search
Back to results

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
Guidant Corporation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ventricular Fibrillation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
September 12, 2005
Last Updated
April 22, 2008
Sponsor
Guidant Corporation
search

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?"

We'll reach out to this number within 24 hrs