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MADIT-CRT PAR is an FDA mandated follow-up registry for patients that participated in the MADIT-CRT IDE study examining long-term mortality.
(MADIT-CRT IDE: NCT00180271)
The registry is designed to determine the long-term mortality benefit as a result of Cardiac Resynchronization Therapy with Defibrillation (CRT-D) vs. Implantable Cardioverter Defibrillator (ICD) therapy in the MADIT-CRT study patient population. The registry will collect data on patients that previously participated at MADIT-CRT sites within the US through five years of participation from their orginal enrollment in the MADIT-CRT IDE study (MADIT-CRT IDE: NCT00180271).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MADIT-CRT ICD |
| ||
| MADIT-CRT CRT-D |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MADIT-CRT ICD | Device | Patients that were randomized to the the implantable cardioverter defibrillator (ICD) device for the study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| All-Cause Mortality | Outcome measured for total population. Not broken down by indication received. | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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The registry involves only those patients that participated in the MADIT-CRT IDE study within the United States.
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| Name | Affiliation | Role |
|---|---|---|
| Arthur J Moss, MD | University of Rochester Heart Research Follow-up Program | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester /Strong Memorial | Rochester | New York | 14642 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32605387 | Derived | Vidula H, Lee E, McNitt S, Polonsky B, Aktas M, Rosero S, Younis A, Solomon SD, Zareba W, Kutyifa V, Goldenberg I. Cardiac Resynchronization Therapy and Risk of Recurrent Hospitalizations in Patients Without Left Bundle Branch Block: The Long-Term Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy. Circ Heart Fail. 2020 Jul;13(7):e006925. doi: 10.1161/CIRCHEARTFAILURE.120.006925. Epub 2020 Jul 1. | |
| 30592353 |
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For this trial permission was received by several institutional review boards to include subjects death information for participants in the MADIT-CRT IDE (NCT00180271) who died between the end of the IDE and the start of the Registry. This includes 14 subjects, 7 from each arm.
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| ID | Title | Description |
|---|---|---|
| FG000 | MADIT-CRT ICD | MADIT-CRT ICD: Patients that were randomized to the the implantable cardioverter defibrillator (ICD) device for the study. |
| FG001 | MADIT-CRT CRT-D | MADIT-CRT CRT-D: Patients that were randomized to the the cardiac resynchronization therapy with defibrillation (CRT-D) device for the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All subjects enrolled into the Reigstry were previous participants in the MADIT-CRT trial, the baseline characteristics did not pertain to the entry into the Registry.
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| ID | Title | Description |
|---|---|---|
| BG000 | MADIT-CRT ICD | MADIT-CRT ICD: Patients that were randomized to the the implantable cardioverter defibrillator (ICD) device for the study. |
| BG001 | MADIT-CRT CRT-D | MADIT-CRT CRT-D: Patients that were randomized to the the cardiac resynchronization therapy with defibrillation (CRT-D) device for the study. |
| 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 | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | All-Cause Mortality | Outcome measured for total population. Not broken down by indication received. | Posted | Number | participants | 5 years |
|
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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 | MADIT-CRT ICD | MADIT-CRT ICD: Patients that were randomized to the the implantable cardioverter defibrillator (ICD) device for the study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Laboratory Values - Abnormal | Metabolism and nutrition disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Heart Failure Symptoms | Cardiac disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Arthur Moss | University of Rochester Heart Research Follow-up Program | 585-275-5291 | Arthur.Moss@heart.rochester.edu |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| MADIT-CRT CRT-D | Device | Patients that were randomized to the the cardiac resynchronization therapy with defibrillation (CRT-D) device for the study. |
|
|
| Derived |
| Kutyifa V, Vermilye K, Solomon SD, McNitt S, Moss AJ, Daimee UA. Long-term outcomes of cardiac resynchronization therapy by left ventricular ejection fraction. Eur J Heart Fail. 2019 Mar;21(3):360-369. doi: 10.1002/ejhf.1357. Epub 2018 Dec 28. |
| 26823498 | Derived | Biton Y, Kutyifa V, Cygankiewicz I, Goldenberg I, Klein H, McNitt S, Polonsky B, Ruwald AC, Ruwald MH, Moss AJ, Zareba W. Relation of QRS Duration to Clinical Benefit of Cardiac Resynchronization Therapy in Mild Heart Failure Patients Without Left Bundle Branch Block: The Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy Substudy. Circ Heart Fail. 2016 Feb;9(2):e002667. doi: 10.1161/CIRCHEARTFAILURE.115.002667. |
| 26124205 | Derived | Biton Y, Zareba W, Goldenberg I, Klein H, McNitt S, Polonsky B, Moss AJ, Kutyifa V; MADIT-CRT Executive Committee. Sex Differences in Long-Term Outcomes With Cardiac Resynchronization Therapy in Mild Heart Failure Patients With Left Bundle Branch Block. J Am Heart Assoc. 2015 Jun 29;4(7):e002013. doi: 10.1161/JAHA.115.002013. |
| 26038537 | Derived | Daimee UA, Moss AJ, Biton Y, Solomon SD, Klein HU, McNitt S, Polonsky B, Zareba W, Goldenberg I, Kutyifa V. Long-Term Outcomes With Cardiac Resynchronization Therapy in Patients With Mild Heart Failure With Moderate Renal Dysfunction. Circ Heart Fail. 2015 Jul;8(4):725-32. doi: 10.1161/CIRCHEARTFAILURE.115.002082. Epub 2015 Jun 2. |
| 24678999 | Derived | Goldenberg I, Kutyifa V, Klein HU, Cannom DS, Brown MW, Dan A, Daubert JP, Estes NA 3rd, Foster E, Greenberg H, Kautzner J, Klempfner R, Kuniss M, Merkely B, Pfeffer MA, Quesada A, Viskin S, McNitt S, Polonsky B, Ghanem A, Solomon SD, Wilber D, Zareba W, Moss AJ. Survival with cardiac-resynchronization therapy in mild heart failure. N Engl J Med. 2014 May 1;370(18):1694-701. doi: 10.1056/NEJMoa1401426. Epub 2014 Mar 30. |
| 24578164 | Derived | Skali H, Dwyer EM, Goldstein R, Haigney M, Krone R, Kukin M, Lichstein E, McNitt S, Moss AJ, Pfeffer MA, Solomon SD. Prognosis and response to therapy of first inpatient and outpatient heart failure event in a heart failure clinical trial: MADIT-CRT. Eur J Heart Fail. 2014 May;16(5):560-5. doi: 10.1002/ejhf.71. Epub 2014 Feb 27. |
| 23524528 | Derived | Campbell P, Takeuchi M, Bourgoun M, Shah A, Foster E, Brown MW, Goldenberg I, Huang DT, McNitt S, Hall WJ, Moss A, Pfeffer MA, Solomon SD; Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy (MADIT-CRT) Investigators. Right ventricular function, pulmonary pressure estimation, and clinical outcomes in cardiac resynchronization therapy. Circ Heart Fail. 2013 May;6(3):435-42. doi: 10.1161/CIRCHEARTFAILURE.112.000127. Epub 2013 Mar 22. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| New York Heart Association (NYHA) Class | Definitions of New York Heart Association Classification: NYHA Class I: Asymptomatic HF: no symptoms; NYHA Class II: Mild HF: symptomatic with moderate exertion | Number | participants |
|
| Left Ventricular Ejection Fraction | Mean | Standard Deviation | percentage |
|
| QRS duration | Mean | Standard Deviation | milliseconds |
|
| Conduction disorder | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| 58 |
| 149 |
| 9 |
| 149 |
| EG001 | MADIT-CRT CRT-D | MADIT-CRT CRT-D: Patients that were randomized to the the cardiac resynchronization therapy with defibrillation (CRT-D) device for the study. | 93 | 245 | 16 | 245 |
| Cancer | Blood and lymphatic system disorders |
|
| Normal ERI -Device Replacement | Surgical and medical procedures |
|
| Chest Pain - Ischemic | Cardiac disorders |
|
| Death | General disorders |
|
| Dizziness | General disorders |
|
| Dyspnea | General disorders |
|
| ERI - device component failure | Surgical and medical procedures |
|
| Endocrine | Endocrine disorders |
|
| Erosion | Skin and subcutaneous tissue disorders |
|
| Extracardiac Stimulation, Left Ventricular | Surgical and medical procedures |
|
| Fatigue | General disorders |
|
| Gastrointestinal | Gastrointestinal disorders |
|
| Genitourinary | Renal and urinary disorders |
|
| Head, Ears, Eyes, Nose and Throat | General disorders |
|
| Heart Failure Symptoms | Cardiac disorders |
|
| Hematological | Blood and lymphatic system disorders |
|
| Hematoma | Blood and lymphatic system disorders |
|
| Hypotention | Cardiac disorders |
|
| Infection (> 30 days post implant procedure) | Surgical and medical procedures |
|
| Integumentary | Skin and subcutaneous tissue disorders |
|
| Musculoskelatal | Musculoskeletal and connective tissue disorders |
|
| Myocardial Infarction | Cardiac disorders |
|
| Neurological | Nervous system disorders |
|
| Lead Related, Left Ventricular | Surgical and medical procedures |
|
| Patient Condition - Cardiovascular | Cardiac disorders |
|
| Patient Condition - noncardiovascular | General disorders |
|
| Device related, pulse generator | Surgical and medical procedures |
|
| Physical Trauma | General disorders |
|
| Hemorrhage, pocket | Surgical and medical procedures |
|
| Pulmonary | Respiratory, thoracic and mediastinal disorders |
|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders |
|
| Renal | Renal and urinary disorders |
|
| Supraventricular tachycardia | Cardiac disorders |
|
| Syncope | General disorders |
|
| Systemic Infection | Infections and infestations |
|
| Threshold Related, Left Ventricular | General disorders |
|
| Thromboembolic | Vascular disorders |
|
| Valvular Related | Cardiac disorders |
|
| Vascular Related | Vascular disorders |
|
| Ventricular Arrhythmia | Cardiac disorders |
|
| Cardiogenic Shock | Cardiac disorders |
|
| Hypertension | Cardiac disorders |
|
| Chest Pain - Non-Cardiac | General disorders |
|
| Premature Ventricular Contractions | Cardiac disorders |
|
The restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 30 days from the time submitted to the sponsor for review. The sponsor can request changes to the communication.