Combined Use of Radiofrequency-ablation and Balloon-septostomy in the Creation of a Stable Inter-atrial Communication
CURB
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
1 other identifier
interventional
90
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 31, 2018
CompletedFirst Posted
Study publicly available on registry
June 13, 2018
CompletedStudy Start
First participant enrolled
July 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2022
CompletedNovember 16, 2022
November 1, 2022
4.5 years
May 31, 2018
November 11, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
The exercise tolerance
12 months
The systemic arterial oxygen saturation
12 months
World Health Organization functional class
12 months
Study Arms (3)
control group
ACTIVE COMPARATOROnly graded balloon atrial septostomy is carried out, and no radiofrequency catheter ablation is performed.
single-RFA group
EXPERIMENTALAfter graded balloon atrial septostomy procedure identical to control group, radiofrequency catheter ablation will be performed immediately around the rim of created inter-atrial fenestration.
double-RFA group
EXPERIMENTALThe 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).
Interventions
(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).
Graded balloon atrial septostomy is performed in all patients.
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- 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%;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences,Fuwai Hospital
Beijing, Beijing Municipality, 100037, China
Related 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.
PMID: 35676068RESULTYan C. Is combined use of radiofrequency ablation and balloon dilation the future of interatrial communications? Expert Rev Cardiovasc Ther. 2022 Nov;20(11):895-903. doi: 10.1080/14779072.2022.2144233. Epub 2022 Nov 10.
PMID: 36329641RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chaowu Yan, PhD and MD
National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences,Fuwai Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 31, 2018
First Posted
June 13, 2018
Study Start
July 12, 2018
Primary Completion
December 30, 2022
Study Completion
December 30, 2022
Last Updated
November 16, 2022
Record last verified: 2022-11