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

NCT00324662 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2008-09-30

No results posted yet for this study

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.

Conditions

  • Tachyarrhythmia

Interventions

DEVICE

Implantable cardioverter-defibrillator

Sponsors & Collaborators

  • Biotronik SE & Co. KG

    lead INDUSTRY

Principal Investigators

  • Michael Niehaus, Prof. Dr. Med. · Medizinische Hochschule Hannover, Abt. Kardiologie, Carl-Neuberg-Str. 1, 30625 Hannover, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-08-31
Primary Completion
2008-07-31
Completion
2008-07-31

Countries

  • Germany
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00324662 on ClinicalTrials.gov