Heart Failure, Congestive
Conditions
Brief summary
Demonstrate the efficacy of the device-based managed therapy to treat atrial tachycardia and fibrillation (AT/AF) in patients with CHF indication for implant of a CRT defibrillator and to demonstrate the advantage of automatic electrical therapy of atrial arrhythmias compared to an in-hospital approach for treatment of symptomatic AT/AF.
Interventions
DEVICEDual (atrial and ventricular) implantable defibrillator
The devices automatically applies therapy (shock) for atrial fibrillation, when atrial fibrillation is confirmed.
Sponsors
Boston Scientific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* chronic symptomatic HF despite stable, optimal drug therapy * indication for a cardiac resynchronisation device with defibrillator backup according to current guidelines * patients implanted with cardiac resynchronization device with dual (atrial and ventricular) defibrillation capabilities
Exclusion criteria
* Chronic atrial fibrillation * Valvular disease * patients who underwent or are planned for ablation of atrial fibrillation * cerebral vascular accident/transient ischemic attack within 12 months from implant which lead to relevant impairment * preexisting unipolar pacemaker
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Unplanned Hospital Admissions for Cardiac Reasons OR Death of Cardiovascular Causes OR Progression to Chronic Atrial Fibrillation | 3 years from randomization (39 months total) |
Countries
Italy
Participant flow
Recruitment details
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.
Pre-assignment details
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randomized: * 7 died before randomization (causes: 3 cardiac, 2 non-cardiac, 2 unknown); * 7 voluntarily withdrew; * 5 withdrawn due to AF. * 2 had device explanted before randomization; * 1 had biventricular pacing turned OFF * 1 was withdrawn from the study for inclusion criteria violation; * 1 lost to follow up.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 199 |
| 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 | 197 |
| Total | 396 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 14 | 16 |
| Overall Study | Withdrawal by Subject | 11 | 8 |
Baseline characteristics
| Characteristic | Device Managed Arm | Traditional Arm | Total |
|---|---|---|---|
| Age, Continuous | 67 years STANDARD_DEVIATION 10 | 68 years STANDARD_DEVIATION 10 | 67 years STANDARD_DEVIATION 10 |
| Region of Enrollment Italy | 199 participants | 197 participants | 396 participants |
| Sex: Female, Male Female | 47 Participants | 38 Participants | 85 Participants |
| Sex: Female, Male Male | 152 Participants | 159 Participants | 311 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 39 / 199 | 22 / 197 |
| serious Total, serious adverse events | 103 / 199 | 93 / 197 |
Outcome results
Primary
Unplanned Hospital Admissions for Cardiac Reasons OR Death of Cardiovascular Causes OR Progression to Chronic Atrial Fibrillation
Time frame: 3 years from randomization (39 months total)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Device Managed Arm | Unplanned Hospital Admissions for Cardiac Reasons OR Death of Cardiovascular Causes OR Progression to Chronic Atrial Fibrillation | 43 participants |
| Traditional Arm | Unplanned Hospital Admissions for Cardiac Reasons OR Death of Cardiovascular Causes OR Progression to Chronic Atrial Fibrillation | 44 participants |
95% CI: [0.684, 1.503]