Trial Outcomes & Findings for Benefit of Dual-chamber Pacing With Closed Loop Stimulation (CLS) in Tilt-induced Cardioinhibitory Reflex Syncope (NCT NCT02324920)
NCT ID: NCT02324920
Last Updated: 2021-11-17
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
128 participants
Primary outcome timeframe
24 months
Results posted on
2021-11-17
Participant Flow
Participant milestones
| Measure |
Active Pacing (DDD+CLS)
The pacemaker will be programmed in a dual-chamber DDD pacing mode with the Closed Loop Stimulation (CLS) function ON.
DDD-CLS
|
Inactive Pacing (ODO)
The pacemaker will be programmed in ODO mode.
ODO
|
|---|---|---|
|
Overall Study
STARTED
|
64
|
64
|
|
Overall Study
COMPLETED
|
63
|
64
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Benefit of Dual-chamber Pacing With Closed Loop Stimulation (CLS) in Tilt-induced Cardioinhibitory Reflex Syncope
Baseline characteristics by cohort
| Measure |
Active Pacing (DDD+CLS)
n=63 Participants
The pacemaker will be programmed in a dual-chamber DDD pacing mode with the Closed Loop Stimulation (CLS) function ON.
DDD-CLS
|
Inactive Pacing (ODO)
n=64 Participants
The pacemaker will be programmed in ODO mode.
ODO
|
Total
n=127 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63 years
n=99 Participants
|
63 years
n=107 Participants
|
63 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
82 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
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 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
|
63 Participants
n=99 Participants
|
64 Participants
n=107 Participants
|
127 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 24 monthsOutcome measures
| Measure |
Active Pacing (DDD+CLS)
n=63 Participants
The pacemaker will be programmed in a dual-chamber DDD pacing mode with the Closed Loop Stimulation (CLS) function ON.
DDD-CLS
|
Inactive Pacing (ODO)
n=64 Participants
The pacemaker will be programmed in ODO mode.
ODO
|
|---|---|---|
|
Patients With Recurrence of Syncopal Episode
|
10 Participants
|
34 Participants
|
SECONDARY outcome
Timeframe: 24 monthsOutcome measures
| Measure |
Active Pacing (DDD+CLS)
n=63 Participants
The pacemaker will be programmed in a dual-chamber DDD pacing mode with the Closed Loop Stimulation (CLS) function ON.
DDD-CLS
|
Inactive Pacing (ODO)
n=64 Participants
The pacemaker will be programmed in ODO mode.
ODO
|
|---|---|---|
|
Patients With Recurrence of Pre-syncope or Syncope
|
24 Participants
|
40 Participants
|
Adverse Events
Active Pacing (DDD+CLS)
Serious events: 4 serious events
Other events: 20 other events
Deaths: 0 deaths
Inactive Pacing (ODO)
Serious events: 4 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Active Pacing (DDD+CLS)
n=64 participants at risk
The pacemaker will be programmed in a dual-chamber DDD pacing mode with the Closed Loop Stimulation (CLS) function ON.
DDD-CLS
|
Inactive Pacing (ODO)
n=64 participants at risk
The pacemaker will be programmed in ODO mode.
ODO
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Subtalar arthrodesis
|
0.00%
0/64 • median follow-up period of 14.1 months
|
1.6%
1/64 • Number of events 1 • median follow-up period of 14.1 months
|
|
Musculoskeletal and connective tissue disorders
inguinal hernia
|
1.6%
1/64 • Number of events 1 • median follow-up period of 14.1 months
|
0.00%
0/64 • median follow-up period of 14.1 months
|
|
Cardiac disorders
NSTEMI
|
0.00%
0/64 • median follow-up period of 14.1 months
|
1.6%
1/64 • Number of events 1 • median follow-up period of 14.1 months
|
|
Cardiac disorders
atrial fibrillation
|
1.6%
1/64 • Number of events 1 • median follow-up period of 14.1 months
|
0.00%
0/64 • median follow-up period of 14.1 months
|
|
Nervous system disorders
syncope
|
0.00%
0/64 • median follow-up period of 14.1 months
|
1.6%
1/64 • Number of events 1 • median follow-up period of 14.1 months
|
|
Cardiac disorders
pericarditis
|
1.6%
1/64 • Number of events 1 • median follow-up period of 14.1 months
|
0.00%
0/64 • median follow-up period of 14.1 months
|
|
Cardiac disorders
lead dislodgement
|
1.6%
1/64 • Number of events 1 • median follow-up period of 14.1 months
|
0.00%
0/64 • median follow-up period of 14.1 months
|
|
Cardiac disorders
lead was not properly connected to the pacemaker
|
0.00%
0/64 • median follow-up period of 14.1 months
|
1.6%
1/64 • Number of events 1 • median follow-up period of 14.1 months
|
Other adverse events
| Measure |
Active Pacing (DDD+CLS)
n=64 participants at risk
The pacemaker will be programmed in a dual-chamber DDD pacing mode with the Closed Loop Stimulation (CLS) function ON.
DDD-CLS
|
Inactive Pacing (ODO)
n=64 participants at risk
The pacemaker will be programmed in ODO mode.
ODO
|
|---|---|---|
|
Nervous system disorders
syncope
|
15.6%
10/64 • Number of events 10 • median follow-up period of 14.1 months
|
51.6%
33/64 • Number of events 33 • median follow-up period of 14.1 months
|
|
Cardiac disorders
presyncope
|
7.8%
5/64 • Number of events 5 • median follow-up period of 14.1 months
|
3.1%
2/64 • Number of events 2 • median follow-up period of 14.1 months
|
|
Skin and subcutaneous tissue disorders
Keloid formation
|
0.00%
0/64 • median follow-up period of 14.1 months
|
1.6%
1/64 • Number of events 1 • median follow-up period of 14.1 months
|
|
Skin and subcutaneous tissue disorders
mild pocket bleeding
|
0.00%
0/64 • median follow-up period of 14.1 months
|
1.6%
1/64 • Number of events 1 • median follow-up period of 14.1 months
|
|
Skin and subcutaneous tissue disorders
unspecified pain around the chest/ pocket.
|
1.6%
1/64 • Number of events 1 • median follow-up period of 14.1 months
|
0.00%
0/64 • median follow-up period of 14.1 months
|
|
Cardiac disorders
palpitations
|
1.6%
1/64 • Number of events 1 • median follow-up period of 14.1 months
|
0.00%
0/64 • median follow-up period of 14.1 months
|
|
Cardiac disorders
inappropriate pacing due to undersensing
|
1.6%
1/64 • Number of events 1 • median follow-up period of 14.1 months
|
0.00%
0/64 • median follow-up period of 14.1 months
|
|
Cardiac disorders
chest pain
|
1.6%
1/64 • Number of events 1 • median follow-up period of 14.1 months
|
1.6%
1/64 • Number of events 1 • median follow-up period of 14.1 months
|
|
Renal and urinary disorders
incontinence
|
1.6%
1/64 • Number of events 1 • median follow-up period of 14.1 months
|
0.00%
0/64 • median follow-up period of 14.1 months
|
|
Respiratory, thoracic and mediastinal disorders
fatigue (mild obstructive sleep apnea syndrome)
|
0.00%
0/64 • median follow-up period of 14.1 months
|
1.6%
1/64 • Number of events 1 • median follow-up period of 14.1 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60