Primary Prevention of Sudden Cardiac Arrest
Conditions
Keywords
Inappropriate therapy, ICD therapy, Primary prevention
Brief summary
This study will assess the impact of higher rate cutoffs and longer delays than standard programming on inappropriate therapy in primary prevention ICD and CRT-D patients.
Detailed description
The purpose of the MADIT-RIT trial is to compare the time to first inappropriate therapy using high rate cutoff and/or long delay in primary prevention patients receiving an ICD or CRT-D device compared to standard programming.
Interventions
DEVICEStandard ICD programming
Standard ICD programming
DEVICEHigh rate cutoff
Programming of a high rate cutoff
DEVICELong delay
Programming of a prolonged delay
Sponsors
Boston Scientific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Primary prevention patient with ischemic or non-ischemic heart disease who meets current guidelines for dual-chamber ICD or CRT-D device therapy * Patient in sinus rhythm * Patient on stable optimal pharmacologic therapy for the cardiac condition or who has developed a recent ICD indication that necessitates ICD therapy concurrent with the optimization of pharmacologic therapy * Patient ≥ 21 years of age, or legal representative, willing and capable of giving informed consent
Exclusion criteria
* Patient with an implanted pacemaker or CRT-P * Patient with existing ICD or CRT-D device components * Patient with a history of VT or VF * Patient with permanent or chronic AF, or cardioversion for AF, within the past three calendar months before enrollment * Patient with coronary artery bypass graft surgery or percutaneous coronary intervention within the past three calendar months prior to enrollment * Patient with enzyme-positive myocardial infarction within the past three calendar months prior to enrollment * Patient with angiographic evidence of coronary disease who are candidates for coronary revascularization and are likely to undergo coronary artery bypass graft surgery or percutaneous coronary intervention in the foreseeable future * Patient with second or third degree heart block * Patient in NYHA Class IV * Patient who is pregnant or plans to become pregnant during the course of the trial * Patient with irreversible brain damage from preexisting cerebral disease * Patient with presence of any disease, other than the patient's cardiac disease, associated with a reduced likelihood of survival for the duration of the trial, e.g., cancer, uremia, liver failure, etc. * Patient with chronic renal disease with BUN ≥ 50mg/dl or creatinine ≥ 2.5 mg/dl * Patient participating in any other clinical trial * Patient unwilling or unable to cooperate with the protocol * Patient who lives at such a distance from the clinic that travel for follow-up visits would be unusually difficult * Patient who does not anticipate being a resident of the area for the scheduled duration of the trial * Patient unwilling to sign the consent for participation * Patient whose physician does not allow participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inappropriate ICD Therapy | Average of 1.4 years follow-up | First occurance of inappropriate therapy (either anti-tachycardia pacing or shock) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause Mortality | Average 1.4 years of follow-up | — |
| Syncope | Average of 1.4 years follow-up | First episode of syncope |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| A - Standard ICD Programming Standard ICD Programming
Standard ICD programming : Standard ICD programming | 514 |
| B - High Rate Cutoff High rate cutoff
High rate cutoff : Programming of a high rate cutoff | 500 |
| C - Long ICD Duration Delay Long ICD duration delay
Long delay : Programming of a prolonged delay | 486 |
| Total | 1,500 |
Baseline characteristics
| Characteristic | A - Standard ICD Programming | B - High Rate Cutoff | C - Long ICD Duration Delay | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 262 Participants | 255 Participants | 232 Participants | 749 Participants |
| Age, Categorical Between 18 and 65 years | 252 Participants | 245 Participants | 254 Participants | 751 Participants |
| Age, Continuous | 63 years STANDARD_DEVIATION 11 | 63 years STANDARD_DEVIATION 12 | 62 years STANDARD_DEVIATION 12 | 63 years STANDARD_DEVIATION 12 |
| Region of Enrollment Canada | 11 participants | 12 participants | 12 participants | 35 participants |
| Region of Enrollment Europe | 94 participants | 92 participants | 91 participants | 277 participants |
| Region of Enrollment Israel | 34 participants | 36 participants | 34 participants | 104 participants |
| Region of Enrollment Japan | 22 participants | 22 participants | 24 participants | 68 participants |
| Region of Enrollment United States | 353 participants | 338 participants | 325 participants | 1016 participants |
| Sex: Female, Male Female | 157 Participants | 146 Participants | 133 Participants | 436 Participants |
| Sex: Female, Male Male | 357 Participants | 354 Participants | 353 Participants | 1064 Participants |
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 | 207 / 514 | 136 / 500 | 121 / 486 |
| serious Total, serious adverse events | 446 / 514 | 380 / 500 | 394 / 486 |
Outcome results
Primary
Inappropriate ICD Therapy
First occurance of inappropriate therapy (either anti-tachycardia pacing or shock)
Time frame: Average of 1.4 years follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| A - Standard ICD Programming | Inappropriate ICD Therapy | 105 participants |
| B - High Rate Cutoff | Inappropriate ICD Therapy | 21 participants |
| C - Long ICD Duration Delay | Inappropriate ICD Therapy | 26 participants |
Comparison: Hazard ratios (HR) were calculated to compare Arm A vs Arm B. Null Hypothesis was that HR = 1p-value: <0.00195% CI: [0.13, 0.34]Regression, Cox
Comparison: Hazard ratios (HR) were calculated to compare Arm A vs Arm C. Null Hypothesis was that HR = 1p-value: <0.00195% CI: [0.15, 0.4]Regression, Cox
Secondary
All-cause Mortality
Time frame: Average 1.4 years of follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| A - Standard ICD Programming | All-cause Mortality | 34 participants |
| B - High Rate Cutoff | All-cause Mortality | 16 participants |
| C - Long ICD Duration Delay | All-cause Mortality | 21 participants |
Comparison: Hazard ratios (HR) were calculated to compare Arm A vs Arm B. Null Hypothesis was that HR = 1p-value: 0.0195% CI: [0.24, 0.85]Regression, Cox
Comparison: Hazard ratios (HR) were calculated to compare Arm A vs Arm C. Null Hypothesis was that HR = 1p-value: 0.0695% CI: [0.3, 1.02]Regression, Cox
Secondary
Syncope
First episode of syncope
Time frame: Average of 1.4 years follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| A - Standard ICD Programming | Syncope | 23 participants |
| B - High Rate Cutoff | Syncope | 22 participants |
| C - Long ICD Duration Delay | Syncope | 22 participants |
Comparison: Hazard ratios (HR) were calculated to compare Arm A vs Arm B. Null Hypothesis was that HR = 1p-value: 0.3995% CI: [0.71, 2.47]Regression, Cox
Comparison: Hazard ratios (HR) were calculated to compare Arm A vs Arm C. Null Hypothesis was that HR = 1p-value: 0.895% CI: [0.58, 2.05]Regression, Cox