Trial Outcomes & Findings for ECG for Programming in CRT (NCT NCT03936608)
NCT ID: NCT03936608
Last Updated: 2020-12-03
Results Overview
LV end-systolic volume is a reliable surrogate for clinical outcomes in clinical heart failure trials.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
4 participants
Primary outcome timeframe
3-12 months
Results posted on
2020-12-03
Participant Flow
Participant milestones
| Measure |
Individualized RV-LV Pacing Offset
Programming individualized RV-LV pacing offset to optimize ECG: After CRT device implant, participants will undergo physiologic evaluations at various (up to 10 or more) RV-LV offset settings including ECGs. The RV-LV offset that optimizes the paced QRS morphology on ECG will be programmed.
|
No RV-LV Pacing Offset
Nominally programming CRT device without RV-LV offset: After CRT device implant, participants will undergo physiologic evaluations at various (up to 10 or more) RV-LV offset settings including ECGs. Nominal standard-of-care CRT programming with no RV-LV offset will be programmed.
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ECG for Programming in CRT
Baseline characteristics by cohort
| Measure |
Individualized RV-LV Pacing Offset
n=2 Participants
Programming individualized RV-LV pacing offset to optimize ECG: After CRT device implant, participants will undergo physiologic evaluations at various (up to 10 or more) RV-LV offset settings including ECGs. The RV-LV offset that optimizes the paced QRS morphology on ECG will be programmed.
|
No RV-LV Pacing Offset
n=2 Participants
Nominally programming CRT device without RV-LV offset: After CRT device implant, participants will undergo physiologic evaluations at various (up to 10 or more) RV-LV offset settings including ECGs. Nominal standard-of-care CRT programming with no RV-LV offset will be programmed.
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66 years
n=5 Participants
|
43 years
n=7 Participants
|
54.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Randomization Groups
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3-12 monthsPopulation: Study prematurely terminated, no data analysis was performed
LV end-systolic volume is a reliable surrogate for clinical outcomes in clinical heart failure trials.
Outcome measures
Outcome data not reported
Adverse Events
Individualized RV-LV Pacing Offset
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No RV-LV Pacing Offset
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place