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

Pulmonary Arterial Hypertension Clinical Trial

— CURB  

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 Details — Status: Recruiting

Administrative data

• NCT number: NCT03554330
• Other study ID #: 2017-GZ15
• Status: Recruiting
• Phase: N/A
• Start date: July 12, 2018
• Est. completion date: December 30, 2022

Study information

• Verified date: November 2022
• Source: China National Center for Cardiovascular Diseases
• Contact: Chaowu Yan, PhD and MD
• Phone: +8610-88322265
• Email: chaowuyan[@]163.com
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Idiopathic severe pulmonary arterial hypertension;

2. Severe pulmonary arterial hypertension associated with repaired congenital heart disease;

3. World Health Organization functional class III or IV with right heart failure refractory to medical therapy;

4. Severe syncopal symptoms;

Exclusion Criteria:

1. Mean right atrial pressure >20 mm Hg;

2. Room-air resting arterial oxygen saturation <85%;

3. Left ventricular end diastolic pressure (LVEDP) >18mm Hg;

4. Pulmonary vascular resistance >55 wood units/m2.

5. Severe right ventricular failure on cardio-respiratory support

6. The predicted one-year survival <40%;

Related Conditions & MeSH terms

• Familial Primary Pulmonary Hypertension
• Hypertension
• Pulmonary Arterial Hypertension

Intervention

Other:
• Radiofrequency catheter ablation
(1) In control group: only graded balloon atrial septostomy will be carried out and there is no radiofrequency catheter ablation. (2) In single-RFA group: after graded balloon atrial septostomy identical to control group, radiofrequency catheter ablation will be performed immediately around the rim of created inter-atrial fenestration. (3) In double-RFA group: the first step is radiofrequency catheter ablation on fossae ovalis; and then the other two steps are identical to the single-RFA group (BAS and RFA around the rim of fenestration).
• Balloon atrial septostomy
Graded balloon atrial septostomy is performed in all patients.

Locations

Country	Name	City	State
China	National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences,Fuwai Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases

Country where clinical trial is conducted

China, 

References & Publications (2)

Yan C, Wan L, Li H, Wang C, Guo T, Niu H, Li S, Yundan P, Wang L, Fang W. First in-human modified atrial septostomy combining radiofrequency ablation and balloon dilation. Heart. 2022 Oct 13;108(21):1690-1698. doi: 10.1136/heartjnl-2022-321212. — View Citation

Yan C. Is combined use of radiofrequency ablation and balloon dilation the future of interatrial communications? Expert Rev Cardiovasc Ther. 2022 Nov 3. doi: 10.1080/14779072.2022.2144233. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The size change of the fenestration created with atrial septostomy	The changes of the fenestration-size will be followed up in three different groups	12 months
Secondary	The exercise tolerance	6-min walk test	12 months
Secondary	The systemic arterial oxygen saturation	The change of systemic arterial oxygen saturation after atrial septostomy	12 months
Secondary	World Health Organization functional class	World Health Organization functional class before and after atrial septostomy	12 months