Clinical Outcomes in Fenestrated Extra-Cardiac Fontan in Low Preoperative Risk Profiles (NCT03503032) | Clinical Trial Compass
CompletedNot Applicable
Clinical Outcomes in Fenestrated Extra-Cardiac Fontan in Low Preoperative Risk Profiles
Saudi Arabia62 participantsStarted 2023-04-01
Plain-language summary
Evaluation of fenestration benefit in Extra-cardiac total cavo-pulmonary connection (Fontan procedure) in single ventricle anomaly, comparing clinical outcomes of patients with low preoperative risk profiles in prospective study
Who can participate
SexALL
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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.
What they're measuring
1
Duration of chest tube drainage
Timeframe: through study completion, an average of 1 year
Trial details
NCT IDNCT03503032
SponsorKing Faisal Specialist Hospital & Research Center