Personalized Atrial Septostomy for Heart Failure (PAS)

National Center for Cardiovascular Diseases

Status: Invitation-only

Conditions: Heart Failure, Diastolic; Heart Failure

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04573166

2020-8

Details and patient eligibility

About

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).

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

30 participants in 1 patient group

CURB procedure

Experimental group

Description:

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

Treatment:

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