Congenital heart disease
Conditions
Interventions
Innovative Combined Surgery:An innovative combined surgical strategy is employed. For enrolled patients, if the right atrial volume index (RVi) = 166.64 ml/m^2, corrective surgery plus surgical ablati
otherwise, prophylactic surgical ablation (pulmonary vein isolation + tricuspid isthmus line) is performed.
Traditional Surgery:he conventional surgical strategy was adopted. Patients without persistent atrial fibrillation (AF) or atrial flutter (AFL) underwent corrective surgery alone, whereas those with p
Sponsors
Fuwai Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
7 Years to 110 Years
Inclusion criteria
Inclusion criteria: 1. Age >= 7 years old; 2. Critical Congenital Heart Disease (CCHD) requiring surgical intervention; 3. Have a full understanding of the operational procedures and purposes of this study, be willing to participate in this study, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Unable to undergo standardized surgical ablation or atrial plasty due to anatomical reasons, such as anomalous pulmonary venous drainage (APVD); 2. Preoperative critical condition: preoperative Left Ventricular Ejection Fraction (LVEF) < 40%, application of vasoactive drugs, and emergency surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6-month postoperative incidence of Atrial Fibrillation/Atrial Flutter; | — |
Secondary
| Measure | Time frame |
|---|---|
| 30-Day Postoperative Incidence of Adverse Events (AF/AFL/Readmission, All-Cause Mortality, Self-Discharge, Reoperation Due to Bleeding, MCS);6-month postoperative incidence of AF/AFL, stroke, and readmission;Change in Right Atrial Volume Index (?RVi); | — |
Countries
China
Contacts
Public ContactYang Keming
Fuwai Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed