Status:
RECRUITING
The AFteR Registry - Follow-up Study to Monitor the Efficacy and Safety of the Occlutech AFR in Heart Failure Patients
Lead Sponsor:
Occlutech International AB
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Brief Summary
This study aims to monitor the safety and efficacy of Occlutech AFR device in patients with Heart Failure.
Detailed Description
This is a prospective, multicentre, international, follow-up registry to monitor the safety and the performance of the Occlutech AFR device in patients with Heart Failure, to identify unknown side eff...
Eligibility Criteria
Inclusion
- Written, informed consent
- Age ≥18 years
- Presence of chronic symptomatic HF (NYHA class ≥ 2)
- Left Atrial Pressure (LAP) \> Right Atrial Pressure (RAP); with a gradient equal or more than 5 mmHg\*
- LVEF ≥ 15%. If LVEF is \>40% (HFpEF), BMI corrected\*\* NT-pro-BNP must be elevated ≥ 125 pg/mL. (BNP \>35 pg/mL) or ≥ 365pg/ml (BNP \> 105 pg/mL) for patients with atrial fibrillation (AF)
- Stable guideline directed treatment according to latest applicable ESC guidelines for respective HF phenotypes for at least 1 months prior to informed consent
Exclusion
- Life expectancy \< 1 year, or advanced heart failure defined as ACC/AHA Stage D heart failure, or listed for heart transplantation at time of baseline visit
- Evidence of right heart failure defined (by ECHO) as:
- Severe Right Ventricular Dysfunction (TAPSE \< 14 mm)
- Severe Right Ventricular Dilatation (RV volume ≥ LV volume)
- Severe pulmonary hypertension (PASP \> 60 mm Hg)
- Echocardiographic evidence of intra-cardia mass, thrombus or vegetation
- Uncontrolled hypertension, Systolic Blood Pressure of \>160 mmHg or Diastolic Blood Pressure ≥ 100mmHg, despite medical therapy at the time of screening visit.
- Uncontrolled atrial fibrillation with resting heart rate \>110bpm, despite medical therapy
- Documented history of specific cardiomyopathy (obstructive hypertrophic, restrictive, infiltrative) or pericardial disease
- Congenital heart defect that interferes with placement of the device, at the discretion of the Investigator.
- Previous interventional or surgical atrial septal defect (ASD) or patent foramen ovale (PFO) closure interfering with the placement of the device
- Current atrial septal defect, or anatomical anomaly (including \> 10 mm atrial septal thickness or atrial septal aneurysm) on ECHO that precludes implantation of the device across the fossa ovalis (FO) of the interatrial septum
- Clinically significant valvular heart disease:
- regurgitation grade ≥3+ or
- severe stenosis of mitral or tricuspid valves, or
- significant stenosis of aortic valves
- Prior diagnosis of primary pulmonary hypertension
- Severe Chronic Obstructive Pulmonary Disease (COPD) requiring oral steroid therapy or oxygen administration
- History of stroke, transient ischemic attack (TIA), deep vein thrombosis (DVT), or pulmonary emboli within 6 months, or any prior stroke with persistent neurologic deficit, or any prior intracranial bleed, or known intracerebral aneurysm, AV malformation or other intracranial pathology increasing the risk of bleeding
- Myocardial Infarction (MI) and/or coronary heart disease with indication for a coronary intervention or Coronary Artery Bypass Grafting (CABG) or within 2 months prior to informed consent.
- ICD or right sided pacemaker placement within 2 months
- Clinically significant coagulation disorder, at discretion of investigator
- Patients with sepsis (local or generalized) or other acute infection(s) requiring systemic antibiotics in the two months prior enrollment
- Chronic kidney disease currently requiring dialysis
- Allergy to nickel and/or titanium and/or nickel/titanium-based materials, if not medically manageable
- Allergy to anti-platelet, anti-coagulant or anti-thrombotic therapy
- Participating in another investigational clinical trial that could interfere with this study, at the discretion of the investigator
- Other clinically significant co-morbidities that make the patient unsuitable for study participation, at the discretion of the investigator
- Note: \* LA pressure is substituted by PCW at the right heart catheterization measure while patient is awaken
- \*\*"Corrected" refers to a 4% reduction in the NT-proBNP cutoff for every increase of 1kg/m2 in body mass index (BMI) above a reference BMI of 20kg/m2)
Key Trial Info
Start Date :
October 28 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04405583
Start Date
October 28 2020
End Date
October 1 2027
Last Update
July 17 2024
Active Locations (14)
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1
CHU Besançon
Besançon, France
2
CHU Lyon
Lyon, France
3
CHU Montpellier
Montpellier, France
4
Knappschaftskrankenhaus Bottrop GmbH
Bottrop, Germany