Study to Verify Proper Detection of Supraventricular Tachyarrhythmia With Single-Lead Dual-Chamber Implantable Cardioverter-Defibrillators (ADRIA)

Tachyarrhythmia Clinical Trial

Official title:

ADRIA - Belos A+ vs DR Clinical Investigation of Arrhythmia Discrimination

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00324662
• Other study ID #: TA044
• Status: Completed
• Phase: Phase 4
• First received: May 10, 2006
• Last updated: September 29, 2008
• Start date: August 2003
• Est. completion date: July 2008

Study information

• Verified date: September 2008
• Source: Biotronik SE & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• ICD indication according to American College of Cardiology/American Heart Association (ACC/AHA) guidelines.

• Informed consent

Exclusion Criteria:

• Permanent atrial fibrillation

• Requirement for atrial pacing

• Patient is underage

• No signed patient agreement

• Patient life expectancy under 6 months

Study Design

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

Related Conditions & MeSH terms

• Tachyarrhythmia

Intervention

Device:
• Implantable cardioverter-defibrillator

Locations

Country	Name	City	State
Germany	Charité-Universitätsmedizin Campus Benjamin Franklin, Med. Klinik II / Kardiologie	Berlin
Germany	Sana Klinikum Lichtenberg	Berlin
Germany	Vivantes Netzwerk für Gesundheit GmbH (Humboldt)	Berlin
Germany	Kardiologische Praxis	Bonn
Germany	St. Johannes Hospital, Medizinische Klinik I	Dortmund
Germany	Georg-August-Universität, Universitätsklinikum Göttingen	Goettingen
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Westfälische Wilhelms-Universität	Münster
Germany	Klinikum der Stadt Villingen Schwenningen GmbH	Villingen
Switzerland	Kantonspital Basel, Abteilung für Kardiologie	Basel

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik SE & Co. KG

Countries where clinical trial is conducted

Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of correctly discriminated supraventricular tachyarrhythmia episodes (specificity)
Secondary	Complication rate (e.g. lead dislocation, lead fracture)
Secondary	Duration of implantation
Secondary	Electrode performance (P-/R-wave amplitudes, ventricular pacing threshold and impedance)
Secondary	Sensitivity (rate of correctly discriminated episodes of ventricular fibrillation or ventricular tachycardia)