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

NCT ID: NCT00324662

Last Updated: 2008-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-08-31
• Study Completion Date: 2008-07-31

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.

Conditions

Tachyarrhythmia

Keywords

Implantable cardioverter-defibrillator; Ventricular tachyarrhythmia; Supraventricular tachyarrhythmia; Electric Countershock

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Implantable cardioverter-defibrillator

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biotronik SE & Co. KG

INDUSTRY

Sponsor Role: lead

Principal Investigators

Michael Niehaus, Prof. Dr. Med.

Role: PRINCIPAL_INVESTIGATOR

Medizinische Hochschule Hannover, Abt. Kardiologie, Carl-Neuberg-Str. 1, 30625 Hannover, Germany

Locations

Sana Klinikum Lichtenberg

Berlin, , Germany

Charité-Universitätsmedizin Campus Benjamin Franklin, Med. Klinik II / Kardiologie

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

Göttingen, , Germany

Medizinische Hochschule Hannover

Hanover, , Germany

Westfälische Wilhelms-Universität

Münster, , Germany

Klinikum der Stadt Villingen Schwenningen GmbH

Villingen, , Germany

Kantonspital Basel, Abteilung für Kardiologie

Basel, , Switzerland

Countries

Canada; Germany; Switzerland

References

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.

Reference Type: DERIVED

PMID: 21156772 (View on PubMed)

Other Identifiers

TA044

Identifier Type: -

Identifier Source: org_study_id