Trial Outcomes & Findings for Comparison of VF Induction Techniques During Medtronic ICD Implant (VF) (ICD) (NCT NCT02027883)
NCT ID: NCT02027883
Last Updated: 2018-05-22
Results Overview
The primary endpoint is the successful induction of sustained ventricular fibrillation.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
2 hours
Results posted on
2018-05-22
Participant Flow
Participant milestones
| Measure |
Nominal Parameter
Nominal T shock setting
Nominal T shock setting: Nominal Parameter Set 1 Programming Values for EnTrust
|
Experimental Parameter
Educated T shock setting
Educated T shock setting: Experimental Parameter Set 2 Programming Values
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
50
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of VF Induction Techniques During Medtronic ICD Implant (VF) (ICD)
Baseline characteristics by cohort
| Measure |
Nominal Parameter
n=50 Participants
Nominal T shock setting
Nominal T shock setting: Nominal Parameter Set 1 Programming Values for EnTrust
|
Experimental Parameter
n=50 Participants
Educated T shock setting
Educated T shock setting: Experimental Parameter Set 2 Programming Values
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
23 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
55 Participants
n=206 Participants
|
|
Age, Continuous
|
61.82 years
STANDARD_DEVIATION 13.68403 • n=99 Participants
|
66.68 years
STANDARD_DEVIATION 10.51809 • n=107 Participants
|
64.25 years
STANDARD_DEVIATION 12.38554 • n=206 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
78 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
50 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
100 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
50 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
100 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=99 Participants
|
50 participants
n=107 Participants
|
100 participants
n=206 Participants
|
|
VF Induction amount of participants
|
50 participants
n=99 Participants
|
50 participants
n=107 Participants
|
100 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 2 hoursThe primary endpoint is the successful induction of sustained ventricular fibrillation.
Outcome measures
| Measure |
Nominal Parameter
n=50 Participants
Nominal T shock setting
Nominal T shock setting: Nominal Parameter Set 1 Programming Values for EnTrust
|
Experimental Parameter
n=50 Participants
Educated T shock setting
Educated T shock setting: Experimental Parameter Set 2 Programming Values
|
|---|---|---|
|
Sustained Ventricular Fibrillation
|
38 participants
|
35 participants
|
SECONDARY outcome
Timeframe: 2 hoursDetermine if any pre-implant patient demographics are factors impacting T-shock success according to parameter settings.
Outcome measures
| Measure |
Nominal Parameter
n=50 Participants
Nominal T shock setting
Nominal T shock setting: Nominal Parameter Set 1 Programming Values for EnTrust
|
Experimental Parameter
n=50 Participants
Educated T shock setting
Educated T shock setting: Experimental Parameter Set 2 Programming Values
|
|---|---|---|
|
Factors
Unsuccessful Female Participants
|
4 participants
|
3 participants
|
|
Factors
Successful Male Participants
|
30 participants
|
28 participants
|
|
Factors
Successful Female participants
|
8 participants
|
7 participants
|
|
Factors
Unsuccessful Male Participants
|
8 participants
|
12 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 hoursNumber of participants that were monitored for safety issues, including increased heart rate, blood pressure, decreased oximetry levels, and stable rhythm during the entire procedure.
Outcome measures
| Measure |
Nominal Parameter
n=50 Participants
Nominal T shock setting
Nominal T shock setting: Nominal Parameter Set 1 Programming Values for EnTrust
|
Experimental Parameter
n=50 Participants
Educated T shock setting
Educated T shock setting: Experimental Parameter Set 2 Programming Values
|
|---|---|---|
|
Safety Monitoring
|
50 participants
|
50 participants
|
Adverse Events
Nominal Parameter
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Experimental Parameter
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Terrie Walker, Director of Clinical Research
Wellmont CVA Heart Institute
Phone: 423-230-5643
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER