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

This study has been completed.
Sponsor:
Information provided by:
Guidant Corporation
ClinicalTrials.gov Identifier:
NCT00180427
First received: September 12, 2005
Last updated: April 22, 2008
Last verified: April 2008
  Purpose

"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."


Condition Intervention Phase
Ventricular Fibrillation
Device: ICD
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: VERRARI - "Are Ventricular Arrhythmic Episodes Reduced by Rate Response in ICDs?"

Resource links provided by NLM:


Further study details as provided by Guidant Corporation:

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,

Estimated Enrollment: 75
Study Start Date: June 2001
Study Completion Date: November 2004
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."

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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"
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00180427

Locations
Germany
Medizinische Klinik der Medizinischen Hochschule
Hannover, Germany
Sponsors and Collaborators
Guidant Corporation
Investigators
Principal Investigator: Michael Niehaus, MD Hannover Medical School
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00180427     History of Changes
Other Study ID Numbers: Version vom 01.03.2001
Study First Received: September 12, 2005
Last Updated: April 22, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Ventricular Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 20, 2014