Heart Failure Clinical Trial
— PASOfficial title:
Personalized Atrial Septostomy With Combined Use of Radiofrequency-ablation and Balloon-dilation: First-in-human Study in Heart Failure
Verified date | March 2022 |
Source | China National Center for Cardiovascular Diseases |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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. |
Country | Name | City | State |
---|---|---|---|
China | National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences,Fuwai Hospital | Beijing | Beijing |
China | Yan Chaowu | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
China National Center for Cardiovascular Diseases |
China,
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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