Trial Outcomes & Findings for ACC - Atrial Contribution to CRT (NCT NCT00180323)
NCT ID: NCT00180323
Last Updated: 2021-02-11
Results Overview
Velocity time integral of the aortic flow correlates with cardiac output and is an accepted parameter for optimization of Cardiac Resynchronization Therapy (CRT).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
43 participants
Primary outcome timeframe
At implant (baseline), 3 months and 6 months Follow-up
Results posted on
2021-02-11
Participant Flow
Participant milestones
| Measure |
Group 1
|
|---|---|
|
Overall Study
STARTED
|
43
|
|
Overall Study
COMPLETED
|
43
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ACC - Atrial Contribution to CRT
Baseline characteristics by cohort
| Measure |
Group 1
n=43 Participants
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=5 Participants
|
|
Age, Continuous
|
61 years
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
43 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At implant (baseline), 3 months and 6 months Follow-upVelocity time integral of the aortic flow correlates with cardiac output and is an accepted parameter for optimization of Cardiac Resynchronization Therapy (CRT).
Outcome measures
| Measure |
Cardiac Resynchronization Therapy ICD (Renewal CRT)
n=43 Participants
Velocity time integral will be measured at implant (baseline), 3 months and 6 months Follow-up. Measurements will be taken at each timepoint at intrinsic heart rate and 10, 20 and 30 Bpm above intrinsic heart rate (paced rhythm)
|
|---|---|
|
Aortic Velocity Time Integral (VTI)
VTI at baseline intrinsic rhythm
|
22.4 cm
Standard Deviation 7.7
|
|
Aortic Velocity Time Integral (VTI)
VTI at baseline intrinsic rhythm + 10 Bpm
|
21.7 cm
Standard Deviation 7.7
|
|
Aortic Velocity Time Integral (VTI)
VTI at baseline intrinsic rhythm + 20 Bpm
|
19.4 cm
Standard Deviation 7.5
|
|
Aortic Velocity Time Integral (VTI)
VTI at baseline intrinsic rhythm + 30 Bpm
|
18.1 cm
Standard Deviation 7.1
|
|
Aortic Velocity Time Integral (VTI)
VTI at 3M Follow-up intrinsic rhythm
|
23.6 cm
Standard Deviation 9.0
|
|
Aortic Velocity Time Integral (VTI)
VTI at 3M Follow-up intrinsic rhythm + 10 Bpm
|
21.9 cm
Standard Deviation 9.0
|
|
Aortic Velocity Time Integral (VTI)
VTI at 3M Follow-up intrinsic rhythm + 20 Bpm
|
21.2 cm
Standard Deviation 8.1
|
|
Aortic Velocity Time Integral (VTI)
VTI at 3M Follow-up intrinsic rhythm + 30 Bpm
|
19.4 cm
Standard Deviation 8.3
|
|
Aortic Velocity Time Integral (VTI)
VTI at 6M Follow-up intrinsic rhythm
|
24.6 cm
Standard Deviation 8.4
|
|
Aortic Velocity Time Integral (VTI)
VTI at 6M Follow-up intrinsic rhythm + 10 Bpm
|
23.2 cm
Standard Deviation 7.5
|
|
Aortic Velocity Time Integral (VTI)
VTI at 6M Follow-up intrinsic rhythm + 20 Bpm
|
21.7 cm
Standard Deviation 7.0
|
|
Aortic Velocity Time Integral (VTI)
VTI at 6M Follow-up intrinsic rhythm + 30 Bpm
|
20.2 cm
Standard Deviation 7.2
|
PRIMARY outcome
Timeframe: Implant (baseline), 3 months and 6 months Follow-upOptimal AV-Delay will be measured at implant (baseline ), 3months and 6 months Follow-up for intrinsic heart rate, and 10, 20 and 30 Bpm above intrinsic heart rate.
Outcome measures
| Measure |
Cardiac Resynchronization Therapy ICD (Renewal CRT)
n=43 Participants
Velocity time integral will be measured at implant (baseline), 3 months and 6 months Follow-up. Measurements will be taken at each timepoint at intrinsic heart rate and 10, 20 and 30 Bpm above intrinsic heart rate (paced rhythm)
|
|---|---|
|
Optimal AV-Delay (AVD)
Optimal AVD at baseline intrinsic rhythm
|
115 ms
Standard Deviation 24
|
|
Optimal AV-Delay (AVD)
Optimal AVD at baseline intrinsic rhythm +10Bpm
|
119 ms
Standard Deviation 29
|
|
Optimal AV-Delay (AVD)
Optimal AVD at baseline intrinsic rhythm +20Bpm
|
123 ms
Standard Deviation 22
|
|
Optimal AV-Delay (AVD)
Optimal AVD at baseline intrinsic rhythm +30Bpm
|
127 ms
Standard Deviation 28
|
|
Optimal AV-Delay (AVD)
Optimal AVD at 3M intrinsic rhythm
|
117 ms
Standard Deviation 28
|
|
Optimal AV-Delay (AVD)
Optimal AVD at 3M intrinsic rhythm +10Bpm
|
117 ms
Standard Deviation 24
|
|
Optimal AV-Delay (AVD)
Optimal AVD at 3M intrinsic rhythm +20Bpm
|
127 ms
Standard Deviation 28
|
|
Optimal AV-Delay (AVD)
Optimal AVD at 3M intrinsic rhythm +3Bpm
|
119 ms
Standard Deviation 23
|
|
Optimal AV-Delay (AVD)
Optimal AVD at 6M intrinsic rhythm
|
115 ms
Standard Deviation 24
|
|
Optimal AV-Delay (AVD)
Optimal AVD at 6M intrinsic rhythm +10Bpm
|
132 ms
Standard Deviation 28
|
|
Optimal AV-Delay (AVD)
Optimal AVD at 6M intrinsic rhythm +20Bpm
|
130 ms
Standard Deviation 30
|
|
Optimal AV-Delay (AVD)
Optimal AVD at 6M intrinsic rhythm +30Bpm
|
130 ms
Standard Deviation 17
|
SECONDARY outcome
Timeframe: implant (baseline), 3 months and 6 months Follow-up6 Minute Walk Test was performed at implant (baseline), 3 months and 6 months follow-up Distance walked within 6 minutes is assessed in meter. This is a test that reflects daily life activities of elderly patients.
Outcome measures
| Measure |
Cardiac Resynchronization Therapy ICD (Renewal CRT)
n=43 Participants
Velocity time integral will be measured at implant (baseline), 3 months and 6 months Follow-up. Measurements will be taken at each timepoint at intrinsic heart rate and 10, 20 and 30 Bpm above intrinsic heart rate (paced rhythm)
|
|---|---|
|
6 Minute Walk Test
6 MWT at baseline
|
388 meter
Standard Error 88
|
|
6 Minute Walk Test
6 MWT at 3M Follow-up
|
470 meter
Standard Error 87
|
|
6 Minute Walk Test
6 MWT at 6M Follow-up
|
497 meter
Standard Error 83
|
SECONDARY outcome
Timeframe: implant (baseline), 3 Months, 6 MonthsLeft ventricular Ejection Fraction (LVEF) was measured before implant (baseline) and at 3 and 6 months Follow-up
Outcome measures
| Measure |
Cardiac Resynchronization Therapy ICD (Renewal CRT)
n=43 Participants
Velocity time integral will be measured at implant (baseline), 3 months and 6 months Follow-up. Measurements will be taken at each timepoint at intrinsic heart rate and 10, 20 and 30 Bpm above intrinsic heart rate (paced rhythm)
|
|---|---|
|
Left Ventricular Ejection Fraction (LVEF)
LVEF at baseline
|
21 % of cardiac volume
Standard Deviation 6
|
|
Left Ventricular Ejection Fraction (LVEF)
LVEF at 3M
|
24 % of cardiac volume
Standard Deviation 7
|
|
Left Ventricular Ejection Fraction (LVEF)
LVEF at 6M
|
24 % of cardiac volume
Standard Deviation 8
|
Adverse Events
Group 1
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
Dr. Jesper Hastrup Svendsen
Rigshospitalet, Copenhagen Unviversity Hospital, Denmark
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place