Trial Outcomes & Findings for TReatment of Atrial Fibrillation With Dual dEfibrillator in Heart Failure Patients (NCT NCT00345592)
NCT ID: NCT00345592
Last Updated: 2017-03-28
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
420 participants
Primary outcome timeframe
3 years from randomization (39 months total)
Results posted on
2017-03-28
Participant Flow
First patient was enrolled on the 3rd of October, 2006. Last patient was enrolled on the 29th of July 2009, for a total of 420 patients.
24 subjects were not randomized: * 7 died before randomization (causes: 3 cardiac, 2 non-cardiac, 2 unknown); * 7 voluntarily withdrew; * 5 withdrawn due to AF. * 2 had device explanted before randomization; * 1 had biventricular pacing turned OFF * 1 was withdrawn from the study for inclusion criteria violation; * 1 lost to follow up.
Participant milestones
| Measure |
Device Managed Arm
Device-managed therapy arm. Shock therapy for atrial arrhythmias is delivered automatically from the device.
Dual (atrial and ventricular) implantable defibrillator: The devices automatically applies therapy (shock) for atrial fibrillation, when atrial fibrillation is confirmed.
|
Traditional Arm
Traditional therapy arm. In this arm, therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment. Therefore, patients who will experience symptoms at home, will refer to their center, eventually hospitalized and treated for atrial arrhythmias.
Dual (atrial and ventricular) implantable defibrillator: In hospital application of anti arrhythmic therapies via the device
Dual (atrial and ventricular) implantable defibrillator: Therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment
|
|---|---|---|
|
Overall Study
STARTED
|
199
|
197
|
|
Overall Study
COMPLETED
|
174
|
173
|
|
Overall Study
NOT COMPLETED
|
25
|
24
|
Reasons for withdrawal
| Measure |
Device Managed Arm
Device-managed therapy arm. Shock therapy for atrial arrhythmias is delivered automatically from the device.
Dual (atrial and ventricular) implantable defibrillator: The devices automatically applies therapy (shock) for atrial fibrillation, when atrial fibrillation is confirmed.
|
Traditional Arm
Traditional therapy arm. In this arm, therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment. Therefore, patients who will experience symptoms at home, will refer to their center, eventually hospitalized and treated for atrial arrhythmias.
Dual (atrial and ventricular) implantable defibrillator: In hospital application of anti arrhythmic therapies via the device
Dual (atrial and ventricular) implantable defibrillator: Therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment
|
|---|---|---|
|
Overall Study
Death
|
14
|
16
|
|
Overall Study
Withdrawal by Subject
|
11
|
8
|
Baseline Characteristics
TReatment of Atrial Fibrillation With Dual dEfibrillator in Heart Failure Patients
Baseline characteristics by cohort
| Measure |
Device Managed Arm
n=199 Participants
Device-managed therapy arm. Shock therapy for atrial arrhythmias is delivered automatically from the device.
Dual (atrial and ventricular) implantable defibrillator: The devices automatically applies therapy (shock) for atrial fibrillation, when atrial fibrillation is confirmed.
|
Traditional Arm
n=197 Participants
Traditional therapy arm. In this arm, therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment. Therefore, patients who will experience symptoms at home, will refer to their center, eventually hospitalized and treated for atrial arrhythmias.
Dual (atrial and ventricular) implantable defibrillator: In hospital application of anti arrhythmic therapies via the device
Dual (atrial and ventricular) implantable defibrillator: Therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment
|
Total
n=396 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67 years
STANDARD_DEVIATION 10 • n=99 Participants
|
68 years
STANDARD_DEVIATION 10 • n=107 Participants
|
67 years
STANDARD_DEVIATION 10 • n=206 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
85 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
152 Participants
n=99 Participants
|
159 Participants
n=107 Participants
|
311 Participants
n=206 Participants
|
|
Region of Enrollment
Italy
|
199 participants
n=99 Participants
|
197 participants
n=107 Participants
|
396 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 3 years from randomization (39 months total)Outcome measures
| Measure |
Device Managed Arm
n=199 Participants
Device-managed therapy arm. Shock therapy for atrial arrhythmias is delivered automatically from the device.
Dual (atrial and ventricular) implantable defibrillator: The devices automatically applies therapy (shock) for atrial fibrillation, when atrial fibrillation is confirmed.
|
Traditional Arm
n=197 Participants
Traditional therapy arm. In this arm, therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment. Therefore, patients who will experience symptoms at home, will refer to their center, eventually hospitalized and treated for atrial arrhythmias.
Dual (atrial and ventricular) implantable defibrillator: In hospital application of anti arrhythmic therapies via the device
Dual (atrial and ventricular) implantable defibrillator: Therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment
|
|---|---|---|
|
Unplanned Hospital Admissions for Cardiac Reasons OR Death of Cardiovascular Causes OR Progression to Chronic Atrial Fibrillation
|
43 participants
|
44 participants
|
Adverse Events
Device Managed Arm
Serious events: 103 serious events
Other events: 39 other events
Deaths: 0 deaths
Traditional Arm
Serious events: 93 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Device Managed Arm
n=199 participants at risk
Device-managed therapy arm. Shock therapy for atrial arrhythmias is delivered automatically from the device.
Dual (atrial and ventricular) implantable defibrillator: The devices automatically applies therapy (shock) for atrial fibrillation, when atrial fibrillation is confirmed.
|
Traditional Arm
n=197 participants at risk
Traditional therapy arm. In this arm, therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment. Therefore, patients who will experience symptoms at home, will refer to their center, eventually hospitalized and treated for atrial arrhythmias.
Dual (atrial and ventricular) implantable defibrillator: In hospital application of anti arrhythmic therapies via the device
Dual (atrial and ventricular) implantable defibrillator: Therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment
|
|---|---|---|
|
Cardiac disorders
atrial fibrillation
|
5.0%
10/199 • Number of events 11
|
3.6%
7/197 • Number of events 9
|
|
Cardiac disorders
worsening of cardiac disorders
|
8.0%
16/199 • Number of events 16
|
7.1%
14/197 • Number of events 14
|
|
General disorders
hopspitalizatin/intervention
|
39.2%
78/199 • Number of events 85
|
29.4%
58/197 • Number of events 74
|
|
Cardiac disorders
transplant
|
3.0%
6/199 • Number of events 6
|
2.0%
4/197 • Number of events 4
|
|
General disorders
worsening of non-cardiac disorders
|
4.0%
8/199 • Number of events 8
|
5.1%
10/197 • Number of events 10
|
|
General disorders
worsening of unknown conditions leading to death
|
6.5%
13/199 • Number of events 13
|
3.6%
7/197 • Number of events 7
|
Other adverse events
| Measure |
Device Managed Arm
n=199 participants at risk
Device-managed therapy arm. Shock therapy for atrial arrhythmias is delivered automatically from the device.
Dual (atrial and ventricular) implantable defibrillator: The devices automatically applies therapy (shock) for atrial fibrillation, when atrial fibrillation is confirmed.
|
Traditional Arm
n=197 participants at risk
Traditional therapy arm. In this arm, therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment. Therefore, patients who will experience symptoms at home, will refer to their center, eventually hospitalized and treated for atrial arrhythmias.
Dual (atrial and ventricular) implantable defibrillator: In hospital application of anti arrhythmic therapies via the device
Dual (atrial and ventricular) implantable defibrillator: Therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment
|
|---|---|---|
|
Cardiac disorders
device reprogramming
|
8.0%
16/199 • Number of events 17
|
7.1%
14/197 • Number of events 15
|
|
General disorders
clinical observation
|
12.1%
24/199 • Number of events 24
|
4.1%
8/197 • Number of events 8
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place