Ignite Creation Date:
2024-05-05 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00324662
Status:
COMPLETED
Last Update Posted:
2008-09-30
First Post:
2006-05-10
Brief Title:
Study to Verify Proper Detection of Supraventricular Tachyarrhythmia With Single-Lead Dual-Chamber Implantable Cardioverter-Defibrillators ADRIA
Sponsor:
Biotronik SE Co KG
Organization:
Biotronik SE Co KG
Study Overview
Official Title:
ADRIA - Belos A vs DR Clinical Investigation of Arrhythmia Discrimination
Status:
COMPLETED
Status Verified Date:
2008-09
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:
A unique single-lead dual-chamber implantable cardioverter-defibrillator ICD system produced by Biotronik Germany features a conventional electrode in the ventricle anchored in the ventricular apex and a floating electrode ring on the lead body in the atrium capable of sensing atrial electrical signals The purpose of this study is to determine whether this system detects a supraventricular tachyarrhythmia eg atrial fibrillation atrial tachycardia in the equivalent manner as conventional dual-lead dual-chamber ICDs using two separate electrodes anchored in the ventricle and in the atrium respectively
Detailed Description:
Supraventricular tachyarrhythmia SVT is the main cause of inappropriate therapy in patients with single-chamber implantable cardioverter-defibrillators ICDs To minimize inappropriate shock delivery ICDs should sense both atrial and ventricular intracardiac signals Dual-chamber ICDs are used for this purpose but are associated with increased postoperative complications due to the implantation of a separate atrial lead It has to be shown that a novel single-lead dual-chamber ICD-system with enhanced SVT discrimination can achieve the same specificity in discriminating SVT episodes as conventional dual-chamber ICD without the disadvantage of the implantation of several leads In this study patients eligible for dual-chamber ICD therapy who do not need atrial pacing will receive either a single-lead dual-chamber ICD Belos A and Kainox A electrode or a dual-lead dual-chamber ICD Belos DR SMART detection algorithm will be used in both study groups for discrimination between atrial and ventricular tachyarrhythmias Atrial tachyarrhythmia episodes are facultatively induced in both groups at implantation or predischarge via a bipolar stimulation catheter Induced episodes and the corresponding ICD intervention detection and therapy or inhibition of therapy are documented Follow-ups are scheduled for 1 3 6 and 12 months after implantation ICD intervention particularly related to spontaneous SVT episodes will be evaluated based on ICD diagnostic memory data interrogated at follow-up controls
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