Clinical trial NCT04334694: Atrial Flow Regulator in Heart Failure
Official title: Pomeranian atRial flOw reguLatOr iN conGestive hEart failuRe (PROLONGER) Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Congestive Heart Failure
Keywords: atrial flow regulator; heart failure; interatrial shunting
Lead sponsor: Szpitale Pomorskie Sp. z o. o.
Sponsor class: OTHER
First posted: 2020-04-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All eligible patients will undergo detailed screening using echocardiography, impedance cardiography and right heart catheterization prior to AFR implantation.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Clinical improvement
timeFrame: 12 months
Secondary outcomes:
measure: Clinical improvement II
timeFrame: 12 months
measure: Device related adverse event
timeFrame: 12 months
Other outcomes:
measure: Pulmonary artery wedge pressure (PAWP) at rest
timeFrame: 30 days after AFR
measure: Pulmonary artery wedge pressure (PAWP) during handgrip test
timeFrame: 30 days after AFR
measure: KCCQ-12
timeFrame: 12 months
measure: Clinical adverse event
timeFrame: 12 months
measure: Clinical adverse event II
timeFrame: 12 months
Locations:
city: Wejherowo
country: Poland
facility: Kashubian Cardiovascular Center
Study officials:
affiliation: Kashubian Cardiovascular Center; University Center for Cardiology
name: Lukasz Lewicki, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: