Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implantable cardioverter-defibrillator | Device |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of correctly discriminated supraventricular tachyarrhythmia episodes (specificity) |
| Measure | Description | Time Frame |
|---|---|---|
| Complication rate (e.g. lead dislocation, lead fracture) | ||
| Duration of implantation | ||
| Electrode performance (P-/R-wave amplitudes, ventricular pacing threshold and impedance) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michael Niehaus, Prof. Dr. Med. | Medizinische Hochschule Hannover, Abt. Kardiologie, Carl-Neuberg-Str. 1, 30625 Hannover, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sana Klinikum Lichtenberg | Berlin | 10365 | Germany | |||
| Charité-Universitätsmedizin Campus Benjamin Franklin, Med. Klinik II / Kardiologie |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21156772 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Sensitivity (rate of correctly discriminated episodes of ventricular fibrillation or ventricular tachycardia) |
| Berlin |
| 12200 |
| Germany |
| Vivantes Netzwerk für Gesundheit GmbH (Humboldt) | Berlin | 13437 | Germany |
| Kardiologische Praxis | Bonn | 53115 | Germany |
| St. Johannes Hospital, Medizinische Klinik I | Dortmund | 44137 | Germany |
| Georg-August-Universität, Universitätsklinikum Göttingen | Göttingen | 37099 | Germany |
| Medizinische Hochschule Hannover | Hanover | 30625 | Germany |
| Westfälische Wilhelms-Universität | Münster | 48129 | Germany |
| Klinikum der Stadt Villingen Schwenningen GmbH | Villingen | 78050 | Germany |
| Kantonspital Basel, Abteilung für Kardiologie | Basel | 4031 | Switzerland |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D017180 | Tachycardia, Ventricular |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D017147 | Defibrillators, Implantable |
| ID | Term |
|---|---|
| D047548 | Defibrillators |
| D004566 | Electrodes |
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
| D004567 | Electrodes, Implanted |
| D019736 | Prostheses and Implants |
Not provided
Not provided