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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 60 Years
Gender	All

More Inclusion & Exclusion Criteria

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%;

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03554330
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	China National Center for Cardiovascular Diseases
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Chaowu Yan, PhD and MD
Principal Investigator Affiliation	National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences,Fuwai Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Pulmonary Arterial Hypertension

Additional Details

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.

Arms & Interventions

Arms

Active Comparator: control group

Only graded balloon atrial septostomy is carried out, and no radiofrequency catheter ablation is performed.

Experimental: single-RFA group

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.

Experimental: 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 (graded balloon atrial septostomy and radiofrequency catheter ablation around the rim of fenestration).

Interventions

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).

Other: - Balloon atrial septostomy

Graded balloon atrial septostomy is performed in all patients.

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