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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device managed arm | Experimental | Device-managed therapy arm. Shock therapy for atrial arrhythmias is delivered automatically from the device. |
|
| Traditional arm | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dual (atrial and ventricular) implantable defibrillator | Device | The devices automatically applies therapy (shock) for atrial fibrillation, when atrial fibrillation is confirmed. |
| Measure | Description | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gianluca Botto, MD | Azienda Ospedale S. Anna | Principal Investigator |
| Luigi Padeletti, MD | Istituto di Clinica Medica I° e Cardiologia A.O.C. Careggi | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto di Clinica Medica I° e Cardiologia A.O.C. | Careggi | Italy | ||||
| Azienda Ospedale S. Anna |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21324118 | Derived | Botto GL, Boriani G, Favale S, Landolina M, Molon G, Tondo C, Biffi M, Grandinetti G, De Filippo P, Raciti G, Padeletti L. Treatment of atrial fibrillation with a dual defibrillator in heart failure patients (TRADE HF): protocol for a randomized clinical trial. Trials. 2011 Feb 15;12:44. doi: 10.1186/1745-6215-12-44. |
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24 subjects were not randomized:
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Dual (atrial and ventricular) implantable defibrillator | Device | In hospital application of anti arrhythmic therapies via the device |
|
| Dual (atrial and ventricular) implantable defibrillator | Device | Therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment |
|
| San Fermo Della Battaglia (CO) |
| Italy |
| 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 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Unplanned Hospital Admissions for Cardiac Reasons OR Death of Cardiovascular Causes OR Progression to Chronic Atrial Fibrillation | Posted | Number | participants | 3 years from randomization (39 months total) |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 103 | 199 | 39 | 199 | ||
| EG001 | 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 | 93 | 197 | 22 | 197 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| atrial fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| worsening of cardiac disorders | Cardiac disorders | Systematic Assessment | events leading to death |
| |
| hopspitalizatin/intervention | General disorders | Systematic Assessment | including cardiac and non cardiac hospitalizations |
| |
| transplant | Cardiac disorders | Systematic Assessment |
| ||
| worsening of non-cardiac disorders | General disorders | Systematic Assessment | events leading to death |
| |
| worsening of unknown conditions leading to death | General disorders | Systematic Assessment | include all the events leading to out of hospital death for unknown or undetermined conditions |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| device reprogramming | Cardiac disorders | Systematic Assessment | need to change device settings due to patient sysmptoms or adverse device effect, without invasive intervention |
| |
| clinical observation | General disorders | Systematic Assessment | not requiring intervention |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Giovanni Luca Botto | S. Anna Hospital | 0315851 | +39 | gluca.botto@gmail.com |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D017147 | Defibrillators, Implantable |
| ID | Term |
|---|---|
| D047548 | Defibrillators |
| D004566 | Electrodes |
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
| D004567 | Electrodes, Implanted |
| D019736 | Prostheses and Implants |
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| Male |
|