Skip to main content
OpenTrials
Completed

NCT Number: NCT00180427

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."

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ventricular Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medizinische Klinik der Medizinischen Hochschule

Hanover, Germany

About this study

"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."

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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"

Treatment and study plan

ICD

Device

Primary outcomes

  1. frequency of ventricular arrhythmias at 6 and 12 months follow ups

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Guidant Corporation

Industry

Registry information

Important dates

Study start
2001
Study completion
2004
First posted
Sep 16, 2005
Registry last updated
Apr 24, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.