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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Standard ICD Programming |
|
| B | Experimental | High rate cutoff |
|
| C | Experimental | Long ICD duration delay |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard ICD programming | Device | Standard ICD programming |
| |
| High rate cutoff |
| Measure | Description | Time Frame |
|---|---|---|
| Inappropriate ICD Therapy | First occurance of inappropriate therapy (either anti-tachycardia pacing or shock) | Average of 1.4 years follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause Mortality | Average 1.4 years of follow-up | |
| Syncope | First episode of syncope | Average of 1.4 years follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arthur J Moss, MD | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester (Multiple Facilities Participating World Wide) | Rochester | New York | 14642 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22816536 | Background | Schuger C, Daubert JP, Brown MW, Cannom D, Estes NA 3rd, Hall WJ, Kayser T, Klein H, Olshansky B, Power KA, Wilber D, Zareba W, Moss AJ. Multicenter automatic defibrillator implantation trial: reduce inappropriate therapy (MADIT-RIT): background, rationale, and clinical protocol. Ann Noninvasive Electrocardiol. 2012 Jul;17(3):176-85. doi: 10.1111/j.1542-474X.2012.00531.x. | |
| 31765809 |
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| ID | Title | Description |
|---|---|---|
| FG000 | A - Standard ICD Programming | Standard ICD Programming Standard ICD programming : Standard ICD programming |
| FG001 | B - High Rate Cutoff | High rate cutoff High rate cutoff : Programming of a high rate cutoff |
| FG002 | C - Long ICD Duration Delay | Long ICD duration delay Long delay : Programming of a prolonged delay |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | A - Standard ICD Programming | Standard ICD Programming Standard ICD programming : Standard ICD programming |
| BG001 | B - High Rate Cutoff | High rate cutoff High rate cutoff : Programming of a high rate cutoff |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | All-cause Mortality | Posted | Number | participants | Average 1.4 years of follow-up |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | A - Standard ICD Programming | Standard ICD Programming Standard ICD programming : Standard ICD programming |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematological | Blood and lymphatic system disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Extracardiac Stimulation, Left Ventricular | Cardiac disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Arthur J. Moss | University of Rochester, Heart Research Follow-up Program | 585-275-5391 | arthur.moss@heart.rochester.edu |
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| Device |
Programming of a high rate cutoff |
|
| Long delay | Device | Programming of a prolonged delay |
|
| Derived |
| Younis A, Heist EK, McNitt S, Aktas MK, Rosero S, Goldenberg I, Kutyifa V. Predictors and outcomes of atrial tachyarrhythmia among patients with implantable defibrillators. Heart Rhythm. 2020 Apr;17(4):553-559. doi: 10.1016/j.hrthm.2019.11.024. Epub 2019 Nov 22. |
| 29978932 | Derived | Jackson LR 2nd, Thomas KL, Polonsky B, Zareba W, Lahiri M, Saba S, McNitt S, Schuger C, Daubert JP, Moss AJ, Kutyifa V. Effectiveness of high rate and delayed detection ICD programming by race: A MADIT-RIT substudy. J Cardiovasc Electrophysiol. 2018 Oct;29(10):1418-1424. doi: 10.1111/jce.13693. Epub 2018 Jul 24. |
| 26743237 | Derived | Kutyifa V, Daubert JP, Schuger C, Goldenberg I, Klein H, Aktas MK, McNitt S, Stockburger M, Merkely B, Zareba W, Moss AJ. Novel ICD Programming and Inappropriate ICD Therapy in CRT-D Versus ICD Patients: A MADIT-RIT Sub-Study. Circ Arrhythm Electrophysiol. 2016 Jan;9(1):e001965. doi: 10.1161/CIRCEP.114.001965. |
| 26001510 | Derived | Kutyifa V, Daubert JP, Olshansky B, Huang DT, Zhang C, Ruwald AC, McNitt S, Zareba W, Moss AJ, Schuger C. Characterization and predictors of first and subsequent inappropriate ICD therapy by heart rate ranges: Result of the MADIT-RIT efficacy analysis. Heart Rhythm. 2015 Sep;12(9):2030-7. doi: 10.1016/j.hrthm.2015.05.021. Epub 2015 May 19. |
| 25917337 | Derived | Kutyifa V, Moss AJ, Schuger C, McNitt S, Polonsky B, Ruwald AH, Ruwald MH, Daubert JP, Zareba W. Reduction in Inappropriate ICD Therapy in MADIT-RIT Patients Without History of Atrial Tachyarrhythmia. J Cardiovasc Electrophysiol. 2015 Aug;26(8):879-884. doi: 10.1111/jce.12692. Epub 2015 Jun 15. |
| 25745075 | Derived | Stockburger M, Moss AJ, Olshansky B, Klein H, McNitt S, Schuger C, Daubert JP, Goldenberg I, Ruwald AC, Merkely B, Zareba W, Kutyifa V. Time-dependent risk reduction of ventricular tachyarrhythmias in cardiac resynchronization therapy patients: a MADIT-RIT sub-study. Europace. 2015 Jul;17(7):1085-91. doi: 10.1093/europace/euv008. Epub 2015 Mar 4. |
| 25546486 | Derived | Sedlacek K, Ruwald AC, Kutyifa V, McNitt S, Thomsen PEB, Klein H, Stockburger M, Wichterle D, Merkely B, DE LA Concha JF, Swissa M, Zareba W, Moss AJ, Kautzner J, Ruwald MH; MADIT-RIT Investigators. The effect of ICD programming on inappropriate and appropriate ICD Therapies in ischemic and nonischemic cardiomyopathy: the MADIT-RIT trial. J Cardiovasc Electrophysiol. 2015 Apr;26(4):424-433. doi: 10.1111/jce.12605. Epub 2015 Feb 11. |
| 25136077 | Derived | Ruwald AC, Schuger C, Moss AJ, Kutyifa V, Olshansky B, Greenberg H, Cannom DS, Estes NA, Ruwald MH, Huang DT, Klein H, McNitt S, Beck CA, Goldstein R, Brown MW, Kautzner J, Shoda M, Wilber D, Zareba W, Daubert JP. Mortality reduction in relation to implantable cardioverter defibrillator programming in the Multicenter Automatic Defibrillator Implantation Trial-Reduce Inappropriate Therapy (MADIT-RIT). Circ Arrhythm Electrophysiol. 2014 Oct;7(5):785-92. doi: 10.1161/CIRCEP.114.001623. Epub 2014 Aug 18. |
| 24201303 | Derived | Ruwald MH, Okumura K, Kimura T, Aonuma K, Shoda M, Kutyifa V, Ruwald AC, McNitt S, Zareba W, Moss AJ. Syncope in high-risk cardiomyopathy patients with implantable defibrillators: frequency, risk factors, mechanisms, and association with mortality: results from the multicenter automatic defibrillator implantation trial-reduce inappropriate therapy (MADIT-RIT) study. Circulation. 2014 Feb 4;129(5):545-52. doi: 10.1161/CIRCULATIONAHA.113.004196. Epub 2013 Nov 7. |
| 23881862 | Derived | Ruwald MH, Zareba W, Jons C, Zhang C, Ruwald AC, Olshansky B, McNitt S, Bloch Thomsen PE, Shoda M, Merkely B, Moss AJ, Kutyifa V. Influence of diabetes mellitus on inappropriate and appropriate implantable cardioverter-defibrillator therapy and mortality in the Multicenter Automatic Defibrillator Implantation Trial-Reduce Inappropriate Therapy (MADIT-RIT) Trial. Circulation. 2013 Aug 13;128(7):694-701. doi: 10.1161/CIRCULATIONAHA.113.002472. Epub 2013 Jul 23. |
| 23131066 | Derived | Moss AJ, Schuger C, Beck CA, Brown MW, Cannom DS, Daubert JP, Estes NA 3rd, Greenberg H, Hall WJ, Huang DT, Kautzner J, Klein H, McNitt S, Olshansky B, Shoda M, Wilber D, Zareba W; MADIT-RIT Trial Investigators. Reduction in inappropriate therapy and mortality through ICD programming. N Engl J Med. 2012 Dec 13;367(24):2275-83. doi: 10.1056/NEJMoa1211107. Epub 2012 Nov 6. |
| BG002 | C - Long ICD Duration Delay | Long ICD duration delay Long delay : Programming of a prolonged delay |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Syncope | First episode of syncope | Posted | Number | participants | Average of 1.4 years follow-up |
|
|
|
|
| Primary | Inappropriate ICD Therapy | First occurance of inappropriate therapy (either anti-tachycardia pacing or shock) | Posted | Number | participants | Average of 1.4 years follow-up |
|
|
|
|
| 446 |
| 514 |
| 207 |
| 514 |
| EG001 | B - High Rate Cutoff | High rate cutoff High rate cutoff : Programming of a high rate cutoff | 380 | 500 | 136 | 500 |
| EG002 | C - Long ICD Duration Delay | Long ICD duration delay Long delay : Programming of a prolonged delay | 394 | 486 | 121 | 486 |
| Hematoma | Blood and lymphatic system disorders |
|
| Hemorrhage | Blood and lymphatic system disorders |
|
| Thromboembolic events | Blood and lymphatic system disorders |
|
| Extracardiac Stimulation, Left Ventricular | Cardiac disorders |
|
| Lead Dislodgment, Left Ventricular | Cardiac disorders |
|
| Threshold Related, Left Ventricular | Cardiac disorders |
|
| Pulse Generator-System, Patient-Other | Cardiac disorders |
|
| Pacemaker-mediated Tachycardia (PMT) | Cardiac disorders |
|
| Premature Ventricular Contractions (PVC) | Cardiac disorders |
|
| Unable to Communicate with Pulse Generator | Cardiac disorders |
|
| Elevated Threshold, Right Atrial | Cardiac disorders |
|
| Lead Dislodgment, Right Atrial | Cardiac disorders |
|
| Lead Related, Right Atrial | Cardiac disorders |
|
| Sensing Related, Right Atrial | Cardiac disorders |
|
| Lead Dislodgment, Right Ventricular | Cardiac disorders |
|
| Lead Related, Right Ventricular | Cardiac disorders |
|
| Sensing Related, Right Ventricular | Cardiac disorders |
|
| Threshold Related, Right Ventricular | Cardiac disorders |
|
| Cardiac Arrest | Cardiac disorders |
|
| Cardiogenic Shock | Cardiac disorders |
|
| Chest Pain, Ischemic | Cardiac disorders |
|
| Chest Pain, Other | Cardiac disorders |
|
| Pulse Generator Erosion | Cardiac disorders |
|
| Heart Failure Symptoms | Cardiac disorders |
|
| Hypertension | Cardiac disorders |
|
| Hypotension | Cardiac disorders |
|
| Inappropriate Tachy Therapy | Cardiac disorders |
|
| Inadvertant Tachy Arrhythmia | Cardiac disorders |
|
| Pulse Generator Migration | Cardiac disorders |
|
| Myocardial Infarction | Cardiac disorders |
|
| Cardiovascular, Patient Condition | Cardiac disorders |
|
| Palpitations | Cardiac disorders |
|
| Pericarditis | Cardiac disorders |
|
| Pericardial Effusion | Cardiac disorders |
|
| Supraventricular Tachy Arrhythmia | Cardiac disorders |
|
| Valvular Related | Cardiac disorders |
|
| Ventricular Arrhythmias | Cardiac disorders |
|
| Syncope, Cardiac Related | Cardiac disorders |
|
| Endocrine Related | Endocrine disorders |
|
| Gastrointestinal Related | Gastrointestinal disorders |
|
| Abnormal Laboratory Value | General disorders |
|
| Death | General disorders | This is not a complete listing of reported deaths, others are reported within other adverse event categories with a result in death. |
|
| Dizziness | General disorders |
|
| Fatigue | General disorders |
|
| Fever | General disorders |
|
| Head, Eyes, Ears, Nose, Throat (HEENT) | General disorders |
|
| Multi-System Failure | General disorders |
|
| Related to Multiple Symptoms | General disorders |
|
| Non-Cardiovascular, Patient Condition | General disorders |
|
| Physical Trauma | General disorders |
|
| Psychological | General disorders |
|
| Cancer | General disorders |
|
| Syncope, General | General disorders |
|
| Immune | Immune system disorders |
|
| Systemic Infection | Infections and infestations |
|
| Musculoskeletal | Musculoskeletal and connective tissue disorders |
|
| Neurological | Nervous system disorders |
|
| Syncope, Neurological Related | Nervous system disorders |
|
| Genitourinary | Renal and urinary disorders |
|
| Renal | Renal and urinary disorders |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders |
|
| Pulmonary | Respiratory, thoracic and mediastinal disorders |
|
| Integumentary | Skin and subcutaneous tissue disorders |
|
| Myocardial Perforation, Post-Implant, Right Ventricular | Surgical and medical procedures |
|
| Seroma, Pocket (<= 30 days Post Pulse Generator Implant) | Surgical and medical procedures |
|
| Adverse Reaction, Implant Procedure Related | Surgical and medical procedures |
|
| Bleeding, Implant Procedure Related | Surgical and medical procedures |
|
| Coronary Venous Trauma | Surgical and medical procedures |
|
| Hematoma, Pulse Generator Pocket (>30 days Post Device Implant) | Surgical and medical procedures |
|
| Infection, (> 30 days Post Device Implant) | Surgical and medical procedures |
|
| Pneumothorax, Procedure Related | Surgical and medical procedures |
|
| Post Surgical Wound Discomfort | Surgical and medical procedures |
|
| Post Surgical Infection (<= 30 days Post Device Implant) | Surgical and medical procedures |
|
| Post Surgical Pocket Hemorrhage | Surgical and medical procedures |
|
| Venous Occlusion | Surgical and medical procedures |
|
| Vascular Related | Vascular disorders |
|
| Heart Failure Symptoms | Cardiac disorders |
|
| Inappropriate Tachy Therapy | Cardiac disorders |
|
| Pacemaker-mediated Tachycardia (PMT) | Cardiac disorders |
|
| Supraventricular Tachy Arrhythmia | Cardiac disorders |
|
| Ventricular Tachyarrhythmia | Cardiac disorders |
|
Not provided
| Regression, Cox |
| 0.80 |
| Hazard Ratio (HR) |
| 1.09 |
| 2-Sided |
| 95 |
| 0.58 |
| 2.05 |
| Superiority or Other |
| Regression, Cox |
| <0.001 |
| Hazard Ratio (HR) |
| 0.24 |
| 2-Sided |
| 95 |
| 0.15 |
| 0.40 |
| Superiority or Other |