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| Name | Class |
|---|---|
| Vitatron GmbH | INDUSTRY |
The purpose of this study is to determine which of 4 lead positions is most effective for pacemaker patients with Sick Sinus Syndrome in order to avoid development of atrial fibrillation.
The incidence of Atrial Fibrillation (AF) in Sick Sinus Syndrome patients treated with pacing is quite high. As AF can cause dizziness, fatigue, thromboembolism and ischemic stroke it is clinically relevant. Due to earlier publications pacing modes and lead placement seem to influence the incidence of AF. In this study the incidence of AF will be compared between 4 different atrial lead positions:
The following primary parameters will be evaluated during the study period of 2 years after implantation:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pacing leads to be implanted according randomization. | Device | |||
| Selection 9000 prevent AF an Diagnose AF | Device |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of AF is determined via memory of the pacemaker, which is saved at every follow-up visit at 1 and 10 days after implant and further on at 3, 6, 12, 18 and 24 months after implant. | ||
| 24-Hour ECG and treadmill exercise as well as echocardiography shall be performed before implant and 6, 12 and 24 months after implant |
| Measure | Description | Time Frame |
|---|---|---|
| Treadmill exercise test as well as echocardiography shall be performed before implant and 6, 12 and 24 month after implant. | ||
| Quality of Life questionnaires are obtained before implant and 12 and 24 months after implants |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stefan G. Spitzer, MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helios-Klinikum Aue | Aue | 08280 | Germany | |||
| Klinikum Coburg |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9652562 | Background | Andersen HR, Nielsen JC, Thomsen PE, Thuesen L, Mortensen PT, Vesterlund T, Pedersen AK. Long-term follow-up of patients from a randomised trial of atrial versus ventricular pacing for sick-sinus syndrome. Lancet. 1997 Oct 25;350(9086):1210-6. doi: 10.1016/S0140-6736(97)03425-9. | |
| 3394616 | Background | Rosenqvist M, Brandt J, Schuller H. Long-term pacing in sinus node disease: effects of stimulation mode on cardiovascular morbidity and mortality. Am Heart J. 1988 Jul;116(1 Pt 1):16-22. doi: 10.1016/0002-8703(88)90244-x. |
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| Coburg |
| 96450 |
| Germany |
| Ambulantes Herz-Zentrum Dresden | Dresden | 01099 | Germany |
| Werner-Forssmann-Krankenhaus GmbH | Eberswalde | 16225 | Germany |
| Klinikum der Joh.-Wolfgang-Goethe-Universität | Frankfurt | 60596 | Germany |
| Städtisches Krankenhaus Friedrichshafen | Friedrichshafen | 88048 | Germany |
| Universitätskrankenhaus Eppendorf | Hamburg | 20251 | Germany |
| Evang. Krankenhaus | Holzminden | 37603 | Germany |
| Klinikum Ingolstadt | Ingolstadt | 85049 | Germany |
| Evangelisches Krankenhaus Kalk GmbH | Köhl | 51103 | Germany |
| Kreiskrankenhaus Leer | Leer | 26789 | Germany |
| Krankenhaus Maria Hilf | Mönchengladbach | 41063 | Germany |
| 9120152 | Background | Prakash A, Saksena S, Hill M, Krol RB, Munsif AN, Giorgberidze I, Mathew P, Mehra R. Acute effects of dual-site right atrial pacing in patients with spontaneous and inducible atrial flutter and fibrillation. J Am Coll Cardiol. 1997 Apr;29(5):1007-14. doi: 10.1016/s0735-1097(97)00043-0. |
| ID | Term |
|---|---|
| D012804 | Sick Sinus Syndrome |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001146 | Arrhythmia, Sinus |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D006327 | Heart Block |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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