Combined Use of Radiofrequency-ablation and Balloon-septostomy in the Creation of a Stable Inter-atrial Communication (CURB)
Pulmonary Arterial Hypertension
About this trial
This is an interventional treatment trial for Pulmonary Arterial Hypertension focused on measuring pulmonary arterial hypertension, balloon atrial septostomy, radiofrequency catheter ablation, spontaneous closure
Eligibility Criteria
Inclusion Criteria:
- Idiopathic severe pulmonary arterial hypertension;
- Severe pulmonary arterial hypertension associated with repaired congenital heart disease;
- World Health Organization functional class III or IV with right heart failure refractory to medical therapy;
- Severe syncopal symptoms;
Exclusion Criteria:
- Mean right atrial pressure >20 mm Hg;
- Room-air resting arterial oxygen saturation <85%;
- Left ventricular end diastolic pressure (LVEDP) >18mm Hg;
- Pulmonary vascular resistance >55 wood units/m2.
- Severe right ventricular failure on cardio-respiratory support
- The predicted one-year survival <40%;
Sites / Locations
- National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences,Fuwai HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Experimental
Experimental
control group
single-RFA group
double-RFA group
Only graded balloon atrial septostomy is carried out, and no radiofrequency catheter ablation is performed.
After graded balloon atrial septostomy procedure identical to control group, radiofrequency catheter ablation will be performed immediately around the rim of created inter-atrial fenestration.
The first step is radiofrequency catheter ablation on fossae ovalis; and then the other two steps are identical to the single-RFA group (graded balloon atrial septostomy and radiofrequency catheter ablation around the rim of fenestration).