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 @ 4:12 PM
Ignite Modification Date:
2025-12-24 @ 4:12 PM
NCT ID:
NCT02909166
Eligibility Criteria:
Inclusion Criteria:
* age between 18 and 85 years
* sinus node disease and paroxysmal AF
* provided signed informed consent according to the Declaration of Helsinki for study participation
* a previously implanted St. Jude Medical Identity / Victory / Zephyr ADX or any newer model of SJM DDDR pacemaker with ability to record high atrial rates
Exclusion Criteria:
* contraindication for the use of aliskiren
* severe impairment of renal function (serum creatinine \> 160 µmol/L) or patient with solitary kidney or renal transplant or renal artery stenosis
* significant known aortic or mitral valve stenosis or obstructive hypertrophic cardiomyopathy
* hypersensitivity to aliskiren or to any of the excipients
* concomitant treatment with cyclosporine
* patients with uncontrolled hypertension requiring treatment for hypertension
* systolic blood pressure measured in two separate occasions ≥ 160 mmHg
* diastolic blood pressure in two separate occasions ≥ 100 mmHg
* absolute indication for the use of an RAAS blocker
* chronic, persisting AF (persisting AF at screening with ≥ 4 cardioversions performed beforehand)
* sitting systolic arterial blood pressure of less than 100 mm Hg at the time of randomisation
* need for ventricular pacing more than 30% at the enrolment
* pregnancy and/or lactation
* women of childbearing potential (only postmenopausal women or women after tubal ligation will be allowed)
* other serious disease expected to cause substantial deterioration of patient's health during the next two years
* past or present alcohol or drug abuse
* participation in other clinical trials during the last three months
* suspicion of poor study compliance
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT02909166
Study Brief:
Protocol Section:
NCT02909166