Atrial Flow Regulator in Heart Failure (PROLONGER)

Szpitale Pomorskie Sp. z o. o.

Status: Unknown

Conditions: Congestive Heart Failure

Treatments: Device: Atrial flow regulator (Occlutech® AFR device)

Study type: Interventional

Funder types: Other

Identifiers

NCT04334694

01/2020/W

Details and patient eligibility

About

The aim of the study is to assess invasive and non-invasive parameters that may predict clinical improvement in patients with congestive heart failure after implantation of Occlutech® Atrial flow regulator (AFR) device.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years

• Symptomatic heart failure (HF) in NYHA class III or IV ambulatory

• Optimal medical therapy of HF according to European Society of Cardiology (ESC) guidelines for last 6 months

• Hospitalization because of HF decompensation in last 12 months

• Absence of significant valvular disease requiring cardiac surgery

• Life expectancy ≥ 1 year

• Written informed consent obtained from the patient

• Left ventricle ejection fraction (LVEF) ≥ 15%

• Elevated left heart filling pressures:

  1. Pulmonary artery wedge pressure (PAWP) at rest > 15 mmHg or
  2. PAWP > 25 mmHg during hand grip test

Exclusion criteria

• Participation in another clinical trial in last 30 days

• Acute infection or sepsis

• Severe coagulation disorder

• Allergy to nickel or titanium

• Severe peripheral artery disease disabling 6 minutes walk test

• Allergy to antiplatelet drugs, oral anticoagulants or heparin

• Contraindication to trans-oesophageal echocardiography (TEE)

• Pregnancy

• Atrial septal defect (ASD) or presence of atrial septal occluder

• Severe patent foramen ovale (PFO) with significant left to right shunt in rest

• Intracardiac thrombus

• Acute coronary syndrome or Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Grafting (CABG) in last 6 months

• Severe pulmonary hypertension:

  1. Right atrial pressure ≥ PAWP (measured in right heart catheterization)
  2. Right atrial pressure > 20 mmHg (measured in right heart catheterization)

• Planned heart transplantation

• Transient ischemic attack or stroke within last 6 months

• Cardiac resynchronisation therapy (CRT) within last 6 months

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Atrial flow regulator

Other group

Description:

In this arm, patients who have elevated left ventricle filling pressures get (Occlutech® AFR device) and optimal therapy for Heart failure (HF).

Treatment:

Device: Atrial flow regulator (Occlutech® AFR device)