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:
2025-12-25 @ 12:20 AM
Ignite Modification Date:
2025-12-25 @ 12:20 AM
NCT ID:
NCT00236158
Eligibility Criteria:
Inclusion Criteria:
General:
A. Undergoing primary pacemaker implantation B. Able to appear for outpatient follow-up C. Age \> 18 years
Symptoms:
D. Syncope or E. Dizzy spells or F. Congestive heart failure
Electrocardiographic:
G. Sinus bradycardia \<40/minute for at least 1 minute in a conscious awake state or H. Sinus arrest/sinoatrial block \>2 seconds or I. Bradycardia/tachycardia with sinus-pauses \>2 seconds
Exclusion Criteria:
Clinical:
A. Malignant disease. B. Severe psychogenic disease including severe decrepitude and dementia. C. Impending larger operation expected to influence the major end point. D. Cardiac disorder expected to need cardiac surgery during the follow-up period.
E. Need for other device implantation: ICD (implantable cardioverter defibrillator) or implantable DC converter (for atrial fibrillation).
F. Carotid sinus syndrome (positive carotid sinus massage with pauses \>3 seconds).
Electrocardiographic:
G. Atrioventricular block. H. Bundle-branch block (complete RBBB, LBBB, bifascicular bundle-branch block or non-specific intraventricular block with QRS \>0.12 seconds).
I. Chronic atrial fibrillation. J. Atrial fibrillation/atrial flutter with QRS pauses \>3 seconds during atrial fibrillation.
K. Atrial fibrillation/atrial flutter with QRS frequency \<40/minute for 1 minute.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00236158
Study Brief:
Protocol Section:
NCT00236158