Trial Outcomes & Findings for SEEQ™ Performance Study (NCT NCT02484898)
NCT ID: NCT02484898
Last Updated: 2016-11-22
Results Overview
Recruitment status
COMPLETED
Target enrollment
200 participants
Primary outcome timeframe
120 Days
Results posted on
2016-11-22
Participant Flow
Participant milestones
| Measure |
SEEQ™ MCT/ECM System
SEEQ™ MCT/ECM monitoring for the detection of non-lethal cardiac arrhythmias.
|
|---|---|
|
Overall Study
STARTED
|
200
|
|
Overall Study
COMPLETED
|
182
|
|
Overall Study
NOT COMPLETED
|
18
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
SEEQ™ Performance Study
Baseline characteristics by cohort
| Measure |
SEEQ™ MCT/ECM System
n=200 Participants
SEEQ™ MCT/ECM monitoring for the detection of non-lethal cardiac arrhythmias.
|
|---|---|
|
Age, Continuous
|
73.6 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
109 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
91 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
200 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 120 DaysPopulation: Subjects prescribed the SEEQ™ MCT/ECM monitoring for the detection of non-lethal cardiac arrhythmias
Outcome measures
| Measure |
SEEQ™ MCT/ECM System
n=182 Participants
SEEQ™ MCT/ECM monitoring for the detection of non-lethal cardiac arrhythmias.
|
|---|---|
|
Diagnostic Yield of the SEEQ™ MCT/ECM System
|
85.7 percentage of subjects with CRA
Interval 79.8 to 90.5
|
Adverse Events
SEEQ™ MCT/ECM System
Serious events: 0 serious events
Other events: 63 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
SEEQ™ MCT/ECM System
n=182 participants at risk
SEEQ™ MCT/ECM monitoring for the detection of non-lethal cardiac arrhythmias.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Laceration
|
0.55%
1/182 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.1%
2/182 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Skin Irritation
|
33.0%
60/182 • Number of events 60
|
Additional Information
Medtronic SEEQ Performance Clinical Trial Leader
Medtronic CRHF
Phone: 1-800-328-2518
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60