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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00324662
Recruitment Status : Completed
First Posted : May 11, 2006
Last Update Posted : September 30, 2008
Information provided by:
Biotronik SE & Co. KG

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.

Condition or disease Intervention/treatment Phase
Tachyarrhythmia Device: Implantable cardioverter-defibrillator Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ADRIA - Belos A+ vs DR Clinical Investigation of Arrhythmia Discrimination
Study Start Date : August 2003
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Rate of correctly discriminated supraventricular tachyarrhythmia episodes (specificity)

Secondary Outcome Measures :
  1. Complication rate (e.g. lead dislocation, lead fracture)
  2. Duration of implantation
  3. Electrode performance (P-/R-wave amplitudes, ventricular pacing threshold and impedance)
  4. Sensitivity (rate of correctly discriminated episodes of ventricular fibrillation or ventricular tachycardia)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00324662

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Sana Klinikum Lichtenberg
Berlin, Germany, 10365
Charité-Universitätsmedizin Campus Benjamin Franklin, Med. Klinik II / Kardiologie
Berlin, Germany, 12200
Vivantes Netzwerk für Gesundheit GmbH (Humboldt)
Berlin, Germany, 13437
Kardiologische Praxis
Bonn, Germany, 53115
St. Johannes Hospital, Medizinische Klinik I
Dortmund, Germany, 44137
Georg-August-Universität, Universitätsklinikum Göttingen
Goettingen, Germany, 37099
Medizinische Hochschule Hannover
Hannover, Germany, 30625
Westfälische Wilhelms-Universität
Münster, Germany, 48129
Klinikum der Stadt Villingen Schwenningen GmbH
Villingen, Germany, 78050
Kantonspital Basel, Abteilung für Kardiologie
Basel, Switzerland, 4031
Sponsors and Collaborators
Biotronik SE & Co. KG
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Principal Investigator: Michael Niehaus, Prof. Dr. Med. Medizinische Hochschule Hannover, Abt. Kardiologie, Carl-Neuberg-Str. 1, 30625 Hannover, Germany
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00324662    
Other Study ID Numbers: TA044
First Posted: May 11, 2006    Key Record Dates
Last Update Posted: September 30, 2008
Last Verified: September 2008
Keywords provided by Biotronik SE & Co. KG:
Implantable cardioverter-defibrillator
Ventricular tachyarrhythmia
Supraventricular tachyarrhythmia
Electric Countershock
Additional relevant MeSH terms:
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Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes