regression coefficient | Standard Error 0.26 |
| Pooled Pacing | Linear Association Between Change in LVEDV and Selected Clinical Characteristics; Including Peak Creatinine Phosphokinase (CPK), Peak Troponin, Lead Location, Time From MI Onset to Implant, and Change in LV Volumes. | Days from MI to Implant* | -3.78 regression coefficient | Standard Error 1.64 |
| Pooled Pacing | Linear Association Between Change in LVEDV and Selected Clinical Characteristics; Including Peak Creatinine Phosphokinase (CPK), Peak Troponin, Lead Location, Time From MI Onset to Implant, and Change in LV Volumes. | Baseline LVEF | -0.87 regression coefficient | Standard Error 0.35 |
Secondary
Safety of Implanting a Cardiac Resynchronization Therapy With Defibrillator (CRT-D) Device Within 10 Days of Myocardial Infarction (MI), as Measured by the Rate of Reported Adverse Events
Survival estimates at 18 months post-implant for time to first following events: (a) System Related Adverse Event (b) System Related Complication (c) Procedure Related Adverse Event (d) Procedure Related Complication and (e) System Related or Procedure Related Complication.
Time frame: 18 months post-implant
Population: Only subjects with attempt implant are included. Therefore, subjects from the Control Arm are not included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pooled Pacing | Safety of Implanting a Cardiac Resynchronization Therapy With Defibrillator (CRT-D) Device Within 10 Days of Myocardial Infarction (MI), as Measured by the Rate of Reported Adverse Events | System Related Complication | 0.86 survival probability |
| Pooled Pacing | Safety of Implanting a Cardiac Resynchronization Therapy With Defibrillator (CRT-D) Device Within 10 Days of Myocardial Infarction (MI), as Measured by the Rate of Reported Adverse Events | Procedure Related Complication | 0.84 survival probability |
| Pooled Pacing | Safety of Implanting a Cardiac Resynchronization Therapy With Defibrillator (CRT-D) Device Within 10 Days of Myocardial Infarction (MI), as Measured by the Rate of Reported Adverse Events | Procedure Related Adverse Event | 0.57 survival probability |
| Pooled Pacing | Safety of Implanting a Cardiac Resynchronization Therapy With Defibrillator (CRT-D) Device Within 10 Days of Myocardial Infarction (MI), as Measured by the Rate of Reported Adverse Events | System Related or Procedure Related Complication | 0.79 survival probability |
| Pooled Pacing | Safety of Implanting a Cardiac Resynchronization Therapy With Defibrillator (CRT-D) Device Within 10 Days of Myocardial Infarction (MI), as Measured by the Rate of Reported Adverse Events | System-Related Adverse Event | 0.59 survival probability |
| Control | Safety of Implanting a Cardiac Resynchronization Therapy With Defibrillator (CRT-D) Device Within 10 Days of Myocardial Infarction (MI), as Measured by the Rate of Reported Adverse Events | System Related or Procedure Related Complication | 0.82 survival probability |
| Control | Safety of Implanting a Cardiac Resynchronization Therapy With Defibrillator (CRT-D) Device Within 10 Days of Myocardial Infarction (MI), as Measured by the Rate of Reported Adverse Events | System-Related Adverse Event | 0.68 survival probability |
| Control | Safety of Implanting a Cardiac Resynchronization Therapy With Defibrillator (CRT-D) Device Within 10 Days of Myocardial Infarction (MI), as Measured by the Rate of Reported Adverse Events | System Related Complication | 0.87 survival probability |
| Control | Safety of Implanting a Cardiac Resynchronization Therapy With Defibrillator (CRT-D) Device Within 10 Days of Myocardial Infarction (MI), as Measured by the Rate of Reported Adverse Events | Procedure Related Adverse Event | 0.66 survival probability |
| Control | Safety of Implanting a Cardiac Resynchronization Therapy With Defibrillator (CRT-D) Device Within 10 Days of Myocardial Infarction (MI), as Measured by the Rate of Reported Adverse Events | Procedure Related Complication | 0.84 survival probability |