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

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ClinicalTrials.gov Identifier: NCT00180427
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : April 24, 2008
Sponsor:
Information provided by:
Guidant Corporation

September 12, 2005
September 16, 2005
April 24, 2008
June 2001
Not Provided
frequency of ventricular arrhythmias at 6 and 12 months follow ups
Same as current
Complete list of historical versions of study NCT00180427 on ClinicalTrials.gov Archive Site
medication, anamnesis, quality of life, 6 min walktest, echocardiographic parameters and optionally spiroergomatry at 6 and 12 months follow ups,
Same as current
Not Provided
Not Provided
 
VERRARI - "Are Ventricular Arrhythmic Episodes Reduced by Rate Response in ICDs?"
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."

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Ventricular Fibrillation
Device: ICD
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
75
Same as current
November 2004
Not Provided

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"
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00180427
Version vom 01.03.2001
Not Provided
Not Provided
Not Provided
Not Provided
Guidant Corporation
Not Provided
Principal Investigator: Michael Niehaus, MD Hannover Medical School
Guidant Corporation
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP