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:
NCT02113033
Eligibility Criteria:
Inclusion Criteria:
1. Left ventricular dysfunction of ischemic or idiopathic dilated cardiomyopathy etiology, characterized by LVEF \< 40%
2. Chronic heart failure with symptoms characterized by NYHA functional class II or III at the time of enrollment despite optimal drug regimen
3. Optimal drug regimen as defined in the current European guidelines
4. Sinus rhythm, with spontaneous heart rate ≥ 60bpm at the time of enrollment
5. Signed and dated informed consent
Main Exclusion Criteria:
* Patient implanted with or eligible to cardiac pacing as per current guideline
* Risk for neck surgery in the electrode zone within a year after enrollment
* Patient with right carotid artery stenosis
* Symptomatic hypotension
* History of peptic ulcer disease or upper gastrointestinal bleeding
* Asthma, severe COPD, or severe restrictive lung disease
* Advanced Diabetes Mellitus
* Recent acute myocardial infarction, coronary artery surgery or revascularization (or already planned)
* Recent cerebro-vascular event
* Significant valvulopathy
* Advanced Renal failure
* Previous heart transplant or current LVAD device therapy
* Life expectancy \< 1 year for non-cardiac cause
* Patient included in another clinical study that could confound the results of this study
* Inability to understand the purpose of the study or to perform the procedures of the study
* Unavailability for scheduled follow-up
* Age of less than 18 years or under guardianship
* Pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02113033
Study Brief:
Protocol Section:
NCT02113033