Status:
COMPLETED
VERRARI - "Are Ventricular Arrhythmic Episodes Reduced by Rate Response in ICDs?"
Lead Sponsor:
Guidant Corporation
Conditions:
Ventricular Fibrillation
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
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 ...
Detailed Description
"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 responsi...
Eligibility Criteria
Inclusion
- indication for an ICD according to ACC/AHA guidelines
- ICD with rate response function implanted
- at least 5% rate response ventricular pacing during the one month screening phase
- signed informed patient consent"
Exclusion
- rate responsive pacing contraindicated
- patient not able to perform 6 min walktest
- heart failure NYHA IV
- life expectancy below 18 months"
Key Trial Info
Start Date :
June 1 2001
Trial Type :
INTERVENTIONAL
End Date :
November 1 2004
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00180427
Start Date
June 1 2001
End Date
November 1 2004
Last Update
April 24 2008
Active Locations (1)
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1
Medizinische Klinik der Medizinischen Hochschule
Hanover, Germany