Trial Outcomes & Findings for QuickOpt Chronic Study (NCT NCT01172067)
NCT ID: NCT01172067
Last Updated: 2019-10-08
Results Overview
The primary outcome is the percent change in LVESV at 12 months compared to baseline. This outcome measure is assessed through evaluation of echocardiograms at both baseline and 12 months, with a decrease in the percent change in LVESV at 12 months indicating clinical improvement. The percent change in patients with devices optimized with QuickOpt is compared with that of patients with devices optimized using standard echocardiography techniques to determine if one method of optimization results in a greater change in LVESV.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
400 participants
Primary outcome timeframe
Baseline and12 months
Results posted on
2019-10-08
Participant Flow
Participant milestones
| Measure |
Quickopt Group
the QuickOpt Group patients will be optimized by QuickOpt(IEGM);
Cardiac Resynchronization Therapy: Patients will be optimized using QuickOpt (IEGM) algorithm installed on the Merlin device programmer within 2 weeks and 3 and 6 months after device implantation.
|
Echocardiography Group
the Echo Group patients will be optimized by Echo.
Optimization using echocardiography: Optimization of the AV/PV and VV delays using echocardiography
|
|---|---|---|
|
Overall Study
STARTED
|
200
|
200
|
|
Overall Study
COMPLETED
|
153
|
163
|
|
Overall Study
NOT COMPLETED
|
47
|
37
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
QuickOpt Chronic Study
Baseline characteristics by cohort
| Measure |
QuickOpt Group
n=198 Participants
Patients will be optimized using QuickOpt (IEGM) algorithm installed on the Merlin device programmer within 2 weeks and 3 and 6 months after device implantation.
|
Echocardiography Group
n=194 Participants
Optimization using echocardiography: Optimization of the AV/PV and VV delays using echocardiography
|
Total
n=392 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
|
|
Age, Categorical
Between 18 and 65 years
|
121 Participants
n=93 Participants
|
133 Participants
n=4 Participants
|
254 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
77 Participants
n=93 Participants
|
61 Participants
n=4 Participants
|
138 Participants
n=27 Participants
|
|
Age, Continuous
|
61.38 years
STANDARD_DEVIATION 11.77 • n=93 Participants
|
59.21 years
STANDARD_DEVIATION 11.36 • n=4 Participants
|
60.17 years
STANDARD_DEVIATION 11.62 • n=27 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=93 Participants
|
54 Participants
n=4 Participants
|
103 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
149 Participants
n=93 Participants
|
140 Participants
n=4 Participants
|
289 Participants
n=27 Participants
|
|
Region of Enrollment
China
|
198 participants
n=93 Participants
|
194 participants
n=4 Participants
|
392 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline and12 monthsPopulation: A total of 108 patients in the QuickOpt group and 118 patients in the Echocardiography group had LVESV measurements at both baseline and 12 months to allow comparison of the percent change in LVESV.
The primary outcome is the percent change in LVESV at 12 months compared to baseline. This outcome measure is assessed through evaluation of echocardiograms at both baseline and 12 months, with a decrease in the percent change in LVESV at 12 months indicating clinical improvement. The percent change in patients with devices optimized with QuickOpt is compared with that of patients with devices optimized using standard echocardiography techniques to determine if one method of optimization results in a greater change in LVESV.
Outcome measures
| Measure |
QuickOpt Group
n=108 Participants
Patients will be optimized using QuickOpt (IEGM) algorithm installed on the Merlin device programmer within 2 weeks and 3 and 6 months after device implantation.
|
Echocardiography Group
n=118 Participants
Optimization using echocardiography: Optimization of the AV/PV and VV delays using echocardiography
|
|---|---|---|
|
Percent Change in Left Ventricular End Systolic Volume (LVESV) at 12 Months Compared to Baseline
|
-24.69 Percent change in LVESV
Standard Deviation 33.86
|
-25.13 Percent change in LVESV
Standard Deviation 36.06
|
Adverse Events
Quickopt Group
Serious events: 28 serious events
Other events: 6 other events
Deaths: 23 deaths
Echocardiography Group
Serious events: 19 serious events
Other events: 6 other events
Deaths: 15 deaths
Serious adverse events
| Measure |
Quickopt Group
n=198 participants at risk
the QuickOpt Group patients will be optimized by QuickOpt(IEGM);
Cardiac Resynchronization Therapy: Patients will be optimized using QuickOpt (IEGM) algorithm installed on the Merlin device programmer within 2 weeks and 3 and 6 months after device implantation.
|
Echocardiography Group
n=194 participants at risk
the Echo Group patients will be optimized by Echo.
Optimization using echocardiography: Optimization of the AV/PV and VV delays using echocardiography
|
|---|---|---|
|
Cardiac disorders
Death
|
7.6%
15/198 • Number of events 15 • 1 year
|
6.7%
13/194 • Number of events 13 • 1 year
|
|
Cardiac disorders
Hopitalization
|
1.5%
3/198 • Number of events 3 • 1 year
|
0.52%
1/194 • Number of events 1 • 1 year
|
|
Cardiac disorders
Heart Failure Deterioration; Death
|
1.0%
2/198 • Number of events 2 • 1 year
|
0.00%
0/194 • 1 year
|
|
Cardiac disorders
Cardiopulmonary arrest, death
|
1.0%
2/198 • Number of events 2 • 1 year
|
0.00%
0/194 • 1 year
|
|
Cardiac disorders
Junctional rhythm, hypotension
|
0.51%
1/198 • Number of events 1 • 1 year
|
0.00%
0/194 • 1 year
|
|
Cardiac disorders
Heart failure deterioration, hospitalization
|
0.00%
0/198 • 1 year
|
0.52%
1/194 • Number of events 1 • 1 year
|
|
Cardiac disorders
Heart failure deterioration, elevated left ventricular pacing threshold
|
0.51%
1/198 • Number of events 1 • 1 year
|
0.00%
0/194 • 1 year
|
|
Cardiac disorders
Heart failure deterioration, myocardial infarction, venous thrombosis, death
|
0.51%
1/198 • Number of events 1 • 1 year
|
0.00%
0/194 • 1 year
|
|
Cardiac disorders
Heart failure deterioration, phrenic nerve stimulation
|
0.00%
0/198 • 1 year
|
0.52%
1/194 • Number of events 1 • 1 year
|
|
Cardiac disorders
Myocardial ischemia, staged heart bypass surgery
|
0.00%
0/198 • 1 year
|
0.52%
1/194 • Number of events 1 • 1 year
|
|
Cardiac disorders
Chest distress, short breaths
|
0.51%
1/198 • Number of events 1 • 1 year
|
0.00%
0/194 • 1 year
|
|
Vascular disorders
Cerebral hemorrhage, death
|
0.00%
0/198 • 1 year
|
0.52%
1/194 • Number of events 1 • 1 year
|
|
Cardiac disorders
Haematoma, low right atrial lead sensing
|
0.00%
0/198 • 1 year
|
0.52%
1/194 • Number of events 1 • 1 year
|
|
Cardiac disorders
pacemaker pocket ulceration
|
0.51%
1/198 • Number of events 1 • 1 year
|
0.00%
0/194 • 1 year
|
|
Cardiac disorders
pacemaker reject
|
0.51%
1/198 • Number of events 1 • 1 year
|
0.00%
0/194 • 1 year
|
Other adverse events
| Measure |
Quickopt Group
n=198 participants at risk
the QuickOpt Group patients will be optimized by QuickOpt(IEGM);
Cardiac Resynchronization Therapy: Patients will be optimized using QuickOpt (IEGM) algorithm installed on the Merlin device programmer within 2 weeks and 3 and 6 months after device implantation.
|
Echocardiography Group
n=194 participants at risk
the Echo Group patients will be optimized by Echo.
Optimization using echocardiography: Optimization of the AV/PV and VV delays using echocardiography
|
|---|---|---|
|
Cardiac disorders
Phrenic nerve stimulation
|
0.51%
1/198 • Number of events 1 • 1 year
|
1.0%
2/194 • Number of events 2 • 1 year
|
|
Cardiac disorders
Elevated left ventricular pacing threshold
|
1.0%
2/198 • Number of events 2 • 1 year
|
0.00%
0/194 • 1 year
|
|
Cardiac disorders
Coronary sinus dissection
|
0.51%
1/198 • Number of events 1 • 1 year
|
0.00%
0/194 • 1 year
|
|
Cardiac disorders
Right ventricular lead dislocation/displacement
|
0.51%
1/198 • Number of events 1 • 1 year
|
0.00%
0/194 • 1 year
|
|
Cardiac disorders
Right atrial lead dislocation/displacement
|
0.00%
0/198 • 1 year
|
0.52%
1/194 • Number of events 1 • 1 year
|
|
Cardiac disorders
Left ventricular lead dislocation/displacement
|
0.51%
1/198 • Number of events 1 • 1 year
|
0.00%
0/194 • 1 year
|
|
Cardiac disorders
Elevated pacing threshold of left ventricular lead; lead dislocation/displacem
|
0.00%
0/198 • 1 year
|
0.52%
1/194 • Number of events 1 • 1 year
|
|
Infections and infestations
Infection at pacing system
|
0.00%
0/198 • 1 year
|
0.52%
1/194 • Number of events 1 • 1 year
|
|
Immune system disorders
Anaphylactic shock
|
0.00%
0/198 • 1 year
|
0.52%
1/194 • Number of events 1 • 1 year
|
Additional Information
Clay Cohorn, Program Director
CRT, Global Clinical Affairs, Cardiac Arrhythmias and Heart Failure, Abbott Medical Devices
Phone: +1 972 309 8087
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place