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 @ 4:32 AM
Ignite Modification Date:
2025-12-25 @ 4:32 AM
NCT ID:
NCT05817318
Eligibility Criteria:
Inclusion Criteria:
* Informed Consent signed by the subject
* ≥ 18 years of age
* Recurrent, paroxysmal atrial fibrillation post repeat (≥2) pulmonary vein isolation
* Documentation of atrial fibrillation ≥3 months after the last atrial fibrillation ablation procedure by a 12-lead ECG or on a rhythm strip of ≥30 seconds duration
* Either an office systolic blood pressure ≥130 mmHg at the screening visit or antihypertensive drug therapy
Exclusion Criteria:
* Persistent or permanent atrial fibrillation post pulmonary vein isolation
* Left ventricular ejection fraction \<40%
* Severe aortic or mitral valve stenosis
* Treatment with amiodaron within the last 3 months
* Mandatory treatment with class I or III antiarrhythmic drugs
* History of reflex syncope, syncope due to orthostatic hypotension or unclear syncope in the past 3 years.
* History of orthostatic hypotension
* Abnormal blood pressure fall during active standing, defined as a progressive and sustained fall in systolic blood pressure from baseline value ≥20 mmHg or diastolic blood pressure ≥10mmHg, or a decrease in systolic blood pressure to \<90 mmHg.
* Prior renal denervation
* Renal artery stent or prior renal angioplasty
* Polycystic kidney disease, unilateral kidney, or history of renal transplant
* Estimated glomerular filtration rate (eGFR) \< 50mL/min, using the CKD-EPI creatinine equation (Chronic Kidney Disease Epidemiology)
* Female of childbearing potential (age \<50 years and last menstruation within the last 12 months), who did not undergo tubal ligation, ovariectomy or hysterectomy.
* Life expectancy \<1 year
* Enrolment in interventional studies if the other study does not allow enrolment or if primary endpoint might be affected by study participation.
* Diabetes mellitus type I
* Aortic grafts
The following exclusion criteria will apply after the run-in phase of up to 3 months duration, prospectively in patients which receive a new ICM and retrospectively in patients which already have an ICM implanted:
\- Episodes of atrial fibrillation on \<6 days in the 3 months run-in phase.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05817318
Study Brief:
Protocol Section:
NCT05817318