Trial Outcomes & Findings for Tachy Prediction Download Study (NCT NCT03402126)
NCT ID: NCT03402126
Last Updated: 2021-11-16
Results Overview
This was a data collection study collecting data when implanted device detected Ventricular Tachycardia/Ventricular Fibrillation.
Recruitment status
COMPLETED
Target enrollment
138 participants
Primary outcome timeframe
1 year
Results posted on
2021-11-16
Participant Flow
Participant milestones
| Measure |
TPD RAMWare Download
Subjects who qualify and consent to participate in the TPD study will have TPD RAMWare injected into their device to collect data.
TPD RAMWare: TPD RAMWare injected into enrolled subject's device.
|
|---|---|
|
Overall Study
STARTED
|
138
|
|
Overall Study
COMPLETED
|
76
|
|
Overall Study
NOT COMPLETED
|
62
|
Reasons for withdrawal
| Measure |
TPD RAMWare Download
Subjects who qualify and consent to participate in the TPD study will have TPD RAMWare injected into their device to collect data.
TPD RAMWare: TPD RAMWare injected into enrolled subject's device.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
|
Overall Study
Protocol Violation
|
10
|
|
Overall Study
Sponsor request/Study termination
|
29
|
|
Overall Study
Study product no longer in use
|
1
|
|
Overall Study
Technical problems
|
1
|
|
Overall Study
Withdrawal by Subject
|
6
|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
upgrade to Cardiac Resynchronization Therapy-Defibrillator/stage IV cancer
|
3
|
|
Overall Study
Death
|
4
|
Baseline Characteristics
Tachy Prediction Download Study
Baseline characteristics by cohort
| Measure |
TPD RAMWare Injected
n=128 Participants
Subjects who qualify and consent to participate in the TPD study will have TPD RAMWare injected into their device to collect data.
TPD RAMWare: TPD RAMWare injected into enrolled subject's device.
|
|---|---|
|
Age, Continuous
|
62 years
STANDARD_DEVIATION 13.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
104 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
126 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
81 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
Hong Kong
|
28 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
100 participants
n=5 Participants
|
|
Body Mass Index
|
29.8 kg/m^2
STANDARD_DEVIATION 6.9 • n=5 Participants
|
|
Weight
|
90.1 kg
STANDARD_DEVIATION 22.5 • n=5 Participants
|
|
Height
|
173.8 cm
STANDARD_DEVIATION 10.0 • n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearThis was a data collection study collecting data when implanted device detected Ventricular Tachycardia/Ventricular Fibrillation.
Outcome measures
| Measure |
TPD RAMWare Download
n=128 Participants
Subjects who qualify and consent to participate in the TPD study will have TPD RAMWare injected into their device to collect data.
TPD RAMWare: TPD RAMWare injected into enrolled subject's device.
|
|---|---|
|
Number of Participants With Device Detected Ventricular Tachycardia/Ventricular Fibrillation Episodes
Participants with device detected ventricular tachycardia/ventricular fibrillation episodes
|
31 Participants
|
|
Number of Participants With Device Detected Ventricular Tachycardia/Ventricular Fibrillation Episodes
Participants with no device detected ventricular tachycardia/ventricular fibrillation episode
|
97 Participants
|
Adverse Events
TPD RAMWare Download
Serious events: 0 serious events
Other events: 0 other events
Deaths: 4 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Participating Institution and PI agree that it will not independently publish, publicly disclose, present or discuss any results of or information pertaining to the Study until a multi-center publication is released; provided however, that if a multicenter publication is not released within one year after completion of the Study at all Study sites, Participating Institution and PI will have the right to publish the results of and information pertaining to their activities.
- Publication restrictions are in place
Restriction type: OTHER