Congestive Heart Failure
Conditions
Keywords
atrial flow regulator; heart failure; interatrial shunting
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.
Interventions
DEVICEAtrial flow regulator (Occlutech® AFR device)
Atrial septostomy followed by implantation of AFR.
Sponsors
Szpitale Pomorskie Sp. z o. o.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
All eligible patients will undergo detailed screening using echocardiography, impedance cardiography and right heart catheterization prior to AFR implantation.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical improvement | 12 months | Increase in 6 minutes walk test distance |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Clinical adverse event | 12 months | Cardiac mortality |
| Pulmonary artery wedge pressure (PAWP) at rest | 30 days after AFR | Reduction of PAWP at rest |
| Clinical adverse event II | 12 months | Rehospitalization for HF decompensation |
| Pulmonary artery wedge pressure (PAWP) during handgrip test | 30 days after AFR | Reduction of PAWP during handgrip test |
| KCCQ-12 | 12 months | Kansas City Cardiomyopathy Questionnaire (KCCQ-12) |
Countries
Poland
Contacts
Primary ContactLukasz Lewicki, MD, PhD
Backup ContactMaciej Karwowski, MD
Outcome results
None listed