Heart FailurePASNCT04573166
Personalized Atrial Septostomy for Heart Failure
A study testing Personalized atrial septostomy with combined use of radiofrequency-ablation and balloon-dilation in people with Heart Failure and Heart Failure, Diastolic, run by China National Center for Cardiovascular Diseases at 2 sites in China.
Trial summary
This study aims to investigate the safety and efficacy of personalized atrial septostomy (PAS) with combined use of radiofrequency-ablation and balloon-dilation (CURB) in heart failure with reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Heart Failure, Heart Failure, Diastolic
- What is being tested?
- Personalized atrial septostomy with combined use of radiofrequency-ablation and balloon-dilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesChina
- Study dates
- 25 Sep 2020to 1 Jan 2025
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years;
- Symptomatic heart failure in NYHA class III or IV ambulatory;
- Optimal medical therapy of heart failure according to European Society of Cardiology (ESC) guidelines for last 6 months;
- LVEF ≥ 45%;
- Elevated left heart filling pressures: left ventricular end-diastolic pressure (LVEDP) or pulmonary capillary wedge pressure (PCWP) ≥ 18 mmHg at rest;
- LVEDP or PCWP-Mean right atrial pressure (MRAP) ≥ 5 mmHg;
- Systolic blood pressure ≥ 90 mmHg.
Who cannot join
- Acute infection or sepsis;
- Intra-cardiac mass, thrombus or vegetation;
- Evidence of right heart failure (TAPSE < 14 mm);
- Pulmonary hypertension (PASP > 60 mmHg);
- Associated atrial septal defect or large patent foramen ovale with significant left to right shunt in rest;
- TIA or stroke within the last 6 months;
Show all 10Show fewer
- Thromboembolic events within the last 6 months;
- Hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy as cause of heart failure;
- Valvular diseases requiring therapy according to current ESC guidelines;
- Life expectancy < 1 year for non-cardiovascular reasons.
Trial locations and contacts
2 sites in 1 country.
China2 sites
National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences,Fuwai Hospital
Beijing, Beijing Municipality, 100037
Yan Chaowu
Beijing, Beijing Municipality, 100037
About this study
Official title: Personalized Atrial Septostomy With Combined Use of Radiofrequency-ablation and Balloon-dilation: First-in-human Study in Heart Failure
This study aims to investigate the safety and efficacy of personalized atrial septostomy (PAS) with combined use of radiofrequency-ablation and balloon-dilation (CURB) in heart failure with reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF).
Read the detailed description
Atrial septostomy is an important palliative therapy in heart failure with reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF) . Though the safety of balloon atrial septostomy (BAS) is satisfactory, the incidence of spontaneous closure is higher, which limits the clinical utilization of this procedure. The device-implantation improves the long-term patency. However, the created fenestration is limited with fixed size and it is further complicated with the potential device-related complications.
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. Therefore, the combined use of radiofrequency-ablation and balloon-dilation (CURB) might become a novel procedure to create a stable inter-atrial fenestration.
In this study, the adult patients who have HFrEF and HFpEF refractory to medical therapy may be eligible for this study.
- Conditions
- Heart Failure, Heart Failure, Diastolic
- Being tested
- Personalized atrial septostomy with combined use of radiofrequency-ablation and balloon-dilation
- Keywords
- Heart failure; atrial septostomy
- Medical subject headings
- Heart Failure, Heart Failure, Diastolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized atrial septostomy with combined use of radiofrequency-ablation and balloon-dilationProcedure or surgery
After left and right catheterization, CURB procedure will be performed in all patients. The first step is RFA on fossae ovalis; and then graded BAS is carried out after transseptal puncture; finally, RFA is repeated around the fenestration-rim created with BAS. The fenestration-size will be determined based on the level of MLAP, and the immediate size of fenestration will be evaluated with intra-cardiac echocardiography. The patency and size of fenestration will be followed up for 6 months. During the period of follow up, the other evaluations will include the improvement in exercise tolerance, major adverse cardiac and/or cerebrovascular events (MACCE), reduction of PAWP/MLAP at rest, cardiac remodeling, myocardial injury, and so on.
| Study group | Role | What they receive |
|---|---|---|
| CURB procedure | Experimental | Personalized atrial septostomy with combined use of radiofrequency-ablation and balloon-dilation (CURB) Receives: Procedure: Personalized atrial septostomy with combined use of radiofrequency-ablation and balloon-dilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical change
Distance in 6 minutes walk test
Measured: 12 months
The size of created-fenestration
The change of created-fenestration size evaluated with echocardiography
Measured: 12 months
Secondary outcomes (4)
The percent of subjects who experience major adverse cardiac and cerebrovascular events (MACCE)
Peri-procedural, and 12 months MACCE and systemic embolic events in patients after CURB procedure.
Measured: 12 months
Change of PAWP or MLAP at rest
Pulmonary capillary wedge pressure (PCWP)/MLAP at rest evaluated with right heart catheterization
Measured: 12 months
Change of cardiac remodeling
The change in cardiac chamber and function evaluated with MSCT and CMR
Measured: 12 months
Myocardial remodeling
The myocardial molecular imaging evaluated with PET-CT
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 posted5 Oct 2020
- Study start25 Sep 2020
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- After left and right catheterization, CURB procedure will be performed in all patients. The first step is RFA on fossae ovalis; and then graded BAS is carried out after transseptal puncture; finally, RFA is repeated around the fenestration-rim created with BAS. The fenestration-size will be determined based on the levels of AOP and MLAP, and the immediate size of fenestration will be evaluated with intra-cardiac echocardiography. 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 improvement in exercise tolerance, major adverse cardiac and/or cerebrovascular events (MACCE), reduction of PAWP/MLAP at rest, cardiac remodeling, myocardial injury, and so on.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China National Center for Cardiovascular Diseases
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Chaowu Yan, PhD and MD, Principal investigator, National Center for Cardiovascular Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04573166
- Sponsor's protocol ID
- 2020-8
- Acronym
- PAS
- Status last verified
- Mar 2022
- First submitted
- 20 Sep 2020
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yan C, Li H, Wan L, Liu A, Yundan P, Guo T, Hua L, Wang L, Fang W. Left atrial pressure normalisation by graded radiofrequency atrial septostomy in heart failure with preserved ejection fraction: a single-arm pilot study. Heart. 2025 Oct 14;111(21):1020-1027. doi: 10.1136/heartjnl-2025-325929.
PubMed 40425275
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Atrial Septostomy With Combined Use of Radiofrequency-ablation and Balloon-dilation: First-in-human Study in Heart Failure
- ClinicalTrials.gov ID
- NCT04573166
- Acronym / sponsor ID
- PAS / 2020-8
- Conditions
- Heart Failure, Heart Failure, Diastolic
- Keywords
- Heart failure; atrial septostomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 25 Sep 2020 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 5 Oct 2020 (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.
This study aims to investigate the safety and efficacy of personalized atrial septostomy (PAS) with combined use of radiofrequency-ablation and balloon-dilation (CURB) in heart failure with reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF).
Detailed description
Atrial septostomy is an important palliative therapy in heart failure with reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF) . Though the safety of balloon atrial septostomy (BAS) is satisfactory, the incidence of spontaneous closure is higher, which limits the clinical utilization of this procedure. The device-implantation improves the long-term patency. However, the created fenestration is limited with fixed size and it is further complicated with the potential device-related complications.
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. Therefore, the combined use of radiofrequency-ablation and balloon-dilation (CURB) might become a novel procedure to create a stable inter-atrial fenestration.
In this study, the adult patients who have HFrEF and HFpEF refractory to medical therapy may be eligible for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- After left and right catheterization, CURB procedure will be performed in all patients. The first step is RFA on fossae ovalis; and then graded BAS is carried out after transseptal puncture; finally, RFA is repeated around the fenestration-rim created with BAS. The fenestration-size will be determined based on the levels of AOP and MLAP, and the immediate size of fenestration will be evaluated with intra-cardiac echocardiography. 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 improvement in exercise tolerance, major adverse cardiac and/or cerebrovascular events (MACCE), reduction of PAWP/MLAP at rest, cardiac remodeling, myocardial injury, and so on.
| Arm | Type | Receives |
|---|---|---|
| CURB procedure | Experimental | Procedure: Personalized atrial septostomy with combined use of radiofrequency-ablation and balloon-dilationPersonalized atrial septostomy with combined use of radiofrequency-ablation and balloon-dilation (CURB) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 years;
- Symptomatic heart failure in NYHA class III or IV ambulatory;
- Optimal medical therapy of heart failure according to European Society of Cardiology (ESC) guidelines for last 6 months;
- LVEF ≥ 45%;
- Elevated left heart filling pressures: left ventricular end-diastolic pressure (LVEDP) or pulmonary capillary wedge pressure (PCWP) ≥ 18 mmHg at rest;
Key exclusion criteria (10 listed)
- Acute infection or sepsis;
- Intra-cardiac mass, thrombus or vegetation;
- Evidence of right heart failure (TAPSE < 14 mm);
- Pulmonary hypertension (PASP > 60 mmHg);
- Associated atrial septal defect or large patent foramen ovale with significant left to right shunt in rest;
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 |
|---|---|---|
| Personalized atrial septostomy with combined use of radiofrequency-ablation and balloon-dilationAfter left and right catheterization, CURB procedure will be performed in all patients. The first step is RFA on fossae ovalis; and then graded BAS is carried out after transseptal puncture; finally, RFA is repeated around the fenestration-rim created with BAS. The fenestration-size will be determined based on the level of MLAP, and the immediate size of fenestration will be evaluated with intra-cardiac echocardiography. The patency and size of fenestration will be followed up for 6 months. During the period of follow up, the other evaluations will include the improvement in exercise tolerance, major adverse cardiac and/or cerebrovascular events (MACCE), reduction of PAWP/MLAP at rest, cardiac remodeling, myocardial injury, and so on. | Procedure or surgery | CURB procedure |
Primary outcome
Clinical change
Time frame: 12 months
Distance in 6 minutes walk test
The size of created-fenestration
Time frame: 12 months
The change of created-fenestration size evaluated with echocardiography
4 secondary outcomes
The percent of subjects who experience major adverse cardiac and cerebrovascular events (MACCE)
Time frame: 12 months
Change of PAWP or MLAP at rest
Time frame: 12 months
Change of cardiac remodeling
Time frame: 12 months
Myocardial remodeling
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 5 Apr 2022.
- Derived from this study: PubMed 40425275Yan C, Li H, Wan L, Liu A, Yundan P, Guo T, Hua L, Wang L, Fang W. Left atrial pressure normalisation by graded radiofrequency atrial septostomy in heart failure with preserved ejection fraction: a single-arm pilot study. Heart. 2025 Oct 14;111(21):1020-1027. doi: 10.1136/heartjnl-2025-325929.
- Individual participant dataSharing planned: No
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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized atrial septostomy with combined use of radiofrequency-ablation and balloon-dilation in people with Heart Failure and Heart Failure, Diastolic, run by China National Center for Cardiovascular Diseases at 2 sites 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 7 inclusion and 10 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 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical change (time frame: 12 months). The study lists 2 primary outcomes in all. 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 NCT04573166, which also lists 1 linked publication.
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 5 Apr 2022.