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

Sponsored by:	Guidant Corporation
Information provided by:	Guidant Corporation
ClinicalTrials.gov Identifier:	NCT00180427

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 IV

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

MedlinePlus related topics: Arrhythmia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Crossover Assignment
Official Title:	VERRARI - "Are Ventricular Arrhythmic Episodes Reduced by Rate Response in ICDs?"

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

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

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

Study placed in the following topic categories:

Heart Diseases
Paroxysmal ventricular fibrillation
Ventricular Fibrillation
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009