Clinical Trials Logo

Clinical Trial 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 (e.g. 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.


Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00324662
Study type Interventional
Source Biotronik SE & Co. KG
Contact
Status Completed
Phase Phase 4
Start date August 2003
Completion date July 2008

See also
  Status Clinical Trial Phase
Completed NCT02849769 - Magnetic Resonance (MR) Conditional Tachyarrhythmia Therapy Products Post-approval Study
Completed NCT02565238 - BIO.MASTER.BioMonitor 2 Study N/A
Completed NCT04025710 - Master Study of the BIOMONITOR III and Incision and Insertion Tool (FIT OneStep) N/A
Active, not recruiting NCT05621187 - Post Market Clinical Follow-up Study for the Pamira ICD Lead Family N/A
Not yet recruiting NCT06382207 - Effectiveness of the Eko Digital Stethoscope in Capturing Infant ECGs N/A
Active, not recruiting NCT01526629 - Full Automaticity and Remote Follow-up N/A
Completed NCT03850327 - BIO|CONCEPT.BIOMONITOR III N/A
Recruiting NCT04905199 - Temporary Transvenous Pacemaker Placement by Intracavitary Electrocardiogram Monitoring
Completed NCT03408951 - Surface ECG Signal Recording for the Implantable Subcutaneous String Defibrillator (ISSD) Detection Algorithm Performance Assessment
Not yet recruiting NCT06327425 - MCG for Localization of Tachyarrhythmia's Origin N/A
Recruiting NCT04863664 - Lead EvaluAtion for Defibrillation and Reliability (LEADR) / Lead Evaluation for Defibrillation and Reliability in Left Bundle Branch Area Pacing (LEADR LBBAP) N/A
Not yet recruiting NCT05750108 - Transcutaneous Vagal Nerve Stimulation to Prevent Tachyarrhythmias in Patients Early Following Myocardial Infarction N/A
Completed NCT02774616 - BIO|MASTER.Ilivia Family / Plexa N/A
Completed NCT00231426 - ASSURE Study - Arrhythmia Single Shock DFT Versus ULV: Risk Reduction Evaluation With ICD Implantations Phase 4
Completed NCT02181686 - Iperia/Sentus QP Study N/A
Terminated NCT03451227 - Dexmedetomidine and Fentanyl Versus Midazolam and Remifentanil for Sedation in Patients Undergoing Ablation Procedures N/A
Completed NCT02933619 - ProMRI ICD/CRT-D Post Approval Study
Completed NCT00170274 - APART: Prevention and Automatic Therapy of Atrial Arrhythmias in Patients With Paroxysmal Supraventricular Tachycardias N/A
Completed NCT03891329 - Master Study of the Acticor/Rivacor ICDs/CRT-Ds and the Plexa ProMRI S DX Lead N/A
Completed NCT06323499 - Outcome of Induced Atypical Atrial Flutter