VERRARI - "Are Ventricular Arrhythmic Episodes Reduced by Rate Response in ICDs?"
Primary Purpose
Ventricular Fibrillation
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
ICD
Sponsored by
About this trial
This is an interventional prevention trial for Ventricular Fibrillation
Eligibility Criteria
Inclusion Criteria: 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 Criteria: rate responsive pacing contraindicated patient not able to perform 6 min walktest heart failure NYHA IV life expectancy below 18 months"
Sites / Locations
- Medizinische Klinik der Medizinischen Hochschule
Outcomes
Primary Outcome Measures
frequency of ventricular arrhythmias at 6 and 12 months follow ups
Secondary Outcome Measures
medication, anamnesis, quality of life, 6 min walktest, echocardiographic parameters and optionally spiroergomatry at 6 and 12 months follow ups,
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00180427
Brief Title
VERRARI - "Are Ventricular Arrhythmic Episodes Reduced by Rate Response in ICDs?"
Official Title
VERRARI - "Are Ventricular Arrhythmic Episodes Reduced by Rate Response in ICDs?"
Study Type
Interventional
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
June 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Guidant Corporation
4. Oversight
5. Study Description
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 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 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."
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Fibrillation
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
ICD
Primary Outcome Measure Information:
Title
frequency of ventricular arrhythmias at 6 and 12 months follow ups
Secondary Outcome Measure Information:
Title
medication, anamnesis, quality of life, 6 min walktest, echocardiographic parameters and optionally spiroergomatry at 6 and 12 months follow ups,
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
rate responsive pacing contraindicated
patient not able to perform 6 min walktest
heart failure NYHA IV
life expectancy below 18 months"
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Niehaus, MD
Organizational Affiliation
Hannover Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medizinische Klinik der Medizinischen Hochschule
City
Hannover
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
VERRARI - "Are Ventricular Arrhythmic Episodes Reduced by Rate Response in ICDs?"
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