Supervisors info:
Κίμων Σταματελόπουλος, Αναπληρωτής Καθηγητής,Ιατρική Σχολή, ΕΚΠΑ
Καστρίτης Ευστάθιος , Αναπληρωτής Καθηγητής, Ιατρική Σχολή, ΕΚΠΑ
Μήγκου Μαγδαληνή: Διδάκτωρ Ιατρικής, Επιστημονική συνεργάτης θεραπευτικής κλινικής, ΕΚΠΑ
Summary:
The permanent pacemaker has evolved dramatically towards its function and construction in order to have the best therapeutic approach and effect in all approach of patients.
This development was based on many of clinical trials to find the right type of pacemaker for every type of bradycardia and heart problem. Most studies began as a case study, followed by retrospective or progressive observational studies, recording the progress of patients who had a pacemaker. They continued with the randomized studies phase II and III, which were interventional randomized, controlled by parallel groups, double-blind, placebo pacemaker, multicenter, and randomized, double-blind, controlled with placebo pacemaker, crossover, and finally the meta-analysis.
Clinical trials were based on bradycardia (sinus disease, atrioventricular block), documented intermittent bradycardia (atrial fibrillation with slow ventricular conduction, reflex of syncope,), and suspected bradycardia (asymptomatic bundle branch block, vasovagal syncope, syncope and unexplained fall).
In the retrospective and prospective observational study, non-invasive, the data was recorded for a period with no intervention to the patients, where they show that ventricular pacemakers have a higher mortality in sinus node diseases. In the intervention, randomized study, with a control group, with three arms, the randomization is done from a central computer which treatment (pacemaker or pill) the patient received and monitored for a specific period of time, the study have shown that in sinus disease are minimal versus the pill and non-treatment.
In a randomized, controlled with parallel groups, virtual pacemaker, double-blind, multicenter study, in which many investigative sites participate, the patients and the physicians didn’t know the treatment. They found that in vasovagal syncope, the double pacemaker reduced syncope.
In randomized, controlled with parallel groups, placebo pacemaker, double-blind, cross-centered and multicenter study, after a specific period of time, treatment was reversed in each group. Patients with syncope have been found to have greater survival by having a dual pacemaker.
Keywords:
Pacemaker, Cardiac pacing, Bradycardia, Sick Sinus Syndrome, Clinical trials
