Extrait

Background and study aims This study aims to compare the efficiency between catheters used for radiofrequency ablation (RFCA), a procedure to correct irregularity in the heart rhythm, of accessory pathways in the heart and irregular heartbeat (arrhythmia). Our goal is to find the best catheter and energy settings for different locations of irregularity (arrhythmic focus). For many years, non-irrigated tip catheters have been used for this procedure. Irrigated-tip catheters work better and have fewer risks of blood clot. We want to look at whether COOL-Tip catheters can be used as a universal catheter for all locations and whether they work faster. Who can participate? The study aims to recruit about 200 patients, both male and female of age > 18 years from 4 Polish hospitals: Warsaw, Wroclaw, Radom and Ostrowiec Swietokrzyski. What does the study involve? Patients will be randomly allocated to two groups: one receiving treatment with COOL-Tip catheters and the other with the usual 4mm catheters. Patients will be followed for 12 months after the procedure. Arrhythmia or ACP recurrence data, information about the course of the procedure and information regarding early and late complications will be collected. Observation will include follow-up visits 1, 6 and 12 months after the RFCA procedure. A standard internet-based database will be provided to all participating sites. It will include standard electronic study forms and documentation of the clinical status of the patient. Follow-up visits will be conducted by an electrophysiology specialist in an outpatient setting. Before each follow-up visit, a 24-hour Holter test (to continuously record the heart's rhythms) will be scheduled. In case of undocumented pounding or racing of heart, typical of the ablated arrhythmia, the patient shall receive an arrhythmia recorder to confirm the recurrence of the ablated arrhythmia. If information could not be collected during follow-up visits, it will be recorded by a qualified nurse during analysis of the patient files, the patient’s family files, medical data and medical files kept by the general practitioner/treating physician. What are the possible benefits and risks of participating? Performance of the procedure by an experienced specialist will be the benefit for the patient, regardless of the random group assignment. Upon inclusion in the study, the patient benefits from contact and follow-up visits within 12 months of the procedure, conducted directly by the specialist performing the ablation procedure. Approved catheters bearing the CE mark will be used during the study. The risk is limited to standard complications connected with ablation procedures. Where is the study run from? The study is run from the Regional Specialist Hospital, Research and Development Centre, Wroclaw (Poland). When is the study starting and how long is it expected The recruitment starts in March 2013. Patients will be enrolled in the study for a period of one year. Who is the main contact? Dr Sebastian Stec [email protected]

Critère d'inclusion

• Accessory pathways and idiopathic ventricular arrhythmias

Liens

• ictrp
• isrctn