VERRARI - "Are Ventricular Arrhythmic Episodes Reduced by Rate Response in ICDs?"
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
|Official Title:||VERRARI - "Are Ventricular Arrhythmic Episodes Reduced by Rate Response in ICDs?"|
- frequency of ventricular arrhythmias at 6 and 12 months follow ups
- medication, anamnesis, quality of life, 6 min walktest, echocardiographic parameters and optionally spiroergomatry at 6 and 12 months follow ups,
|Study Start Date:||June 2001|
|Study Completion Date:||November 2004|
"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."
Please refer to this study by its ClinicalTrials.gov identifier: NCT00180427
|Medizinische Klinik der Medizinischen Hochschule|
|Principal Investigator:||Michael Niehaus, MD||Hannover Medical School|