Ventricular Fibrillation Clinical Trial
Official title:
VERRARI - "Are Ventricular Arrhythmic Episodes Reduced by Rate Response in ICDs?"
"The purpose of this study is to evaluate the influence of the rate response function of implantable cardioverter defibrillators (ICDs) on the frequency of ventricular arrhythmias in patients with an ICD."
"Background: Studies have shown that bradycardia and irregular heart rates may increase the
incidence of ventricular arrhythmias. Regularizing the heart rate and avoiding bradycardias
by rate responsive pacing may be a way to reduce these arrhythmias.
This is a prospective, open-label, randomized multicenter study. Inclusion criteria:
Patients with an indication for an ICD according to the AHA/ACC-guidelines who get a rate
response system and have more than 5 % rate adaptive pacing during a one month screening
phase may be included if they have given written informed consent. Rate adaptive pacing must
not be contraindicated, patients must be able to perform a 6 min walk test, must not be NYHA
IV and should have a life expectancy of more than 18 months.
Patients will be randomly assigned to 6 months of rate responsive pacing followed by 6
months of no rate responsive pacing, vice versa respectively. At 6 and 12 months follow ups,
ICD stored data, arrhythmic episodes, medication, anamnesis, quality of life, 6 min
walktest, echocardiographic parameters and optionally spiroergomatry will be evaluated and
compared."
;
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention
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