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Combined Use of Radiofrequency-ablation and Balloon-septostomy in the Creation of a Stable Inter-atrial Communication — CURB  

Pulmonary Arterial Hypertension Clinical Trial

Official title:
The Combined Use of Radiofrequency-catheter-ablation and Balloon-atrial-septostomy (CURB) in the Creation of a Stable Inter-atrial Communication:a Preliminary Study in Patients With Pulmonary Arterial Hypertension

Clinical Trial Summary

Though graded balloon-atrial-septostomy (BAS) has been accepted as an effective palliative therapy for severe pulmonary arterial hypertension, spontaneous closure of septostomy is not uncommon. Radiofrequency-catheter-ablation (RFA), which has the potential to cause irreversible damage around the rim of created inter-atrial communication, might contribute to prevent the spontaneous closure. In patients with severe pulmonary arterial hypertension, the combined use of RFA and BAS (CURB) is investigated to create a stable inter-atrial communication.

Clinical Trial Description

Balloon atrial septostomy (BAS) is an important palliative therapy in patients with refractory pulmonary arterial hypertension. However, the incidence of spontaneous closure is higher, which limits the clinical utilization of this procedure. Radiofrequency catheter ablation (RFA) has the potential to cause irreversible damage around the rim of fenestration created with BAS, which might prevent the re-adhesion of the septal remnants. In addition, RFA on fossae ovalis might reduce the elastic recoil of local tissue and contribute to create larger inter-atrial fenestration with same BAS procedure. In this study, the patients between 18 and 60 years of age who have severe pulmonary arterial hypertension associated with right heart failure refractory to medical therapy or severe syncopal symptoms may be eligible for this study (idiopathic severe pulmonary arterial hypertension or severe pulmonary arterial hypertension associated with repaired congenital heart disease). These patients will be randomized 1:1:1 to control group, single-RFA group and double-RFA group: 1. In control group: only BAS is carried out. 2. In single-RFA group: after BAS procedure identical to control group, RFA is performed immediately around the rim of created inter-atrial fenestration. 3. In double-RFA group: the first step is RFA on fossae ovalis; and then the other two steps are identical to the single-RFA group (BAS and RFA around the rim of fenestration). The immediate size of created fenestration will be determined with intra-cardiac echocardiography, and the patency and size of fenestration will be followed up for 12 months. During the period of follow up, the other evaluations will include the exercise tolerance, cardiac index, systemic arterial oxygen saturation and so on. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03554330
Study type Interventional
Source China National Center for Cardiovascular Diseases
Contact Chaowu Yan, PhD and MD
Phone +8610-88322265
Email chaowuyan@163.com
Status Recruiting
Phase N/A
Start date July 12, 2018
Completion date December 30, 2022
View Details
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