Clinical Trial: VERRARI - "Are Ventricular Arrhythmic Episodes Reduced by Rate Response in ICDs?"

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: VERRARI - "Are Ventricular Arrhythmic Episodes Reduced by Rate Response in ICDs?"

Brief Summary: "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."

Detailed Summary:

"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."

Sponsor: Guidant Corporation

Current Primary Outcome: frequency of ventricular arrhythmias at 6 and 12 months follow ups

Original Primary Outcome: Same as current

Current Secondary Outcome: medication, anamnesis, quality of life, 6 min walktest, echocardiographic parameters and optionally spiroergomatry at 6 and 12 months follow ups,

Original Secondary Outcome: Same as current

Information By: Guidant Corporation

Dates:
Date Received: September 12, 2005
Date Started: June 2001
Date Completion:
Last Updated: April 22, 2008
Last Verified: April 2008