NCT00345592|CompletedPhase 4ResultsDMC
TReatment of Atrial Fibrillation With Dual dEfibrillator in Heart Failure Patients
TRADE HF
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Sponsor study identifier
interventional
420
1 country
2
Study Start
October 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2012
Actual (reported)Study Completion
November 2012
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2012
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 27, 2006
Actual (reported)June 28, 2006
Actual (reported)October 2006
Date type not reportedThis date has not been verified as actual or estimated.
November 2012
Actual (reported)November 2012
Actual (reported)June 11, 2014
Actual (reported)Unplanned Hospital Admissions for Cardiac Reasons OR Death of Cardiovascular Causes OR Progression to Chronic Atrial Fibrillation
3 years from randomization (39 months total)
Device-managed therapy arm. Shock therapy for atrial arrhythmias is delivered automatically from the device.
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.
The devices automatically applies therapy (shock) for atrial fibrillation, when atrial fibrillation is confirmed.
In hospital application of anti arrhythmic therapies via the device
Istituto di Clinica Medica I° e Cardiologia A.O.C.
Careggi, Italy
Azienda Ospedale S. Anna
San Fermo Della Battaglia (CO), Italy
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.
Gianluca Botto, MD
Azienda Ospedale S. Anna
Luigi Padeletti, MD
Istituto di Clinica Medica I° e Cardiologia A.O.C. Careggi
420 participants (actual enrollment reported by the registry).
First Submitted
June 27, 2006
First Posted
June 28, 2006
Study Start
October 2006
Date type not reportedThis date has not been verified as actual or estimated.
PREVENT-HF: Prevention of Heart Failure Events With Impedance Cardiography Testing
Therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
November 2012
Actual (reported)Study Completion
November 2012
Actual (reported)Last Updated
March 28, 2017
Results First Posted
June 11, 2014
Record last verified: 2017-02
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Source: ClinicalTrials.gov.
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