Personalized Atrial Septostomy for Heart Failure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-25

Study Completion Date

2025-01-01

Brief Summary

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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).

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Detailed Description

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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

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Heart Failure Heart Failure, Diastolic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CURB procedure

Personalized atrial septostomy with combined use of radiofrequency-ablation and balloon-dilation (CURB)

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No