Study cz-010220121030
Study Name
Prophylactic use of implantable cardioverter-defibrillators for ventricular arrhythmias after cardiac surgery
Clinical Trial Registry Identifier
cz-010220121030
Study First Received
01.02.2012 10:30
Sponsor
Faculty of Health and Social Studies, South Bohemia University, Budweis, Czech Republic, grant BOV2012_001
Principal Investigator
Cardiac Centre Vysocina Czech Republic Martin Eisenberger, IKEM Prague Czech Republic Kamil Sedlacek MD, FNOL Olomouc Czech Republic Marian Fedorco MD, Alst Belgium Peeter Geelen MD
Information provided by
Martin Eisenberger
Purpose
The purpose of this study is to find predictors that would identify patients in high risk of malignant arrhythmia recurrence after an episode of VT/VF in the setting of a recent cardiac surgery. It is currently unknown whether patients with malignant arrhythmias in the setting of a recent cardiac surgery are in a risk of arrhythmia recurrence. We are aiming to evaluate the rate and predictors of appropriate ICD therapies during long-term follow-up. Details on demographic variables, underlying disease, ECG, echocardiography prior to the arrhythmia event, results of coronary angiography, surgical history and electrophysiology studies will be collected from all patients. All patients will have follow-ups scheduled at 3 months after device implantation and every 12 months thereafter.
Primary endpoints
ICD therapy (i.e. shocks or antitachycardia pacing) for ventricular fibrillation or ventricular tachycardia
Secondary endpoints
Cardiac death Determine if LV ejection fraction, creatinine level or ECG measures can predict ICD therapies
Eligibility
Patients who underwent an implantable cardioverter-defibrillator insertion for an episode of VT/VF that developed 1 to 7 days after cardiac surgery will be recruited to the study. Patients with ventricular arrhythmias due to reversible causes such as myocardial ischemia, infarction or electrolyte abnormalities will not be eligible.
Contacts and Locations
Martin Eisenberger, +420 775 087 299 Cardiac Centre Vysocina, Vysocina Hospital, Jihlava, Czech Republic Institute for clinical and experimental medicine, Prague, Czech Republic Department of internal medicine – cardiology, University Hospital Olomouc, Czech Republic Arrhythmia Unit, OLV Hospital, Aalst, Belgium Prof. Robert Hatala, Department of Arrhythmias and Cardiac Pacing, National Institute of Cardiovascular Diseases, Bratislava, Slovakia
More Information
No publications provided
Keywords
Implantable cardioverter-defibrillator, ventricular tachycardia, ventricular fibrillation, cardiac surgery,
Status
Ongoing - recruiting
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