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 @ 9:58 PM
Ignite Modification Date:
2025-12-24 @ 9:58 PM
NCT ID:
NCT03503032
Eligibility Criteria:
Inclusion Criteria:
* This study will includeall patients referred for an elective TCPC procedure at the period of the study, who demonstrated a standard risk profile
* Preoperative evaluation consisted of ECG, transthoracic echocardiogram, and complete cardiac catheterization.
Patients with the following parameters will be eligible for enrollment in the study:
* Sinus Rhythm
* Atriovnetricular valve regurgitation not more than mild
* Aortic (neoaortic) valve regurgitation not more than mild
* Normal systolic dominant ventricle function
* Mean pulmonary artery pressure not more than 15 mmHg (measured directly or estimated by pulmonary vein wedge pressure)
* Pulmonary vascular resistance not more than 2 woods unit
* End diastolic ventricular filling pressure not more than 8 mm Hg
Patient with the following will not be eligible for inclusion:
* Patients with pulmonary artery distortion, stenosis or thrombus requiring surgical or interventional additional procedures before or during the Fontan operation.
* Pacemaker insertion before or during Fontan operation.
* Significant pulmonary arteriovenous malformations (AVMs) rendering fenestration potentially a cause of excessive cyanosis.
* Patients for whom the cardiology/cardiac surgery case conference decision is strongly in favor of fenestration for any other cause.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT03503032
Study Brief:
Protocol Section:
NCT03503032