Atrial Flow Regulator in Heart Failure

Not Applicable

• Conditions: Congestive Heart Failure
• Interventions: Device: Atrial flow regulator (Occlutech® AFR device)

• Registration Number: NCT04334694
• Lead Sponsor: Szpitale Pomorskie Sp. z o. o.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-07
• Status Verified: 2020-04
• Study First Submitted: 2020-04-02
• Study First Submitted QC: 2020-04-02
• Last Update Submitted: 2020-04-02
• Study First Posted: 2020-04-06
• Last Update Posted: 2020-04-06
• Primary Completion: 2022-01
• Study Completion: 2022-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Clinical improvement	12 months	Increase in 6 minutes walk test distance

Secondary Outcome Measures

Name	Time	Method
Clinical improvement II	12 months	Reduction in New York Heart Association (NYHA) class
Device related adverse event	12 months	Device migration, embolization, device related thrombus, shunt occlusion, need for device removal

Trial Locations

Locations (1)

Kashubian Cardiovascular Center; 🇵🇱 Wejherowo, Poland