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 @ 3:01 AM
Ignite Modification Date:
2025-12-25 @ 3:01 AM
NCT ID:
NCT05760833
Eligibility Criteria:
Inclusion Criteria:
* Presence of a cardiac resynchronization therapy device (CRT-D or CRT-P) and optimal medical therapy according to current guidelines.
* Patients with paroxysmal or persistent AF, having AF or HF related symptoms.
* Patient with paroxysmal AF should have \>25% burden or inadequate biventricular pacing (\<95%) based on device counters.
* The patient is willing and able to comply with the protocol and has provided written informed consent.
* Age ≥ 18 years
Exclusion Criteria:
* Documented left atrial diameter \> 6 cm (parasternal long axis).
* Longstanding persistent AF longer than 2 years.
* Contraindication to chronic anticoagulation therapy or heparin
* Previous left heart ablation procedure for AF
* Acute coronary syndrome, cardiac surgery, angioplasty or stroke within 2 months prior to enrolment
* Untreated hypothyroidism or hyperthyroidism
* Enrolment in another investigational drug or device study.
* Woman currently pregnant or breastfeeding or not using reliable contraceptive measures during fertility age.
* Mental or physical inability to participate in the study.
* Listed for heart transplant.
* Cardiac assist device implanted.
* Planned cardiovascular intervention.
* Life expectancy ≤ 12 months.
* Uncontrolled hypertension.
* Requirement for dialysis due to terminal renal failure.
* Participation in another telemonitoring concept
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05760833
Study Brief:
Protocol Section:
NCT05760833