Trial Outcomes & Findings for Comparison of AV Optimization Methods Used in Cardiac Resynchronization Therapy (CRT) (NCT NCT00677014)
NCT ID: NCT00677014
Last Updated: 2013-04-24
Results Overview
Change in square root of absolute left ventricular end systolic volume from baseline to 6 month follow up
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
1060 participants
Primary outcome timeframe
6 months
Results posted on
2013-04-24
Participant Flow
1060 patients were enrolled. 46 patients were not implanted with a CRT-D: screening failures (27), withdrawn by physician/sponsor (15) or withdrew consent (4). 34 implanted patients were not randomized: screening failures (13), withdrawn by physician/sponsor (14), withdrew consent (4), LTFU (2), death (1), not properly randomized (3)
Participant milestones
| Measure |
Fixed AV Delay
Patients programmed to a Fixed nominal AV delay of 120 ms with a sensed AV offset set to 0 and the LV offset set to 0
|
Echo Optimized AV Delay
Echo optimized AV delay (Iterative Method), LV offset is optional
|
Algorithm Optimized AV Delay
Algorithm optimized AV delay with sensed and paced AV delay recommendations and LV offset set to 0
|
|---|---|---|---|
|
Overall Study
COMPLETED
|
281
|
282
|
283
|
|
Overall Study
NOT COMPLETED
|
44
|
41
|
49
|
|
Overall Study
STARTED
|
325
|
323
|
332
|
Reasons for withdrawal
| Measure |
Fixed AV Delay
Patients programmed to a Fixed nominal AV delay of 120 ms with a sensed AV offset set to 0 and the LV offset set to 0
|
Echo Optimized AV Delay
Echo optimized AV delay (Iterative Method), LV offset is optional
|
Algorithm Optimized AV Delay
Algorithm optimized AV delay with sensed and paced AV delay recommendations and LV offset set to 0
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
20
|
12
|
24
|
|
Overall Study
Death
|
6
|
15
|
7
|
|
Overall Study
Unavailable or unreadable 6 month LVESV
|
18
|
14
|
18
|
Baseline Characteristics
Comparison of AV Optimization Methods Used in Cardiac Resynchronization Therapy (CRT)
Baseline characteristics by cohort
| Measure |
Fixed AV Delay
n=325 Participants
Patients programmed to a Fixed nominal AV delay of 120 ms with a sensed AV offset set to 0 and the LV offset set to 0
|
Echo Optimized AV Delay
n=323 Participants
Echo optimized AV delay (Iterative Method), LV offset is optional
|
Algorithm Optimized AV Delay
n=332 Participants
Algorithm optimized AV delay with sensed and paced AV delay recommendations and LV offset set to 0
|
Total
n=980 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
136 Participants
n=93 Participants
|
134 Participants
n=4 Participants
|
132 Participants
n=27 Participants
|
402 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
189 Participants
n=93 Participants
|
189 Participants
n=4 Participants
|
200 Participants
n=27 Participants
|
578 Participants
n=483 Participants
|
|
Age Continuous
|
66.4 years
STANDARD_DEVIATION 10.6 • n=93 Participants
|
65.8 years
STANDARD_DEVIATION 11.2 • n=4 Participants
|
66.1 years
STANDARD_DEVIATION 11.3 • n=27 Participants
|
66.1 years
STANDARD_DEVIATION 11.0 • n=483 Participants
|
|
Sex: Female, Male
Female
|
114 Participants
n=93 Participants
|
103 Participants
n=4 Participants
|
97 Participants
n=27 Participants
|
314 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
211 Participants
n=93 Participants
|
220 Participants
n=4 Participants
|
235 Participants
n=27 Participants
|
666 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
304 participants
n=93 Participants
|
301 participants
n=4 Participants
|
307 participants
n=27 Participants
|
912 participants
n=483 Participants
|
|
Region of Enrollment
Europe
|
21 participants
n=93 Participants
|
22 participants
n=4 Participants
|
25 participants
n=27 Participants
|
68 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Availability of baseline and 6 month echocardiograms with primary endpoint values (LVESV) among randomized patients
Change in square root of absolute left ventricular end systolic volume from baseline to 6 month follow up
Outcome measures
| Measure |
Fixed AV Delay
n=281 Participants
Patients programmed to a Fixed nominal AV delay of 120 ms with a sensed AV offset set to 0 and the LV offset set to 0
|
Echo Optimized AV Delay
n=282 Participants
Echo optimized AV delay (Iterative Method), LV offset is optional
|
Algorithm Optimized AV Delay
n=283 Participants
Algorithm optimized AV delay with sensed and paced AV delay recommendations and LV offset set to 0
|
|---|---|---|---|
|
Left Ventricular End-systolic Volume (LVESV)
|
-15 ml
Interval -41.0 to 6.0
|
-19 ml
Interval -45.0 to 6.0
|
-21 ml
Interval -45.0 to 6.0
|
SECONDARY outcome
Timeframe: ChronicOutcome measures
Outcome data not reported
Adverse Events
Fixed AV Delay
Serious events: 0 serious events
Other events: 145 other events
Deaths: 0 deaths
Echo Optimized AV Delay
Serious events: 0 serious events
Other events: 145 other events
Deaths: 0 deaths
Algorithm Optimized AV Delay
Serious events: 0 serious events
Other events: 144 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Fixed AV Delay
n=325 participants at risk
Patients programmed to a Fixed nominal AV delay of 120 ms with a sensed AV offset set to 0 and the LV offset set to 0
|
Echo Optimized AV Delay
n=323 participants at risk
Echo optimized AV delay (Iterative Method), LV offset is optional
|
Algorithm Optimized AV Delay
n=332 participants at risk
Algorithm optimized AV delay with sensed and paced AV delay recommendations and LV offset set to 0
|
|---|---|---|---|
|
Cardiac disorders
PG Related
|
1.8%
6/325 • Number of events 6 • Adverse event data were collected from randomization through the 6-month follow-up visit. Per trial design, serious adverse events were not collected in this trial.
Source vocabulary for AE coding was not used in this trial. Serious adverse events were not collected in this trial per trial design.
|
2.2%
7/323 • Number of events 9 • Adverse event data were collected from randomization through the 6-month follow-up visit. Per trial design, serious adverse events were not collected in this trial.
Source vocabulary for AE coding was not used in this trial. Serious adverse events were not collected in this trial per trial design.
|
1.8%
6/332 • Number of events 6 • Adverse event data were collected from randomization through the 6-month follow-up visit. Per trial design, serious adverse events were not collected in this trial.
Source vocabulary for AE coding was not used in this trial. Serious adverse events were not collected in this trial per trial design.
|
|
Cardiac disorders
RA Lead Related
|
4.3%
14/325 • Number of events 14 • Adverse event data were collected from randomization through the 6-month follow-up visit. Per trial design, serious adverse events were not collected in this trial.
Source vocabulary for AE coding was not used in this trial. Serious adverse events were not collected in this trial per trial design.
|
2.5%
8/323 • Number of events 8 • Adverse event data were collected from randomization through the 6-month follow-up visit. Per trial design, serious adverse events were not collected in this trial.
Source vocabulary for AE coding was not used in this trial. Serious adverse events were not collected in this trial per trial design.
|
2.1%
7/332 • Number of events 7 • Adverse event data were collected from randomization through the 6-month follow-up visit. Per trial design, serious adverse events were not collected in this trial.
Source vocabulary for AE coding was not used in this trial. Serious adverse events were not collected in this trial per trial design.
|
|
Cardiac disorders
RV Lead Related
|
2.8%
9/325 • Number of events 9 • Adverse event data were collected from randomization through the 6-month follow-up visit. Per trial design, serious adverse events were not collected in this trial.
Source vocabulary for AE coding was not used in this trial. Serious adverse events were not collected in this trial per trial design.
|
3.4%
11/323 • Number of events 13 • Adverse event data were collected from randomization through the 6-month follow-up visit. Per trial design, serious adverse events were not collected in this trial.
Source vocabulary for AE coding was not used in this trial. Serious adverse events were not collected in this trial per trial design.
|
2.1%
7/332 • Number of events 7 • Adverse event data were collected from randomization through the 6-month follow-up visit. Per trial design, serious adverse events were not collected in this trial.
Source vocabulary for AE coding was not used in this trial. Serious adverse events were not collected in this trial per trial design.
|
|
Cardiac disorders
Procedure Related
|
9.8%
32/325 • Number of events 36 • Adverse event data were collected from randomization through the 6-month follow-up visit. Per trial design, serious adverse events were not collected in this trial.
Source vocabulary for AE coding was not used in this trial. Serious adverse events were not collected in this trial per trial design.
|
5.9%
19/323 • Number of events 21 • Adverse event data were collected from randomization through the 6-month follow-up visit. Per trial design, serious adverse events were not collected in this trial.
Source vocabulary for AE coding was not used in this trial. Serious adverse events were not collected in this trial per trial design.
|
6.0%
20/332 • Number of events 23 • Adverse event data were collected from randomization through the 6-month follow-up visit. Per trial design, serious adverse events were not collected in this trial.
Source vocabulary for AE coding was not used in this trial. Serious adverse events were not collected in this trial per trial design.
|
|
Cardiac disorders
LV Lead Related
|
15.7%
51/325 • Number of events 60 • Adverse event data were collected from randomization through the 6-month follow-up visit. Per trial design, serious adverse events were not collected in this trial.
Source vocabulary for AE coding was not used in this trial. Serious adverse events were not collected in this trial per trial design.
|
14.9%
48/323 • Number of events 57 • Adverse event data were collected from randomization through the 6-month follow-up visit. Per trial design, serious adverse events were not collected in this trial.
Source vocabulary for AE coding was not used in this trial. Serious adverse events were not collected in this trial per trial design.
|
10.8%
36/332 • Number of events 39 • Adverse event data were collected from randomization through the 6-month follow-up visit. Per trial design, serious adverse events were not collected in this trial.
Source vocabulary for AE coding was not used in this trial. Serious adverse events were not collected in this trial per trial design.
|
|
Cardiac disorders
Cardiovascular Related
|
21.8%
71/325 • Number of events 108 • Adverse event data were collected from randomization through the 6-month follow-up visit. Per trial design, serious adverse events were not collected in this trial.
Source vocabulary for AE coding was not used in this trial. Serious adverse events were not collected in this trial per trial design.
|
23.8%
77/323 • Number of events 116 • Adverse event data were collected from randomization through the 6-month follow-up visit. Per trial design, serious adverse events were not collected in this trial.
Source vocabulary for AE coding was not used in this trial. Serious adverse events were not collected in this trial per trial design.
|
26.5%
88/332 • Number of events 132 • Adverse event data were collected from randomization through the 6-month follow-up visit. Per trial design, serious adverse events were not collected in this trial.
Source vocabulary for AE coding was not used in this trial. Serious adverse events were not collected in this trial per trial design.
|
|
Cardiac disorders
Death not related to any of the other Adverse Event categories
|
1.5%
5/325 • Number of events 5 • Adverse event data were collected from randomization through the 6-month follow-up visit. Per trial design, serious adverse events were not collected in this trial.
Source vocabulary for AE coding was not used in this trial. Serious adverse events were not collected in this trial per trial design.
|
2.2%
7/323 • Number of events 7 • Adverse event data were collected from randomization through the 6-month follow-up visit. Per trial design, serious adverse events were not collected in this trial.
Source vocabulary for AE coding was not used in this trial. Serious adverse events were not collected in this trial per trial design.
|
1.5%
5/332 • Number of events 5 • Adverse event data were collected from randomization through the 6-month follow-up visit. Per trial design, serious adverse events were not collected in this trial.
Source vocabulary for AE coding was not used in this trial. Serious adverse events were not collected in this trial per trial design.
|
|
General disorders
Non-Cardiovascular
|
2.2%
7/325 • Number of events 7 • Adverse event data were collected from randomization through the 6-month follow-up visit. Per trial design, serious adverse events were not collected in this trial.
Source vocabulary for AE coding was not used in this trial. Serious adverse events were not collected in this trial per trial design.
|
2.8%
9/323 • Number of events 9 • Adverse event data were collected from randomization through the 6-month follow-up visit. Per trial design, serious adverse events were not collected in this trial.
Source vocabulary for AE coding was not used in this trial. Serious adverse events were not collected in this trial per trial design.
|
3.6%
12/332 • Number of events 12 • Adverse event data were collected from randomization through the 6-month follow-up visit. Per trial design, serious adverse events were not collected in this trial.
Source vocabulary for AE coding was not used in this trial. Serious adverse events were not collected in this trial per trial design.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60