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."

Study Overview

• Status: Completed
• Conditions: Ventricular Fibrillation
• Intervention / Treatment: Device: 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."

• Study Type: Interventional
• Enrollment: 75
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Hannover, Germany
    • Medizinische Klinik der Medizinischen Hochschule

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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"

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
frequency of ventricular arrhythmias at 6 and 12 months follow ups

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Guidant Corporation
• Investigators: Principal Investigator: Michael Niehaus, MD, Hannover Medical School

Study record dates

Study Major Dates

• Study Start: June 1, 2001
• Study Completion (Actual): November 1, 2004

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 12, 2005
• First Posted (Estimate): September 16, 2005

Study Record Updates

• Last Update Posted (Estimate): April 24, 2008
• Last Update Submitted That Met QC Criteria: April 22, 2008
• Last Verified: April 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Ventricular Fibrillation
• Other Study ID Numbers: Version vom 01.03.2001