Trial Outcomes & Findings for Specialized Pacing for Patients With Congenital Heart Disease (NCT NCT03361189)
NCT ID: NCT03361189
Last Updated: 2023-01-20
Results Overview
Heart rate in response to mental stress during each intervention; a math test was performed during autonomic testing
Recruitment status
TERMINATED
Study phase
PHASE2/PHASE3
Target enrollment
4 participants
Primary outcome timeframe
3 months after the start of each intervention, a total of 6 months
Results posted on
2023-01-20
Participant Flow
Participant milestones
| Measure |
CLS-On Followed by CLS-Off
Subjects in this arm will be programmed to CLS-on to received closed loop stimulation-based pacing for 3 months, followed by a standard rate response for 3 months.
Closed loop stimulation: Closed loop stimulation is a physiologic, rate-adaptive pacing algorithm.
Standard rate response: Standard rate response is an algorithm to increase heartrate based on movement
|
CLS-Off Followed by CLS-On
Subjects in this arm, will be placed in a standard rate response for 3 months, followed by CLS-on to received closed loop stimulation-based pacing for 3 months.
Closed loop stimulation: Closed loop stimulation is a physiologic, rate-adaptive pacing algorithm.
Standard rate response: Standard rate response is an algorithm to increase heartrate based on movement
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
|
Overall Study
Completed Test Period 1 Completed
|
1
|
1
|
|
Overall Study
Test Period 2 Begun
|
1
|
1
|
|
Overall Study
COMPLETED
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
CLS-On Followed by CLS-Off
Subjects in this arm will be programmed to CLS-on to received closed loop stimulation-based pacing for 3 months, followed by a standard rate response for 3 months.
Closed loop stimulation: Closed loop stimulation is a physiologic, rate-adaptive pacing algorithm.
Standard rate response: Standard rate response is an algorithm to increase heartrate based on movement
|
CLS-Off Followed by CLS-On
Subjects in this arm, will be placed in a standard rate response for 3 months, followed by CLS-on to received closed loop stimulation-based pacing for 3 months.
Closed loop stimulation: Closed loop stimulation is a physiologic, rate-adaptive pacing algorithm.
Standard rate response: Standard rate response is an algorithm to increase heartrate based on movement
|
|---|---|---|
|
Overall Study
Received heart transplant
|
1
|
0
|
|
Overall Study
Pacemake replacement
|
0
|
1
|
Baseline Characteristics
Specialized Pacing for Patients With Congenital Heart Disease
Baseline characteristics by cohort
| Measure |
CLS-On Followed by CLS-Off
n=2 Participants
Subjects in this arm will be programmed to CLS-on to received closed loop stimulation-based pacing for 3 months, followed by a standard rate response for 3 months.
Closed loop stimulation: Closed loop stimulation is a physiologic, rate-adaptive pacing algorithm.
Standard rate response: Standard rate response is an algorithm to increase heartrate based on movement
|
CLS-Off Followed by CLS-On
n=2 Participants
Subjects in this arm, will be placed in a standard rate response for 3 months, followed by CLS-on to received closed loop stimulation-based pacing for 3 months.
Closed loop stimulation: Closed loop stimulation is a physiologic, rate-adaptive pacing algorithm.
Standard rate response: Standard rate response is an algorithm to increase heartrate based on movement
|
Total
n=4 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
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 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
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 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
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 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
|
2 participants
n=99 Participants
|
2 participants
n=107 Participants
|
4 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 3 months after the start of each intervention, a total of 6 monthsPopulation: One participant completed autonomic testing
Heart rate in response to mental stress during each intervention; a math test was performed during autonomic testing
Outcome measures
| Measure |
CLS-On
n=1 Participants
Subjects in this arm will be programmed to CLS-on to received closed loop stimulation-based pacing for 3 months Closed loop stimulation: Closed loop stimulation is a physiologic, rate-adaptive pacing algorithm.
|
CLS-Off (Standard Rate Response)
n=1 Participants
Subjects in this arm will be programmed to Standard rate response for 3 months. Standard rate response: Standard rate response is an algorithm to increase heartrate based on movement
|
|---|---|---|
|
Number of Participants With Blunted or Unchanged Effect of Mental Stress on Heart Rate
Heart rate blunted
|
1 Participants
|
0 Participants
|
|
Number of Participants With Blunted or Unchanged Effect of Mental Stress on Heart Rate
Heart rate unchanged
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 3 months after the start of each intervention, a total of 6 monthsPopulation: Participants with interpretable Holter monitor data under both interventions
Average heart rate as measured by Holter monitor for 48 hours during each intervention
Outcome measures
| Measure |
CLS-On
n=2 Participants
Subjects in this arm will be programmed to CLS-on to received closed loop stimulation-based pacing for 3 months Closed loop stimulation: Closed loop stimulation is a physiologic, rate-adaptive pacing algorithm.
|
CLS-Off (Standard Rate Response)
n=2 Participants
Subjects in this arm will be programmed to Standard rate response for 3 months. Standard rate response: Standard rate response is an algorithm to increase heartrate based on movement
|
|---|---|---|
|
Heart Rate Response During a 48-hour Assessment Period
|
74 beats per minute
Interval 59.0 to 135.0
|
73 beats per minute
Interval 40.0 to 144.0
|
SECONDARY outcome
Timeframe: 3 months after the start of each intervention, a total of 6 monthsPopulation: Only one participant completed stress tests, due to COVID restrictions, equipment and staffing issues
Oxygen uptake as determined by cardiopulmonary gas exchange during a stress test under 4 conditions: Sitting/standing 60 seconds Kettlebell walking 110 seconds Stairs 176 seconds Sweeping 62 seconds
Outcome measures
| Measure |
CLS-On
n=1 Participants
Subjects in this arm will be programmed to CLS-on to received closed loop stimulation-based pacing for 3 months Closed loop stimulation: Closed loop stimulation is a physiologic, rate-adaptive pacing algorithm.
|
CLS-Off (Standard Rate Response)
n=1 Participants
Subjects in this arm will be programmed to Standard rate response for 3 months. Standard rate response: Standard rate response is an algorithm to increase heartrate based on movement
|
|---|---|---|
|
Average Oxygen Consumption During Each Intervention
Sweeping
|
0.78 liters/minute
|
0.80 liters/minute
|
|
Average Oxygen Consumption During Each Intervention
Sitting/Standing
|
1.01 liters/minute
|
1.04 liters/minute
|
|
Average Oxygen Consumption During Each Intervention
Kettlebell walking
|
1.02 liters/minute
|
1.10 liters/minute
|
|
Average Oxygen Consumption During Each Intervention
Stairs
|
0.82 liters/minute
|
0.87 liters/minute
|
SECONDARY outcome
Timeframe: 3 months after the start of each intervention, a total of 6 monthsPopulation: Two participants completed SF36 assessments
Quality of life as assessed by SF-36 questionnaire following each period of intervetion. SF- 36 investigates the standard of quality of life through a general health assessment and not specific to a particular disease, age or treatment group. It is a 36-item questionnaire measuring 8 domains \[physical functioning, role limitations due to physical health (role physical), bodily pain, general health, energy, social functioning, role limitations due to emotional health (role emotional), and emotional wellbeing\]. Each domain score ranges from 0 (worst) to 100 (best), with higher scores reflecting better health-related functional status.
Outcome measures
| Measure |
CLS-On
n=2 Participants
Subjects in this arm will be programmed to CLS-on to received closed loop stimulation-based pacing for 3 months Closed loop stimulation: Closed loop stimulation is a physiologic, rate-adaptive pacing algorithm.
|
CLS-Off (Standard Rate Response)
n=2 Participants
Subjects in this arm will be programmed to Standard rate response for 3 months. Standard rate response: Standard rate response is an algorithm to increase heartrate based on movement
|
|---|---|---|
|
Quality of Life as Assessed by SF-36
Physical functioning
|
95 score on a scale
Interval 95.0 to 95.0
|
92.5 score on a scale
Interval 90.0 to 95.0
|
|
Quality of Life as Assessed by SF-36
Role physical
|
100 score on a scale
Interval 100.0 to 100.0
|
100 score on a scale
Interval 100.0 to 100.0
|
|
Quality of Life as Assessed by SF-36
Bodily pain
|
90 score on a scale
Interval 90.0 to 90.0
|
85 score on a scale
Interval 80.0 to 90.0
|
|
Quality of Life as Assessed by SF-36
General health
|
67.5 score on a scale
Interval 65.0 to 70.0
|
42.5 score on a scale
Interval 35.0 to 50.0
|
|
Quality of Life as Assessed by SF-36
Energy/vitality
|
47.5 score on a scale
Interval 35.0 to 60.0
|
47.5 score on a scale
Interval 40.0 to 55.0
|
|
Quality of Life as Assessed by SF-36
Social Function
|
100 score on a scale
Interval 100.0 to 100.0
|
100 score on a scale
Interval 100.0 to 100.0
|
|
Quality of Life as Assessed by SF-36
Role emotional
|
100 score on a scale
Interval 100.0 to 100.0
|
100 score on a scale
Interval 100.0 to 100.0
|
|
Quality of Life as Assessed by SF-36
Emotional wellbeing
|
86 score on a scale
Interval 84.0 to 88.0
|
84 score on a scale
Interval 84.0 to 84.0
|
Adverse Events
CLS-On
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CLS-Off
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