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Personalized Atrial Septostomy for Heart Failure (PAS)

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ClinicalTrials.gov Identifier: NCT04573166
Recruitment Status : Recruiting
First Posted : October 5, 2020
Last Update Posted : October 5, 2020
Sponsor:
Information provided by (Responsible Party):
China National Center for Cardiovascular Diseases

Brief 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).

Condition or disease Intervention/treatment Phase
Heart Failure Heart Failure, Diastolic Procedure: Personalized atrial septostomy with combined use of radiofrequency-ablation and balloon-dilation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Personalized Atrial Septostomy With Combined Use of Radiofrequency-ablation and Balloon-dilation: First-in-human Study in Heart Failure
Actual Study Start Date : September 25, 2020
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : January 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: CURB procedure
Personalized atrial septostomy with combined use of radiofrequency-ablation and balloon-dilation (CURB)
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.




Primary Outcome Measures :
  1. Clinical change [ Time Frame: 12 months ]
    Distance in 6 minutes walk test

  2. The size of created-fenestration [ Time Frame: 12 months ]
    The change of created-fenestration size evaluated with echocardiography


Secondary Outcome Measures :
  1. The percent of subjects who experience major adverse cardiac and cerebrovascular events (MACCE) [ Time Frame: 12 months ]
    Peri-procedural, and 12 months MACCE and systemic embolic events in patients after CURB procedure.

  2. Change of PAWP or MLAP at rest [ Time Frame: 12 months ]
    Pulmonary capillary wedge pressure (PCWP)/MLAP at rest evaluated with right heart catheterization

  3. Change of cardiac remodeling [ Time Frame: 12 months ]
    The change in cardiac chamber and function evaluated with MSCT and CMR

  4. Myocardial remodeling [ Time Frame: 12 months ]
    The myocardial molecular imaging evaluated with PET-CT



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 ≥ 15%;
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04573166


Contacts
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Contact: Chaowu Yan, PhD and MD +861088398408 chaowuyan@163.com

Locations
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China, Beijing
National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences,Fuwai Hospital Recruiting
Beijing, Beijing, China, 100037
Contact: Chaowu Yan, PhD and MD         
Yan Chaowu Recruiting
Beijing, Beijing, China, 100037
Contact: Chaowu Yan, PhD and MD    +861088398408    chaowuyan@163.com   
Principal Investigator: Chaowu Yan, PhD and MD         
Sponsors and Collaborators
China National Center for Cardiovascular Diseases
Investigators
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Principal Investigator: Chaowu Yan, PhD and MD National Center for Cardiovascular Diseases
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Responsible Party: China National Center for Cardiovascular Diseases
ClinicalTrials.gov Identifier: NCT04573166    
Other Study ID Numbers: 2020-8
First Posted: October 5, 2020    Key Record Dates
Last Update Posted: October 5, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by China National Center for Cardiovascular Diseases:
Heart failure; atrial septostomy
Additional relevant MeSH terms:
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Heart Failure
Heart Failure, Diastolic
Heart Diseases
Cardiovascular Diseases