Trial Outcomes & Findings for DATAS: The Dual Chamber & Atrial Tachyarrhythmias Adverse Events Study (NCT NCT00157820)
NCT ID: NCT00157820
Last Updated: 2025-07-02
Results Overview
Main outcome was defined as the CSAE-score during follow-up: CSAE-score rate. We assigned death as the worst outcome during the entire study; and premature cross-over as the main failure of the assigned therapy. So each CSAE was assigned 1 point but (a) death was assigned a score equal to the max number of CSAE in any individual patient in the entire study +1, and (b) premature authorized crossover was given a score equal to the max number of CSAE in any individual patient in that period. Thus, main outcome was defined as the CSAE-score over length of follow-up resulting in a CSAE-score rate.
COMPLETED
NA
354 participants
17 months
2025-07-02
Participant Flow
Patients were eligible if they met a standard Class I indication for a Single Chamber-Implantable Cardioverter Defibrillator (ICD) according to the 1998 ACC/AHA guidelines. Every patient eligible for ICD was screened at each study centre. Follow-up started immediately after randomization.
The Dual chamber true (DC true) and Single chamber simulated (SC sim) arms crossed over after 8 months. All other crossovers were considered 'premature crossovers' and had to be authorized by an independent Adverse Events Advisory Committee. A 1-month wash out period was implemented after programmed crossover.
Participant milestones
| Measure |
SC True
Allocated to Single Chamber ICD (SC true arm) VVEV-VVI (NASPE/BPEG Defibrillator/Pacemaker Codes)
|
SC Simulated Then DC True
Dual chamber ICD initially programmed as Single Chamber ICD (simulated) then DC true programmed as Dual Chamber true (DDED-DDDR) NASPE/BPEG Defibrillator/Pacemaker Codes.
|
DC True Then SC Sim
Dual chamber ICD initially programmed as a DDED-DDDR ("DC true arm") then programmed as Single Chamber simulated
|
|---|---|---|---|
|
Randomized
STARTED
|
118
|
116
|
120
|
|
Randomized
COMPLETED
|
111
|
111
|
112
|
|
Randomized
NOT COMPLETED
|
7
|
5
|
8
|
|
1st 8 Month
STARTED
|
111
|
111
|
112
|
|
1st 8 Month
COMPLETED
|
103
|
99
|
106
|
|
1st 8 Month
NOT COMPLETED
|
8
|
12
|
6
|
|
1 Month Wash Out Period
STARTED
|
103
|
101
|
108
|
|
1 Month Wash Out Period
COMPLETED
|
103
|
101
|
108
|
|
1 Month Wash Out Period
NOT COMPLETED
|
0
|
0
|
0
|
|
2nd 8 Months
STARTED
|
103
|
101
|
108
|
|
2nd 8 Months
COMPLETED
|
98
|
88
|
94
|
|
2nd 8 Months
NOT COMPLETED
|
5
|
13
|
14
|
Reasons for withdrawal
| Measure |
SC True
Allocated to Single Chamber ICD (SC true arm) VVEV-VVI (NASPE/BPEG Defibrillator/Pacemaker Codes)
|
SC Simulated Then DC True
Dual chamber ICD initially programmed as Single Chamber ICD (simulated) then DC true programmed as Dual Chamber true (DDED-DDDR) NASPE/BPEG Defibrillator/Pacemaker Codes.
|
DC True Then SC Sim
Dual chamber ICD initially programmed as a DDED-DDDR ("DC true arm") then programmed as Single Chamber simulated
|
|---|---|---|---|
|
Randomized
Physician Decision
|
4
|
2
|
3
|
|
Randomized
Withdrawal by Subject
|
1
|
2
|
3
|
|
Randomized
Protocol Violation
|
2
|
1
|
2
|
|
1st 8 Month
Death
|
7
|
8
|
3
|
|
1st 8 Month
Lost to Follow-up
|
1
|
2
|
1
|
|
1st 8 Month
Premature cross-over
|
0
|
2
|
2
|
|
2nd 8 Months
Death
|
3
|
1
|
3
|
|
2nd 8 Months
Lost to Follow-up
|
1
|
5
|
2
|
|
2nd 8 Months
Premature cross-over
|
1
|
7
|
9
|
Baseline Characteristics
DATAS: The Dual Chamber & Atrial Tachyarrhythmias Adverse Events Study
Baseline characteristics by cohort
| Measure |
SC True
n=111 Participants
Allocated to Single Chamber ICD (SC true arm) VVEV-VVI (NASPE/BPEG Defibrillator/Pacemaker Codes)
|
SC Simulated Then DC True
n=111 Participants
Dual chamber ICD initially programmed as Single Chamber ICD (simulated) then DC true programmed as Dual Chamber true (DDED-DDDR) NASPE/BPEG Defibrillator/Pacemaker Codes.
|
DC True Then SC Sim
n=112 Participants
Dual chamber ICD initially programmed as a DDED-DDDR ("DC true arm") then programmed as Single Chamber simulated
|
Total
n=334 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
63 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
177 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
48 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
157 Participants
n=4 Participants
|
|
Age, Continuous
|
63 years
STANDARD_DEVIATION 10 • n=5 Participants
|
62 years
STANDARD_DEVIATION 11 • n=7 Participants
|
66 years
STANDARD_DEVIATION 9 • n=5 Participants
|
64 years
STANDARD_DEVIATION 10 • n=4 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
100 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
282 Participants
n=4 Participants
|
|
Region of Enrollment
Spain
|
43 participants
n=5 Participants
|
44 participants
n=7 Participants
|
44 participants
n=5 Participants
|
131 participants
n=4 Participants
|
|
Region of Enrollment
Germany
|
29 participants
n=5 Participants
|
29 participants
n=7 Participants
|
31 participants
n=5 Participants
|
89 participants
n=4 Participants
|
|
Region of Enrollment
Italy
|
21 participants
n=5 Participants
|
21 participants
n=7 Participants
|
19 participants
n=5 Participants
|
61 participants
n=4 Participants
|
|
Region of Enrollment
Israel
|
9 participants
n=5 Participants
|
8 participants
n=7 Participants
|
9 participants
n=5 Participants
|
26 participants
n=4 Participants
|
|
Region of Enrollment
United Kingdom
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
18 participants
n=4 Participants
|
|
Region of Enrollment
Portugal
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
9 participants
n=4 Participants
|
|
LVEF
|
35 percentage
STANDARD_DEVIATION 13 • n=5 Participants
|
39 percentage
STANDARD_DEVIATION 14 • n=7 Participants
|
34 percentage
STANDARD_DEVIATION 12 • n=5 Participants
|
36 percentage
STANDARD_DEVIATION 13 • n=4 Participants
|
PRIMARY outcome
Timeframe: 17 monthsPopulation: ITT
Main outcome was defined as the CSAE-score during follow-up: CSAE-score rate. We assigned death as the worst outcome during the entire study; and premature cross-over as the main failure of the assigned therapy. So each CSAE was assigned 1 point but (a) death was assigned a score equal to the max number of CSAE in any individual patient in the entire study +1, and (b) premature authorized crossover was given a score equal to the max number of CSAE in any individual patient in that period. Thus, main outcome was defined as the CSAE-score over length of follow-up resulting in a CSAE-score rate.
Outcome measures
| Measure |
SC True
n=82 CSAE
Allocated to Single Chamber ICD (SC true arm)
|
SC Simulated
n=84 CSAE
Dual chamber ICD initially programmed as Single Chamber ICD (simulated)
|
DC True
n=65 CSAE
Dual chamber ICD initially programmed as a DDED-DDDR ("DC true arm"
|
|---|---|---|---|
|
CSAE-score Rate(Clinical Significant Adverse Events Score Rate)
|
0.112 score/month
|
0.128 score/month
|
0.075 score/month
|
SECONDARY outcome
Timeframe: 17 monthsThe primary endpoint is a composite of 5 pre-determine Clinical Significant Adverse Events (CSAE): (1) all-cause mortality, (2) invasive intervention due to Cardiovascular cause, (3) hospitalization (\>24h) or prolongation of hospitalization due to CV, (4) inappropriate shocks: two or more episodes with inappropriate shocks, (5) sustained symptomatic ATs that (a) require urgent termination or (b) lasted more than 48 h leading to therapeutic intervention. Number of each of the components of CSAE, counts the number of events for each pre-determined level.
Outcome measures
| Measure |
SC True
n=111 Participants
Allocated to Single Chamber ICD (SC true arm)
|
SC Simulated
n=223 Participants
Dual chamber ICD initially programmed as Single Chamber ICD (simulated)
|
DC True
n=223 Participants
Dual chamber ICD initially programmed as a DDED-DDDR ("DC true arm"
|
|---|---|---|---|
|
Number of Each of the Components of the CSAE
Death
|
10 events
|
11 events
|
4 events
|
|
Number of Each of the Components of the CSAE
Invasive intervention CV
|
11 events
|
12 events
|
10 events
|
|
Number of Each of the Components of the CSAE
Hospitalizations (>24h) or prolongued CV
|
42 events
|
51 events
|
47 events
|
|
Number of Each of the Components of the CSAE
Inappropiate shocks (>2 episodes)
|
13 events
|
7 events
|
3 events
|
|
Number of Each of the Components of the CSAE
Long Duration AT
|
6 events
|
3 events
|
1 events
|
Adverse Events
SC True
SC Simulated
DC True
Serious adverse events
| Measure |
SC True
n=111 participants at risk
Allocated to Single Chamber ICD (SC true arm)
|
SC Simulated
n=223 participants at risk
Dual chamber ICD initially programmed as Single Chamber ICD (simulated
|
DC True
n=223 participants at risk
Dual chamber ICD initially programmed as a DDED-DDDR ("DC true arm")
|
|---|---|---|---|
|
General disorders
Death
|
9.0%
10/111 • Number of events 10 • Duration of the enrollment+follow up
|
4.9%
11/223 • Number of events 11 • Duration of the enrollment+follow up
|
1.8%
4/223 • Number of events 4 • Duration of the enrollment+follow up
|
|
Cardiac disorders
Invasive interventions
|
9.9%
11/111 • Number of events 11 • Duration of the enrollment+follow up
|
5.4%
12/223 • Number of events 12 • Duration of the enrollment+follow up
|
4.0%
9/223 • Number of events 10 • Duration of the enrollment+follow up
|
|
Cardiac disorders
Hospitalization or prolongued hospitalizations
|
29.7%
33/111 • Number of events 42 • Duration of the enrollment+follow up
|
14.3%
32/223 • Number of events 51 • Duration of the enrollment+follow up
|
16.1%
36/223 • Number of events 47 • Duration of the enrollment+follow up
|
Other adverse events
| Measure |
SC True
n=111 participants at risk
Allocated to Single Chamber ICD (SC true arm)
|
SC Simulated
n=223 participants at risk
Dual chamber ICD initially programmed as Single Chamber ICD (simulated
|
DC True
n=223 participants at risk
Dual chamber ICD initially programmed as a DDED-DDDR ("DC true arm")
|
|---|---|---|---|
|
Cardiac disorders
Innapropiate shocks
|
9.0%
10/111 • Number of events 23 • Duration of the enrollment+follow up
|
3.1%
7/223 • Number of events 14 • Duration of the enrollment+follow up
|
0.90%
2/223 • Number of events 5 • Duration of the enrollment+follow up
|
|
Cardiac disorders
Sustain Symptomatic AT
|
4.5%
5/111 • Number of events 6 • Duration of the enrollment+follow up
|
1.8%
4/223 • Number of events 4 • Duration of the enrollment+follow up
|
0.45%
1/223 • Number of events 1 • Duration of the enrollment+follow up
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60