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

This study has been completed.
Sponsor:
Information provided by:
Biotronik SE & Co. KG
ClinicalTrials.gov Identifier:
NCT00324662
First received: May 10, 2006
Last updated: September 29, 2008
Last verified: September 2008
  Purpose

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 Intervention Phase
Tachyarrhythmia
Device: Implantable cardioverter-defibrillator
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: ADRIA - Belos A+ vs DR Clinical Investigation of Arrhythmia Discrimination

Resource links provided by NLM:


Further study details as provided by Biotronik SE & Co. KG:

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

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

Estimated Enrollment: 260
Study Start Date: August 2003
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00324662

Locations
Germany
Sana Klinikum Lichtenberg
Berlin, Germany, 10365
Vivantes Netzwerk für Gesundheit GmbH (Humboldt)
Berlin, Germany, 13437
Charité-Universitätsmedizin Campus Benjamin Franklin, Med. Klinik II / Kardiologie
Berlin, Germany, 12200
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
Switzerland
Kantonspital Basel, Abteilung für Kardiologie
Basel, Switzerland, 4031
Sponsors and Collaborators
Biotronik SE & Co. KG
Investigators
Principal Investigator: Michael Niehaus, Prof. Dr. Med. Medizinische Hochschule Hannover, Abt. Kardiologie, Carl-Neuberg-Str. 1, 30625 Hannover, Germany
  More Information

No publications provided by Biotronik SE & Co. KG

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00324662     History of Changes
Other Study ID Numbers: TA044
Study First Received: May 10, 2006
Last Updated: September 29, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Biotronik SE & Co. KG:
Implantable cardioverter-defibrillator
Ventricular tachyarrhythmia
Supraventricular tachyarrhythmia
Electric Countershock

Additional relevant MeSH terms:
Tachycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 20, 2014