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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-06-30

Study Completion Date

2004-11-30

Brief Summary

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"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

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"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."

Conditions

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Ventricular Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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ICD

Intervention Type DEVICE

Eligibility Criteria

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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"

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Michael Niehaus, MD

Role: PRINCIPAL_INVESTIGATOR

Hannover Medical School

Locations

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Medizinische Klinik der Medizinischen Hochschule

Hanover, , Germany

Site Status

Countries

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Germany

Other Identifiers

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Version vom 01.03.2001

Identifier Type: -

Identifier Source: org_study_id