Pacing of the Atria in Sick Sinus Syndrome Trial Preventive Strategies for Atrial Fibrillation
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.
Sick Sinus Syndrome
Device: Pacing leads to be implanted according randomization.
Device: Selection 9000 prevent AF an Diagnose AF
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||A Randomized, Prospective Multicenter Study to Examine the Optimal Position of the Atrial Leads for Therapy of the Sinus Node Syndrome|
- 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
- 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
|Study Start Date:||July 2000|
|Estimated Study Completion Date:||June 2006|
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:
- Free atrial wall
- right atrial appendage
- coronary sinus-os
- Dual site right atrial pacing: b) plus c).
The following primary parameters will be evaluated during the study period of 2 years after implantation:
- Amounts of AF episodes with a duration of > 48 hours
- Amounts of AF episodes with a duration of > 30 minutes
- Consultations of physicians due to AF Secondarily, AF burden, Incidence of AF in total, Quality of Life, implant duration and complications will be evaluated.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00161538
|Aue, Germany, 08280|
|Coburg, Germany, 96450|
|Ambulantes Herz-Zentrum Dresden|
|Dresden, Germany, 01099|
|Eberswalde, Germany, 16225|
|Klinikum der Joh.-Wolfgang-Goethe-Universität|
|Frankfurt, Germany, 60596|
|Städtisches Krankenhaus Friedrichshafen|
|Friedrichshafen, Germany, 88048|
|Hamburg, Germany, 20251|
|Holzminden, Germany, 37603|
|Ingolstadt, Germany, 85049|
|Evangelisches Krankenhaus Kalk GmbH|
|Köhl, Germany, 51103|
|Leer, Germany, 26789|
|Krankenhaus Maria Hilf|
|Mönchengladbach, Germany, 41063|
|Principal Investigator:||Stefan G. Spitzer, MD|