TachyarrhythmiaPhase 4NCT00324662
Study to Verify Proper Detection of Supraventricular Tachyarrhythmia With Single-Lead Dual-Chamber Implantable Cardioverter-Defibrillators (ADRIA)
A Phase 4 study testing Implantable cardioverter-defibrillator in people with Tachyarrhythmia, run by Biotronik SE & Co. KG at 10 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tachyarrhythmia
- What is being tested?
- Implantable cardioverter-defibrillator
- Type of treatment
- Medical device
- How many people
- 260 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Aug 2003to Jul 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ICD indication according to American College of Cardiology/American Heart Association (ACC/AHA) guidelines.
- Informed consent
Who cannot join
- Permanent atrial fibrillation
- Requirement for atrial pacing
- Patient is underage
- No signed patient agreement
- Patient life expectancy under 6 months
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
Germany9 sites
Sana Klinikum Lichtenberg
Berlin, 10365
Charité-Universitätsmedizin Campus Benjamin Franklin, Med. Klinik II / Kardiologie
Berlin, 12200
Vivantes Netzwerk für Gesundheit GmbH (Humboldt)
Berlin, 13437
Kardiologische Praxis
Bonn, 53115
St. Johannes Hospital, Medizinische Klinik I
Dortmund, 44137
Georg-August-Universität, Universitätsklinikum Göttingen
Göttingen, 37099
Medizinische Hochschule Hannover
Hanover, 30625
Westfälische Wilhelms-Universität
Münster, 48129
Klinikum der Stadt Villingen Schwenningen GmbH
Villingen, 78050
Switzerland1 site
Kantonspital Basel, Abteilung für Kardiologie
Basel, 4031
About this study
Official title: ADRIA - Belos A+ vs DR Clinical Investigation of Arrhythmia Discrimination
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.
Read the 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
- Being tested
- Implantable cardioverter-defibrillator
- Keywords
- Implantable cardioverter-defibrillator, Ventricular tachyarrhythmia, Supraventricular tachyarrhythmia, Electric Countershock
- Medical subject headings
- Tachycardia, Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantable cardioverter-defibrillatorDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2006 (estimated)
- Study startAug 2003
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TachyarrhythmiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biotronik SE & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Michael Niehaus, Prof. Dr. Med., Principal investigator, Medizinische Hochschule Hannover, Abt. Kardiologie, Carl-Neuberg-Str. 1, 30625 Hannover, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00324662
- Sponsor's protocol ID
- TA044
- Status last verified
- Sep 2008
- First submitted
- 10 May 2006
- Last updated
- 30 Sep 2008
- Results posted
- No
Publications
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.
PubMed 21156772
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ADRIA - Belos A+ vs DR Clinical Investigation of Arrhythmia Discrimination
- ClinicalTrials.gov ID
- NCT00324662
- Acronym / sponsor ID
- TA044
- Conditions
- Tachyarrhythmia
- Keywords
- Implantable cardioverter-defibrillator, Ventricular tachyarrhythmia, Supraventricular tachyarrhythmia, Electric Countershock
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Biotronik SE & Co. KGIndustry (pharma, biotech, devices)
- Study start
- Aug 2003
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 11 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ICD indication according to American College of Cardiology/American Heart Association (ACC/AHA) guidelines.
- Informed consent
Key exclusion criteria (5 listed)
- Permanent atrial fibrillation
- Requirement for atrial pacing
- Patient is underage
- No signed patient agreement
- Patient life expectancy under 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implantable cardioverter-defibrillator | Device | – |
Primary outcome
Rate of correctly discriminated supraventricular tachyarrhythmia episodes (specificity)
4 secondary outcomes
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2008.
- Derived from this study: PubMed 21156772Sticherling 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Niehaus, Prof. Dr. Med. principal investigator
Medizinische Hochschule Hannover, Abt. Kardiologie, Carl-Neuberg-Str. 1, 30625 Hannover, Germany
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Implantable cardioverter-defibrillator in people with Tachyarrhythmia, run by Biotronik SE & Co. KG at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of correctly discriminated supraventricular tachyarrhythmia episodes (specificity). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00324662, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2008.