NCT00324662

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
260

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2003

Longer than P75 for phase_4

Geographic Reach
2 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

May 10, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 11, 2006

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

September 30, 2008

Status Verified

September 1, 2008

Enrollment Period

4.9 years

First QC Date

May 10, 2006

Last Update Submit

September 29, 2008

Conditions

Tachyarrhythmia

Keywords

Implantable cardioverter-defibrillatorVentricular tachyarrhythmiaSupraventricular tachyarrhythmiaElectric Countershock

Outcome Measures

Primary Outcomes (1)

  • Rate of correctly discriminated supraventricular tachyarrhythmia episodes (specificity)

Secondary Outcomes (4)

  • 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)

Interventions

Implantable cardioverter-defibrillatorDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ICD indication according to American College of Cardiology/American Heart Association (ACC/AHA) guidelines.
  • Informed consent

You may not qualify if:

  • Permanent atrial fibrillation
  • Requirement for atrial pacing
  • Patient is underage
  • No signed patient agreement
  • Patient life expectancy under 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Sana Klinikum Lichtenberg

Berlin, 10365, Germany

Location

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

Berlin, 12200, Germany

Location

Vivantes Netzwerk für Gesundheit GmbH (Humboldt)

Berlin, 13437, Germany

Location

Kardiologische Praxis

Bonn, 53115, Germany

Location

St. Johannes Hospital, Medizinische Klinik I

Dortmund, 44137, Germany

Location

Georg-August-Universität, Universitätsklinikum Göttingen

Göttingen, 37099, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Westfälische Wilhelms-Universität

Münster, 48129, Germany

Location

Klinikum der Stadt Villingen Schwenningen GmbH

Villingen, 78050, Germany

Location

Kantonspital Basel, Abteilung für Kardiologie

Basel, 4031, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 21156772DERIVED

MeSH Terms

Conditions

TachycardiaTachycardia, Ventricular

Interventions

Defibrillators, Implantable

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DefibrillatorsElectrodesElectrical Equipment and SuppliesEquipment and SuppliesElectrodes, ImplantedProstheses and Implants

Study Officials

  • Michael Niehaus, Prof. Dr. Med.

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 10, 2006

First Posted

May 11, 2006

Study Start

August 1, 2003

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

September 30, 2008

Record last verified: 2008-09

Locations

DE(9)CH(1)