Status:
COMPLETED
Recurrence of Atrial Fibrillation in Patients With Dual-chamber Pacemakers and Drug Therapy
Lead Sponsor:
Atrial Fibrillation Network
Collaborating Sponsors:
Medtronic BRC
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Brief Summary
Comparison of AF-Burden in patients with paroxysmal atrial fibrillation and the necessity of a Dual-Chamber-Pacemaker-Therapy either with a DDD\[R\]60-Stimulation or AF prevention pacing. All Patients...
Detailed Description
Implantable pacemaker devices are available with specific atrial pacing algorithms designed to prevent atrial arrhythmias (Preventive stimulation). These algorithms work by increasing the atrial pacin...
Eligibility Criteria
Inclusion
- Paroxysmal symptomatic atrial fibrillation
- Implantation of a dual-chamber pacemaker because of generally accepted pacing indications
- Symptomatic sinus bradycardia, sinus arrest, Tachy-Brady-Syndrome
- Symptomatic sinuatrial block
- Advanced AV-block (AV block II / III)
- Binodal disease: Sick-sinus-syndrome and advanced AV-block
- AV-Nodal-Ablation in combination with pacemaker therapy ( "Ablate \& Pace").
- The implantation of a fully functional DDDR Selection 9000, Prevent AF, T 70 DR pacemaker (Vitatron) e.g. normal impedance, stimulation thresholds and sensing values) 2 - 4 months after implantation
- Written informed consent of the patient
- Age \> 18 years
Exclusion
- Chronic heart failure (NYHA III/IV)
- Acute myocardial infarction \< 6 months
- Hypertrophic obstructive cardiomyopathy
- Symptomatic hypo- or hyperthyroidism
- Instable angina pectoris
- Cardiogenic shock
- Patients with diabetes mellitus and recurrent hypoglycaemia
- Pregnancy or breast feeding
- Participation in a clinical trial within the last 30 days. Simultaneous participation in a registry (e.g. project AB1 of the AFNET) is permitted
- Reduced life expectancy (\< 6 months)
- Legal incapacity, or other circumstances which would prevent the patient from understanding the aim, nature or extent of the clinical trial
- Evidence of an uncooperative attitude
Key Trial Info
Start Date :
January 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
263 Patients enrolled
Trial Details
Trial ID
NCT00215761
Start Date
January 1 2005
End Date
December 1 2008
Last Update
September 10 2012
Active Locations (1)
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1
University Cardiac Center
Hamburg, Hamburg, Germany, 20246