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 @ 5:59 PM
Ignite Modification Date:
2025-12-24 @ 5:59 PM
NCT ID:
NCT02085668
Eligibility Criteria:
Inclusion Criteria:
* New York Heart Association Class II-III symptoms of chronic heart failure
* Systolic left ventricular dysfunction as assessed by echocardiogram with left ventricular ejection fraction in a range of 10%- 40%.
* GFR \>30 mL/min/1.73m2
* Brain natriuretic Peptide (BNP) \>100 pg/ml or N terminal (NT)-Pro-BNP \>400 pg/ml.
* Optimal medical therapy according to current guidelines for CHF management. Treatment for HF must be stable (including drug and dose) for at least 4 weeks prior to procedure, with the exception of diuretics, where stability is required for at least 2 weeks.
* others
Exclusion Criteria:
* Renal arterial anatomy that is ineligible for treatment
* CHF caused by pericarditis or by acute myocarditis or by endocrine diseases.
* Myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within three 12 weeks of the screening visit.
* Office systolic BP at screening less than 90 mmHg
* Primary pulmonary hypertension.
* Clinically significant cardiac structural valvular disease, unless corrected by a properly functional prosthetic valve
* Major surgery, including bariatric surgery, in the previous 12 weeks before baseline.
* Contrast media administration in the previous 30 days before baseline.
* Known hypersensitivity to material of the Symplicity Catheter.
* Inpatient hospitalization for decompensated HF in the previous 60 days before baseline.
* others
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02085668
Study Brief:
Protocol Section:
NCT02085668