Trial Outcomes & Findings for DEfibrillators To REduce Risk by MagnetIc ResoNance Imaging Evaluation (NCT NCT00487279)
NCT ID: NCT00487279
Last Updated: 2019-02-05
Results Overview
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
81 participants
Primary outcome timeframe
Total survival will be evaluated 2 years after the last patient is randomized.
Results posted on
2019-02-05
Participant Flow
Participant milestones
| Measure |
ICD Group
ICD (Implantable Cardioverter Defibrillator)in combination with medical therapy
|
Control Group
Medical therapy alone
|
|---|---|---|
|
Overall Study
STARTED
|
44
|
37
|
|
Overall Study
COMPLETED
|
43
|
35
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
ICD Group
ICD (Implantable Cardioverter Defibrillator)in combination with medical therapy
|
Control Group
Medical therapy alone
|
|---|---|---|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
DEfibrillators To REduce Risk by MagnetIc ResoNance Imaging Evaluation
Baseline characteristics by cohort
| Measure |
ICD Group
n=44 Participants
ICD (Implantable Cardioverter Defibrillator)in combination with medical therapy
|
Control Group
n=37 Participants
Medical therapy alone
|
Total
n=81 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=113 Participants
|
16 Participants
n=163 Participants
|
40 Participants
n=160 Participants
|
|
Age, Categorical
>=65 years
|
20 Participants
n=113 Participants
|
21 Participants
n=163 Participants
|
41 Participants
n=160 Participants
|
|
Age, Continuous
|
62 years
STANDARD_DEVIATION 11 • n=113 Participants
|
65 years
STANDARD_DEVIATION 12 • n=163 Participants
|
63 years
STANDARD_DEVIATION 12 • n=160 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=113 Participants
|
5 Participants
n=163 Participants
|
16 Participants
n=160 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=113 Participants
|
32 Participants
n=163 Participants
|
65 Participants
n=160 Participants
|
|
Region of Enrollment
United States
|
44 participants
n=113 Participants
|
37 participants
n=163 Participants
|
81 participants
n=160 Participants
|
PRIMARY outcome
Timeframe: Total survival will be evaluated 2 years after the last patient is randomized.Population: Intent to Treat
Outcome measures
| Measure |
ICD Group
n=44 Participants
ICD (Implantable Cardioverter Defibrillator)in combination with medical therapy
|
Control Group
n=37 Participants
Medical therapy alone
|
|---|---|---|
|
All-cause Mortality
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Total survival will be evaluated 2 years after the last patient is randomized.Arrhythmic mortality was reported as the number of randomized patients who died due to arrhythmic death. Arrhythmic death was defined as death due to arrhythmia or sudden death.
Outcome measures
| Measure |
ICD Group
n=44 Participants
ICD (Implantable Cardioverter Defibrillator)in combination with medical therapy
|
Control Group
n=37 Participants
Medical therapy alone
|
|---|---|---|
|
Arrhythmic Mortality
|
0 participants
|
0 participants
|
Adverse Events
ICD Group
Serious events: 3 serious events
Other events: 2 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ICD Group
n=44 participants at risk
ICD (Implantable Cardioverter Defibrillator)in combination with medical therapy
|
Control Group
Medical therapy alone
|
|---|---|---|
|
Injury, poisoning and procedural complications
Lead Dislodgment or Migration
|
100.0%
3/3 • Number of events 3
Serious adverse events were defined as those related to the device or its implantation procedure. Therefore, the control group was not at risk for a serious adverse event. Other adverse events were defined as non-serious adverse events related to the ICD or its implant procedure. The control group was not at risk for an other adverse event.
|
—
0/0
Serious adverse events were defined as those related to the device or its implantation procedure. Therefore, the control group was not at risk for a serious adverse event. Other adverse events were defined as non-serious adverse events related to the ICD or its implant procedure. The control group was not at risk for an other adverse event.
|
Other adverse events
| Measure |
ICD Group
n=44 participants at risk
ICD (Implantable Cardioverter Defibrillator)in combination with medical therapy
|
Control Group
Medical therapy alone
|
|---|---|---|
|
Infections and infestations
Infection
|
100.0%
1/1 • Number of events 1
Serious adverse events were defined as those related to the device or its implantation procedure. Therefore, the control group was not at risk for a serious adverse event. Other adverse events were defined as non-serious adverse events related to the ICD or its implant procedure. The control group was not at risk for an other adverse event.
|
—
0/0
Serious adverse events were defined as those related to the device or its implantation procedure. Therefore, the control group was not at risk for a serious adverse event. Other adverse events were defined as non-serious adverse events related to the ICD or its implant procedure. The control group was not at risk for an other adverse event.
|
|
Injury, poisoning and procedural complications
Lead Dislodgment or Migration
|
100.0%
1/1 • Number of events 1
Serious adverse events were defined as those related to the device or its implantation procedure. Therefore, the control group was not at risk for a serious adverse event. Other adverse events were defined as non-serious adverse events related to the ICD or its implant procedure. The control group was not at risk for an other adverse event.
|
—
0/0
Serious adverse events were defined as those related to the device or its implantation procedure. Therefore, the control group was not at risk for a serious adverse event. Other adverse events were defined as non-serious adverse events related to the ICD or its implant procedure. The control group was not at risk for an other adverse event.
|
Additional Information
Heidi Hinrichs/Sr. Director, Clinical Operations
St. Jude Medical CRMD
Phone: (818) 493-3297
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee All publications must be reviewed by the Sponsor, Executive Sterring Committe and the Publications Committee at least 30 days prior to submittal. In the event that no multi-center study publication occurs within 12 months of study completion, investigators may publish the restuls of the study data from those subjects enrolled in a study at the Institution provided the Sponsor, Executive Steering Committee and Publicaiton Committee review at least 30 days prior to submittal.
- Publication restrictions are in place
Restriction type: OTHER