Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:35 PM
Ignite Modification Date:
2025-12-24 @ 12:35 PM
NCT ID:
NCT00215761
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00215761
Study Brief:
Protocol Section:
NCT00215761