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Treatment of atrial fibrillation with a dual defibrillator in heart failure patients (TRADE HF): protocol for a randomized clinical trial.
- Source :
-
Trials [Trials] 2011 Feb 15; Vol. 12, pp. 44. Date of Electronic Publication: 2011 Feb 15. - Publication Year :
- 2011
-
Abstract
- Background: Heart failure(HF) and atrial fibrillation(AF) frequently coexist in the same patient and are associated with increased mortality and frequent hospitalizations. As the concomitance of AF and HF is often associated with a poor prognosis, the prompt treatment of AF in HF patients may significantly improve outcome.<br />Methods/design: Recent implantable cardiac resynchronization (CRT) devices allow electrical therapies to treat AF automatically. TRADE-HF (trial registration: NCT00345592; http://www.clinicaltrials.gov) is a prospective, randomized, double arm study aimed at demonstrating the efficacy of an automatic, device-based therapy for treatment of atrial tachycardia and fibrillation(AT/AF) in patients indicated for CRT. The study compares automatic electrical therapy to a traditional more usual treatment of AT/AF: the goal is to demonstrate a reduction in a combined endpoint of unplanned hospitalizations for cardiac reasons, death from cardiovascular causes or permanent AF when using automatic atrial therapy as compared to the traditional approach involving hospitalization for symptoms and in-hospital treatment of AT/AF.<br />Discussion: CRT pacemaker with the additional ability to convert AF as well as ventricular arrhythmias may play a simultaneous role in rhythm control and HF treatment. The value of the systematic implantation of CRT ICDs with the capacity to deliver atrial therapy in HF patients at risk of AF has not yet been explored. The TRADE-HF study will assess in CRT patients whether a strategy based on automatic management of atrial arrhythmias might be a valuable option to reduce the number of hospital admission and to reduce the progression the arrhythmia to a permanent form.<br />Trial Registration: NCT00345592.
- Subjects :
- Atrial Fibrillation complications
Atrial Fibrillation mortality
Atrial Fibrillation physiopathology
Equipment Design
Heart Failure complications
Heart Failure mortality
Heart Failure physiopathology
Hospitalization
Humans
Italy
Prospective Studies
Treatment Outcome
Atrial Fibrillation therapy
Cardiac Resynchronization Therapy adverse effects
Cardiac Resynchronization Therapy mortality
Cardiac Resynchronization Therapy Devices
Defibrillators, Implantable
Heart Failure therapy
Research Design
Subjects
Details
- Language :
- English
- ISSN :
- 1745-6215
- Volume :
- 12
- Database :
- MEDLINE
- Journal :
- Trials
- Publication Type :
- Academic Journal
- Accession number :
- 21324118
- Full Text :
- https://doi.org/10.1186/1745-6215-12-44