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 @ 4:01 PM
Ignite Modification Date:
2025-12-24 @ 4:01 PM
NCT ID:
NCT02235766
Eligibility Criteria:
Inclusion Criteria:
1. NYHA class II, III and ambulatory IV with:
* QRS complex duration ≥120msec;
* Ejection fraction ≤35%.
2. Optimized medical treatment;
3. Patient in sinus rhythm;
4. Patient is willing and able to sign an informed consent form.
Exclusion Criteria:
1. Unstable angina, or acute myocardial infarction, coronary-aortic bypass graft or percutaneous transluminal coronary angioplasty within the past 3 months;
2. Cerebral vascular attacks or transient ischemic attack within the last month;
3. Chronic atrial arrhythmias, paroxysmal atrial fibrillation events;
4. Patients already implanted with an ICD or a CRT device;
5. Pacemaker dependency or ventricular pacing percentage ≥10%;
6. Valvular disease with an indication for surgical correction ≤12 months survival expectancy;
7. Mechanical right ventricular valve;
8. Patient is enrolled in or intends to participate in another clinical trial that may have an impact on the study endpoints;
9. Pregnancy or breastfeeding;
10. Previous heart transplant;
11. Refusal of study informed consent;
12. Expected lack of compliance during follow-up;
13. Patient is less than 18 years of age;
14. Patient's life expectancy is less than 6 months in the opinion of physician.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02235766
Study Brief:
Protocol Section:
NCT02235766