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:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 3:16 PM
NCT ID:
NCT07380932
Eligibility Criteria:
Inclusion Criteria:
* Patients with documented atrial fibrillation (AF).
* Transcatheter edge-to-edge mitral-valve repair (TEER) for severe functional mitral valve regurgitation (MR) with successful result (less than moderate MR, gradient \< 5 mmHg) performed within a period of minimum of 30 days and a maximum of 6 months. Moderate residual MR is eligible if no further mitral valve intervention or surgery is planned and patient is stable for \> 3 months.
* Provision of signed informed consent.
Exclusion Criteria:
* Age \<18 years
* Patient not suitable for AF ablation
* Previous ablation procedure for AF
* Acute coronary syndrome, cardiac surgery, angioplasty, or cerebrovascular accident within 2 months prior to enrolment
* Untreated hypothyroidism or hyperthyroidism requiring therapy
* Enrolment in another randomised study
* Indication for cardiac resynchronization therapy
* Current pregnancy, breastfeeding, or women not using reliable contraceptive measures during fertility age
* Mental or physical inability to participate in the study
* Planned cardiovascular intervention or operation
* Life expectancy ≤ 12 month
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07380932
Study Brief:
Protocol Section:
NCT07380932