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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04573166
Other study ID # 2020-8
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date September 25, 2020
Est. completion date January 1, 2025

Study information

Verified date March 2022
Source China National Center for Cardiovascular Diseases
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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).


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 30
Est. completion date January 1, 2025
Est. primary completion date January 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: 1. Age =18 years; 2. Symptomatic heart failure in NYHA class III or IV ambulatory; 3. Optimal medical therapy of heart failure according to European Society of Cardiology (ESC) guidelines for last 6 months; 4. LVEF = 45%; 5. Elevated left heart filling pressures: left ventricular end-diastolic pressure (LVEDP) or pulmonary capillary wedge pressure (PCWP) = 18 mmHg at rest; 6. LVEDP or PCWP-Mean right atrial pressure (MRAP) = 5 mmHg; 7. Systolic blood pressure = 90 mmHg. Exclusion Criteria: 1. Acute infection or sepsis; 2. Intra-cardiac mass, thrombus or vegetation; 3. Evidence of right heart failure (TAPSE < 14 mm); 4. Pulmonary hypertension (PASP > 60 mmHg); 5. Associated atrial septal defect or large patent foramen ovale with significant left to right shunt in rest; 6. TIA or stroke within the last 6 months; 7. Thromboembolic events within the last 6 months; 8. Hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy as cause of heart failure; 9. Valvular diseases requiring therapy according to current ESC guidelines; 10. Life expectancy < 1 year for non-cardiovascular reasons.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Personalized atrial septostomy with combined use of radiofrequency-ablation and balloon-dilation
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.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
China National Center for Cardiovascular Diseases

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical change Distance in 6 minutes walk test 12 months
Primary The size of created-fenestration The change of created-fenestration size evaluated with echocardiography 12 months
Secondary 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. 12 months
Secondary Change of PAWP or MLAP at rest Pulmonary capillary wedge pressure (PCWP)/MLAP at rest evaluated with right heart catheterization 12 months
Secondary Change of cardiac remodeling The change in cardiac chamber and function evaluated with MSCT and CMR 12 months
Secondary Myocardial remodeling The myocardial molecular imaging evaluated with PET-CT 12 months
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