Trial Outcomes & Findings for Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy Post Approval Registry (NCT NCT01294449)
NCT ID: NCT01294449
Last Updated: 2014-12-04
Results Overview
Outcome measured for total population. Not broken down by indication received.
Recruitment status
COMPLETED
Target enrollment
394 participants
Primary outcome timeframe
5 years
Results posted on
2014-12-04
Participant Flow
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.
Participant milestones
| Measure |
MADIT-CRT ICD
MADIT-CRT ICD: Patients that were randomized to the the implantable cardioverter defibrillator (ICD) device for the study.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
156
|
252
|
|
Overall Study
Consent to Registry
|
149
|
245
|
|
Overall Study
COMPLETED
|
144
|
237
|
|
Overall Study
NOT COMPLETED
|
12
|
15
|
Reasons for withdrawal
| Measure |
MADIT-CRT ICD
MADIT-CRT ICD: Patients that were randomized to the the implantable cardioverter defibrillator (ICD) device for the study.
|
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.
|
|---|---|---|
|
Overall Study
Death
|
11
|
12
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
Baseline Characteristics
Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy Post Approval Registry
Baseline characteristics by cohort
| Measure |
MADIT-CRT ICD
n=156 Participants
MADIT-CRT ICD: Patients that were randomized to the the implantable cardioverter defibrillator (ICD) device for the study.
|
MADIT-CRT CRT-D
n=252 Participants
MADIT-CRT CRT-D: Patients that were randomized to the the cardiac resynchronization therapy with defibrillation (CRT-D) device for the study.
|
Total
n=408 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
77 Participants
n=5 Participants
|
126 Participants
n=7 Participants
|
203 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
79 Participants
n=5 Participants
|
126 Participants
n=7 Participants
|
205 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
120 Participants
n=5 Participants
|
174 Participants
n=7 Participants
|
294 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
156 participants
n=5 Participants
|
252 participants
n=7 Participants
|
408 participants
n=5 Participants
|
|
New York Heart Association (NYHA) Class
NYHA Class I - Ischemic
|
21 participants
n=5 Participants
|
36 participants
n=7 Participants
|
57 participants
n=5 Participants
|
|
New York Heart Association (NYHA) Class
NYHA Class II - Ischemic
|
54 participants
n=5 Participants
|
87 participants
n=7 Participants
|
141 participants
n=5 Participants
|
|
New York Heart Association (NYHA) Class
NYHA Class II - Non Ischemic
|
81 participants
n=5 Participants
|
129 participants
n=7 Participants
|
210 participants
n=5 Participants
|
|
Left Ventricular Ejection Fraction
|
24 percentage
STANDARD_DEVIATION 5 • n=5 Participants
|
24 percentage
STANDARD_DEVIATION 6 • n=7 Participants
|
24 percentage
STANDARD_DEVIATION 6 • n=5 Participants
|
|
QRS duration
|
158 milliseconds
STANDARD_DEVIATION 21 • n=5 Participants
|
159 milliseconds
STANDARD_DEVIATION 18 • n=7 Participants
|
159 milliseconds
STANDARD_DEVIATION 19 • n=5 Participants
|
|
Conduction disorder
Left Bundle Branch Block
|
110 participants
n=5 Participants
|
181 participants
n=7 Participants
|
291 participants
n=5 Participants
|
|
Conduction disorder
Right Bundle Brach Block
|
22 participants
n=5 Participants
|
31 participants
n=7 Participants
|
53 participants
n=5 Participants
|
|
Conduction disorder
Nonspecific Intraventricular Conduction
|
24 participants
n=5 Participants
|
40 participants
n=7 Participants
|
64 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 yearsOutcome measured for total population. Not broken down by indication received.
Outcome measures
| Measure |
MADIT-CRT ICD
n=156 Participants
MADIT-CRT ICD: Patients that were randomized to the the implantable cardioverter defibrillator (ICD) device for the study.
|
MADIT-CRT CRT-D
n=252 Participants
MADIT-CRT CRT-D: Patients that were randomized to the the cardiac resynchronization therapy with defibrillation (CRT-D) device for the study.
|
|---|---|---|
|
All-Cause Mortality
|
11 participants
|
12 participants
|
Adverse Events
MADIT-CRT ICD
Serious events: 58 serious events
Other events: 9 other events
Deaths: 0 deaths
MADIT-CRT CRT-D
Serious events: 93 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MADIT-CRT ICD
n=149 participants at risk
MADIT-CRT ICD: Patients that were randomized to the the implantable cardioverter defibrillator (ICD) device for the study.
|
MADIT-CRT CRT-D
n=245 participants at risk
MADIT-CRT CRT-D: Patients that were randomized to the the cardiac resynchronization therapy with defibrillation (CRT-D) device for the study.
|
|---|---|---|
|
Metabolism and nutrition disorders
Laboratory Values - Abnormal
|
0.67%
1/149 • Number of events 1
|
0.82%
2/245 • Number of events 2
|
|
Blood and lymphatic system disorders
Cancer
|
0.67%
1/149 • Number of events 1
|
3.3%
8/245 • Number of events 8
|
|
Surgical and medical procedures
Normal ERI -Device Replacement
|
2.7%
4/149 • Number of events 4
|
4.1%
10/245 • Number of events 10
|
|
Cardiac disorders
Chest Pain - Ischemic
|
0.00%
0/149
|
0.82%
2/245 • Number of events 2
|
|
General disorders
Death
|
0.67%
1/149 • Number of events 1
|
0.82%
2/245 • Number of events 2
|
|
General disorders
Dizziness
|
0.67%
1/149 • Number of events 2
|
0.82%
2/245 • Number of events 2
|
|
General disorders
Dyspnea
|
2.7%
4/149 • Number of events 4
|
0.41%
1/245 • Number of events 1
|
|
Surgical and medical procedures
ERI - device component failure
|
0.00%
0/149
|
0.41%
1/245 • Number of events 1
|
|
Endocrine disorders
Endocrine
|
0.67%
1/149 • Number of events 1
|
0.41%
1/245 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Erosion
|
0.67%
1/149 • Number of events 1
|
0.41%
1/245 • Number of events 1
|
|
Surgical and medical procedures
Extracardiac Stimulation, Left Ventricular
|
0.67%
1/149 • Number of events 1
|
0.41%
1/245 • Number of events 1
|
|
General disorders
Fatigue
|
0.00%
0/149
|
0.41%
1/245 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal
|
2.0%
3/149 • Number of events 3
|
2.9%
7/245 • Number of events 7
|
|
Renal and urinary disorders
Genitourinary
|
4.7%
7/149 • Number of events 7
|
0.82%
2/245 • Number of events 2
|
|
General disorders
Head, Ears, Eyes, Nose and Throat
|
0.00%
0/149
|
1.2%
3/245 • Number of events 3
|
|
Cardiac disorders
Heart Failure Symptoms
|
15.4%
23/149 • Number of events 43
|
10.6%
26/245 • Number of events 33
|
|
Blood and lymphatic system disorders
Hematological
|
0.00%
0/149
|
1.2%
3/245 • Number of events 3
|
|
Blood and lymphatic system disorders
Hematoma
|
0.00%
0/149
|
0.82%
2/245 • Number of events 2
|
|
Cardiac disorders
Hypotention
|
1.3%
2/149 • Number of events 2
|
0.82%
2/245 • Number of events 2
|
|
Surgical and medical procedures
Infection (> 30 days post implant procedure)
|
0.00%
0/149
|
0.82%
2/245 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Integumentary
|
0.67%
1/149 • Number of events 1
|
0.82%
2/245 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Musculoskelatal
|
6.0%
9/149 • Number of events 9
|
3.7%
9/245 • Number of events 9
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/149
|
1.6%
4/245 • Number of events 4
|
|
Nervous system disorders
Neurological
|
1.3%
2/149 • Number of events 3
|
1.2%
3/245 • Number of events 3
|
|
Surgical and medical procedures
Lead Related, Left Ventricular
|
0.67%
1/149 • Number of events 1
|
2.0%
5/245 • Number of events 5
|
|
Cardiac disorders
Patient Condition - Cardiovascular
|
1.3%
2/149 • Number of events 2
|
0.82%
2/245 • Number of events 2
|
|
General disorders
Patient Condition - noncardiovascular
|
1.3%
2/149 • Number of events 2
|
0.82%
2/245 • Number of events 2
|
|
Surgical and medical procedures
Device related, pulse generator
|
1.3%
2/149 • Number of events 2
|
0.41%
1/245 • Number of events 1
|
|
General disorders
Physical Trauma
|
0.00%
0/149
|
0.41%
1/245 • Number of events 1
|
|
Surgical and medical procedures
Hemorrhage, pocket
|
0.00%
0/149
|
0.82%
2/245 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
3.4%
5/149 • Number of events 5
|
1.6%
4/245 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/149
|
0.41%
1/245 • Number of events 1
|
|
Renal and urinary disorders
Renal
|
1.3%
2/149 • Number of events 2
|
1.6%
4/245 • Number of events 5
|
|
Cardiac disorders
Supraventricular tachycardia
|
2.7%
4/149 • Number of events 7
|
2.9%
7/245 • Number of events 7
|
|
General disorders
Syncope
|
0.67%
1/149 • Number of events 1
|
0.41%
1/245 • Number of events 1
|
|
Infections and infestations
Systemic Infection
|
1.3%
2/149 • Number of events 2
|
1.2%
3/245 • Number of events 3
|
|
General disorders
Threshold Related, Left Ventricular
|
0.00%
0/149
|
0.41%
1/245 • Number of events 1
|
|
Vascular disorders
Thromboembolic
|
0.67%
1/149 • Number of events 1
|
2.9%
7/245 • Number of events 9
|
|
Cardiac disorders
Valvular Related
|
0.00%
0/149
|
0.41%
1/245 • Number of events 1
|
|
Vascular disorders
Vascular Related
|
0.67%
1/149 • Number of events 1
|
1.2%
3/245 • Number of events 3
|
|
Cardiac disorders
Ventricular Arrhythmia
|
6.0%
9/149 • Number of events 10
|
4.1%
10/245 • Number of events 13
|
|
Cardiac disorders
Cardiogenic Shock
|
0.67%
1/149 • Number of events 1
|
0.00%
0/245
|
|
Cardiac disorders
Hypertension
|
0.67%
1/149 • Number of events 1
|
0.00%
0/245
|
|
General disorders
Chest Pain - Non-Cardiac
|
2.7%
4/149 • Number of events 7
|
1.2%
3/245 • Number of events 3
|
|
Cardiac disorders
Premature Ventricular Contractions
|
0.00%
0/149
|
0.41%
1/245 • Number of events 1
|
Other adverse events
| Measure |
MADIT-CRT ICD
n=149 participants at risk
MADIT-CRT ICD: Patients that were randomized to the the implantable cardioverter defibrillator (ICD) device for the study.
|
MADIT-CRT CRT-D
n=245 participants at risk
MADIT-CRT CRT-D: Patients that were randomized to the the cardiac resynchronization therapy with defibrillation (CRT-D) device for the study.
|
|---|---|---|
|
Cardiac disorders
Heart Failure Symptoms
|
6.0%
9/149 • Number of events 10
|
6.5%
16/245 • Number of events 21
|
Additional Information
Dr. Arthur Moss
University of Rochester Heart Research Follow-up Program
Phone: 585-275-5291
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER