Trial Outcomes & Findings for Adaptive CRT Effect on Electrical Dyssynchrony (NCT NCT02543281)
NCT ID: NCT02543281
Last Updated: 2025-03-20
Results Overview
LV and RV activation time values were measured on reconstructed epicardial activation maps at baseline and 6 months post-CRT. Positive VEU indicated LV uncoupling (delay) from the RV, whereas negative VEU indicated RV uncoupling (delay) from the LV. Difference in difference (change in VEU from baseline to 6 months post-CRT) is reported as the primary outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
32 participants
Primary outcome timeframe
baseline and 6 months after device implantation
Results posted on
2025-03-20
Participant Flow
Participant milestones
| Measure |
aCRT Off
The adaptive CRT algorithm will be turned off for the CRT device implanted in the patients in this arm.
Conventional Cardiac Resynchronization Therapy: CRT without the adaptive algorithm works by giving stimulation to both sides of the heart.
|
aCRT On
The adaptive CRT algorithm will be turned on for the CRT device implanted in the patients in this arm.
Adaptive cardiac resynchronization therapy: The adaptive cardiac resynchronization therapy (aCRT) algorithm works by sometimes giving stimulation to only the left side of the heart, rather than to both sides, depending on how it senses the heart is functioning.
|
Registry
Participants who were not eligible for the randomization because of the implantation of the device that was not capable of delivering aCRT. The team of clinical care providers made such a clinical decision acting in the best interests of a patient.
|
|---|---|---|---|
|
Overall Study
STARTED
|
15
|
12
|
5
|
|
Overall Study
COMPLETED
|
15
|
12
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
aCRT Off
The adaptive CRT algorithm will be turned off for the CRT device implanted in the patients in this arm.
Conventional Cardiac Resynchronization Therapy: CRT without the adaptive algorithm works by giving stimulation to both sides of the heart.
|
aCRT On
The adaptive CRT algorithm will be turned on for the CRT device implanted in the patients in this arm.
Adaptive cardiac resynchronization therapy: The adaptive cardiac resynchronization therapy (aCRT) algorithm works by sometimes giving stimulation to only the left side of the heart, rather than to both sides, depending on how it senses the heart is functioning.
|
Registry
Participants who were not eligible for the randomization because of the implantation of the device that was not capable of delivering aCRT. The team of clinical care providers made such a clinical decision acting in the best interests of a patient.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
Baseline Characteristics
Adaptive CRT Effect on Electrical Dyssynchrony
Baseline characteristics by cohort
| Measure |
aCRT Off
n=15 Participants
The adaptive CRT algorithm turned off for the CRT device implanted in the patients in this arm.
Conventional Cardiac Resynchronization Therapy: CRT without the adaptive algorithm works by giving stimulation to both sides of the heart.
|
aCRT On
n=12 Participants
The adaptive CRT algorithm turned on for the CRT device implanted in the patients in this arm.
Adaptive cardiac resynchronization therapy: The adaptive cardiac resynchronization therapy (aCRT) algorithm works by sometimes giving stimulation to only the left side of the heart, rather than to both sides, depending on how it senses the heart is functioning.
|
Registry
n=5 Participants
Participants who were not eligible for the randomization because of the implantation of the device that was not capable of delivering aCRT. The team of clinical care providers made such a clinical decision acting in the best interests of a patient.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
65.3 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
62.2 years
STANDARD_DEVIATION 10.3 • n=7 Participants
|
67.3 years
STANDARD_DEVIATION 13.6 • n=5 Participants
|
64.4 years
STANDARD_DEVIATION 11.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race and Ethnicity · Non-Hispanic White
|
15 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race and Ethnicity · Non-White or Hispanic
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
12 participants
n=7 Participants
|
5 participants
n=5 Participants
|
32 participants
n=4 Participants
|
|
Left Ventricular Ejection Fraction
|
26 Percentage of Left Ventricular EF
STANDARD_DEVIATION 8.6 • n=5 Participants
|
29.7 Percentage of Left Ventricular EF
STANDARD_DEVIATION 7.5 • n=7 Participants
|
32.3 Percentage of Left Ventricular EF
STANDARD_DEVIATION 6.4 • n=5 Participants
|
28.4 Percentage of Left Ventricular EF
STANDARD_DEVIATION 8.0 • n=4 Participants
|
|
Ischemic cardiomyopathy
Ischemic cardiomyopathy
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Ischemic cardiomyopathy
Non-ischemic cardiomyopathy
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
QRS duration
|
151.3 ms
STANDARD_DEVIATION 24.3 • n=5 Participants
|
160.6 ms
STANDARD_DEVIATION 19.0 • n=7 Participants
|
153.1 ms
STANDARD_DEVIATION 20.9 • n=5 Participants
|
155.1 ms
STANDARD_DEVIATION 20.9 • n=4 Participants
|
|
Left Bundle Branch Block
Left Bundle Branch Block (strict criteria)
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Left Bundle Branch Block
Non - Left Bundle Branch Block
|
14 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
NYHA Class
NYHA Class II (less severe)
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
NYHA Class
NYHA Class III (more severe)
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: baseline and 6 months after device implantationLV and RV activation time values were measured on reconstructed epicardial activation maps at baseline and 6 months post-CRT. Positive VEU indicated LV uncoupling (delay) from the RV, whereas negative VEU indicated RV uncoupling (delay) from the LV. Difference in difference (change in VEU from baseline to 6 months post-CRT) is reported as the primary outcome.
Outcome measures
| Measure |
aCRT Off
n=15 Participants
The adaptive CRT algorithm turned off for the CRT device implanted in the patients in this arm.
Conventional Cardiac Resynchronization Therapy: CRT without the adaptive algorithm works by giving stimulation to both sides of the heart.
|
aCRT On
n=12 Participants
The adaptive CRT algorithm turned on for the CRT device implanted in the patients in this arm.
Adaptive cardiac resynchronization therapy: The adaptive cardiac resynchronization therapy (aCRT) algorithm works by sometimes giving stimulation to only the left side of the heart, rather than to both sides, depending on how it senses the heart is functioning.
|
Registry
n=4 Participants
Participants who were not eligible for the randomization because of the implantation of the device that was not capable of delivering aCRT. The team of clinical care providers made such a clinical decision acting in the best interests of a patient.
|
|---|---|---|---|
|
Change in Ventricular Electrical Uncoupling (VEU), Calculated as the Difference in Difference Between the Mean Left Ventricular (LV) and Right Ventricular (RV) Activation Times.
|
21.4 ms
Interval -30.0 to 49.9
|
18.9 ms
Interval 4.3 to 29.2
|
6.0 ms
Interval -8.0 to 11.6
|
SECONDARY outcome
Timeframe: baseline and 6 months after device implantationChange in 6-minute walk distance 6 months post CRT as compared to baseline
Outcome measures
| Measure |
aCRT Off
n=15 Participants
The adaptive CRT algorithm turned off for the CRT device implanted in the patients in this arm.
Conventional Cardiac Resynchronization Therapy: CRT without the adaptive algorithm works by giving stimulation to both sides of the heart.
|
aCRT On
n=12 Participants
The adaptive CRT algorithm turned on for the CRT device implanted in the patients in this arm.
Adaptive cardiac resynchronization therapy: The adaptive cardiac resynchronization therapy (aCRT) algorithm works by sometimes giving stimulation to only the left side of the heart, rather than to both sides, depending on how it senses the heart is functioning.
|
Registry
n=4 Participants
Participants who were not eligible for the randomization because of the implantation of the device that was not capable of delivering aCRT. The team of clinical care providers made such a clinical decision acting in the best interests of a patient.
|
|---|---|---|---|
|
Change in 6-minute Walk Distance 6 Months Post CRT
|
18 m
Interval -12.0 to 41.0
|
-19 m
Interval -76.0 to 57.0
|
141 m
Interval 66.0 to 215.0
|
SECONDARY outcome
Timeframe: baseline and 6 months after device implantationChange in Minnesota Living with Heart Failure Questionnaire (MLHFQ) total score 6 months post-CRT as compared to baseline. The total MLHFQ score range from 0 (zero; the best health) to 105 (the worst health). Higher MLHFQ values represent worse health. Negative values of the change in total MLHFQ score mean the total MLHFQ score decreased six months after device implantation compared to baseline (improvement).
Outcome measures
| Measure |
aCRT Off
n=15 Participants
The adaptive CRT algorithm turned off for the CRT device implanted in the patients in this arm.
Conventional Cardiac Resynchronization Therapy: CRT without the adaptive algorithm works by giving stimulation to both sides of the heart.
|
aCRT On
n=12 Participants
The adaptive CRT algorithm turned on for the CRT device implanted in the patients in this arm.
Adaptive cardiac resynchronization therapy: The adaptive cardiac resynchronization therapy (aCRT) algorithm works by sometimes giving stimulation to only the left side of the heart, rather than to both sides, depending on how it senses the heart is functioning.
|
Registry
n=4 Participants
Participants who were not eligible for the randomization because of the implantation of the device that was not capable of delivering aCRT. The team of clinical care providers made such a clinical decision acting in the best interests of a patient.
|
|---|---|---|---|
|
Change in MLHFQ Total Score
|
-20 units on a scale
Interval -30.0 to -4.0
|
-7 units on a scale
Interval -15.0 to 0.5
|
-28 units on a scale
Interval -43.0 to -9.0
|
Adverse Events
aCRT Off
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
aCRT On
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Registry
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
Larisa Tereshchenko
Cleveland Clinic, Lerner Research Institute
Phone: 2164442445
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place