Status:
COMPLETED
Pacing of the Atria in Sick Sinus Syndrome Trial Preventive Strategies for Atrial Fibrillation
Lead Sponsor:
Medtronic BRC
Collaborating Sponsors:
Vitatron GmbH
Conditions:
Sick Sinus Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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.
Detailed Description
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 re...
Eligibility Criteria
Inclusion
- Sick Sinus Syndrome
- Symptomatic sinus bradycardia
- Symptomatic SA block
- Bradycardia-Tachycardia-Syndrom
- Binodal diseases, Sinus Node Syndrome and high degree AV-Block
- In case of antiarrhythmic drug therapy: patient must be on a stable dose for at least 3 months before enrollment
Exclusion
- Permanent atrial tachycardia that cannot be transferred into sinus rhythm by drugs or electric cardioversion
- Decompensated heart failure
- Dilatative cardiomyopathy with an ejection fraction \< 35%
- Hypertrophic obstructive cardiomyopathy
- Symptomatic hypo- or hyperthyreosis
- Myocardial infarction less than 6 months ago
- Planned cardiac surgery intervention
- Pregnant woman
- Patients under 18 years of age
- Patients involved in other studies
- Patients, already implanted with other (cardiac) leads
- Patients with reduced expectancy of life due to other diseases
- Patients who are not able to agree in participation of the study
- Patients, who cannot attend follow-up visits due to their place of residence
Key Trial Info
Start Date :
July 1 2000
Trial Type :
INTERVENTIONAL
End Date :
June 1 2006
Estimated Enrollment :
456 Patients enrolled
Trial Details
Trial ID
NCT00161538
Start Date
July 1 2000
End Date
June 1 2006
Last Update
October 20 2006
Active Locations (12)
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1
Helios-Klinikum Aue
Aue, Germany, 08280
2
Klinikum Coburg
Coburg, Germany, 96450
3
Ambulantes Herz-Zentrum Dresden
Dresden, Germany, 01099
4
Werner-Forssmann-Krankenhaus GmbH
Eberswalde, Germany, 16225