Clinical trial NCT00324662: Study to Verify Proper Detection of Supraventricular Tachyarrhythmia With Single-Lead Dual-Chamber Implantable Cardioverter-Defibrillators (ADRIA)
Official title: ADRIA - Belos A+ vs DR Clinical Investigation of Arrhythmia Discrimination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tachyarrhythmia
Keywords: Implantable cardioverter-defibrillator
Ventricular tachyarrhythmia
Supraventricular tachyarrhythmia
Electric Countershock
Lead sponsor: Biotronik SE & Co. KG
Sponsor class: INDUSTRY
First posted: 2006-05-11
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 (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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of correctly discriminated supraventricular tachyarrhythmia episodes (specificity)
Secondary outcomes:
measure: Complication rate (e.g. lead dislocation, lead fracture)
measure: Duration of implantation
measure: Electrode performance (P-/R-wave amplitudes, ventricular pacing threshold and impedance)
measure: Sensitivity (rate of correctly discriminated episodes of ventricular fibrillation or ventricular tachycardia)
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Sana Klinikum Lichtenberg
city: Berlin
country: Germany
facility: Charité-Universitätsmedizin Campus Benjamin Franklin, Med. Klinik II / Kardiologie
city: Berlin
country: Germany
facility: Vivantes Netzwerk für Gesundheit GmbH (Humboldt)
city: Bonn
country: Germany
facility: Kardiologische Praxis
city: Dortmund
country: Germany
facility: St. Johannes Hospital, Medizinische Klinik I
city: Goettingen
country: Germany
facility: Georg-August-Universität, Universitätsklinikum Göttingen
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Münster
country: Germany
facility: Westfälische Wilhelms-Universität
city: Villingen
country: Germany
facility: Klinikum der Stadt Villingen Schwenningen GmbH
city: Basel
country: Switzerland
facility: Kantonspital Basel, Abteilung für Kardiologie
Study officials:
affiliation: Medizinische Hochschule Hannover, Abt. Kardiologie, Carl-Neuberg-Str. 1, 30625 Hannover, Germany
name: Michael Niehaus, Prof. Dr. Med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sticherling C, Zabel M, Spencker S, Meyerfeldt U, Eckardt L, Behrens S, Niehaus M; ADRIA Investigators. Comparison of a novel, single-lead atrial sensing system with a dual-chamber implantable cardioverter-defibrillator system in patients without antibradycardia pacing indications: results of a randomized study. Circ Arrhythm Electrophysiol. 2011 Feb;4(1):56-63. doi: 10.1161/CIRCEP.110.958397. Epub 2010 Dec 14.