Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00180427
Status:
COMPLETED
Last Update Posted:
2008-04-24
First Post:
2005-09-12
Brief Title:
VERRARI - Are Ventricular Arrhythmic Episodes Reduced by Rate Response in ICDs
Sponsor:
Guidant Corporation
Organization:
Guidant Corporation
Study Overview
Official Title:
VERRARI - Are Ventricular Arrhythmic Episodes Reduced by Rate Response in ICDs
Status:
COMPLETED
Status Verified Date:
2008-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 AHAACC-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
This is a prospective open-label randomized multicenter study Inclusion criteria Patients with an indication for an ICD according to the AHAACC-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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None