Pulmonary Arterial HypertensionCURBNCT03554330
Combined Use of Radiofrequency-ablation and Balloon-septostomy in the Creation of a Stable Inter-atrial Communication
A study testing Radiofrequency catheter ablation and Balloon atrial septostomy in people with Pulmonary Arterial Hypertension, run by China National Center for Cardiovascular Diseases at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- Radiofrequency catheter ablation and Balloon atrial septostomy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 12 Jul 2018to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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;
Who cannot join
- 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%;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences,Fuwai Hospital
Beijing, Beijing Municipality, 100037
Chaowu Yan, PhD and MD
About this study
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
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.
Read the detailed 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:
- In control group: only BAS is carried out.
- In single-RFA group: after BAS procedure identical to control group, RFA is performed immediately around the rim of created inter-atrial fenestration.
- 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.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- Radiofrequency catheter ablation, Balloon atrial septostomy
- Keywords
- pulmonary arterial hypertension, balloon atrial septostomy, radiofrequency catheter ablation, spontaneous closure
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency catheter ablationOther
(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 septostomyOther
Graded balloon atrial septostomy is performed in all patients.
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | Only graded balloon atrial septostomy is carried out, and no radiofrequency catheter ablation is performed. Receives: Other: Balloon atrial septostomy |
| single-RFA group | Experimental | 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. Receives: Other: Radiofrequency catheter ablation; Other: Balloon atrial septostomy |
| double-RFA group | Experimental | 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). Receives: Other: Radiofrequency catheter ablation; Other: Balloon atrial septostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The size change of the fenestration created with atrial septostomy
The changes of the fenestration-size will be followed up in three different groups
Measured: 12 months
Secondary outcomes (3)
The exercise tolerance
6-min walk test
Measured: 12 months
The systemic arterial oxygen saturation
The change of systemic arterial oxygen saturation after atrial septostomy
Measured: 12 months
World Health Organization functional class
World Health Organization functional class before and after atrial septostomy
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2018
- Study start12 Jul 2018
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Chaowu Yan, PhD and MD, Principal investigator, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences,Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03554330
- Sponsor's protocol ID
- 2017-GZ15
- Acronym
- CURB
- Status last verified
- Nov 2022
- First submitted
- 31 May 2018
- Last updated
- 16 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35676068Yan 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.
PubMed 36329641
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03554330
- Acronym / sponsor ID
- CURB / 2017-GZ15
- Conditions
- Pulmonary Arterial Hypertension
- Keywords
- pulmonary arterial hypertension, balloon atrial septostomy, radiofrequency catheter ablation, spontaneous closure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 12 Jul 2018 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 13 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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:
- In control group: only BAS is carried out.
- In single-RFA group: after BAS procedure identical to control group, RFA is performed immediately around the rim of created inter-atrial fenestration.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Other: Balloon atrial septostomyOnly graded balloon atrial septostomy is carried out, and no radiofrequency catheter ablation is performed. |
| single-RFA group | Experimental | Other: Radiofrequency catheter ablation, Other: Balloon atrial septostomyAfter 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 | Experimental | Other: Radiofrequency catheter ablation, Other: Balloon atrial septostomyThe 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). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | double-RFA group, single-RFA group |
| Balloon atrial septostomyGraded balloon atrial septostomy is performed in all patients. | Other | control group, double-RFA group, single-RFA group |
Primary outcome
The size change of the fenestration created with atrial septostomy
Time frame: 12 months
The changes of the fenestration-size will be followed up in three different groups
3 secondary outcomes
The exercise tolerance
Time frame: 12 months
The systemic arterial oxygen saturation
Time frame: 12 months
World Health Organization functional class
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2022.
- Results publication: PubMed 35676068Yan 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.
- Results publication: PubMed 36329641Yan 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.
- Individual participant dataSharing planned: Undecided
Related trials for Pulmonary Arterial Hypertension
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Pilot Study of Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in Pulmonary Arterial Hypertension (GUT RESTORE-PAH)
Pulmonary Arterial Hypertension
RecruitingObservational study
Natural History Study of Biomarkers in Pulmonary Arterial Hypertension
Pulmonary Disease, Pulmonary Hypertension
Active, not recruitingPhase 1
Study of Intravenous ZMA001 in Healthy Subjects
Pulmonary Arterial Hypertension PAH
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chaowu Yan, PhD and MD principal investigator
National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences,Fuwai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency catheter ablation and Balloon atrial septostomy in people with Pulmonary Arterial Hypertension, run by China National Center for Cardiovascular Diseases at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chaowu Yan, PhD and MD (+8610-88322265, chaowuyan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The size change of the fenestration created with atrial septostomy (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03554330, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2022.