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

Ventricular Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00180427
• Other study ID #: Version vom 01.03.2001
• Status: Completed
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: April 22, 2008
• Start date: June 2001
• Est. completion date: November 2004

Study information

• Verified date: April 2008
• Source: Guidant Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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."

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."

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: November 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Ventricular Fibrillation

Intervention

Device:
• ICD

Locations

Country	Name	City	State
Germany	Medizinische Klinik der Medizinischen Hochschule	Hannover

Sponsors (1)

Lead Sponsor	Collaborator
Guidant Corporation

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	frequency of ventricular arrhythmias at 6 and 12 months follow ups
Secondary	medication, anamnesis, quality of life, 6 min walktest, echocardiographic parameters and optionally spiroergomatry at 6 and 12 months follow ups,