The Prelieve Trial - Pilot Study to Assess Safety and Efficacy of a Novel Atrial Flow Regulator (AFR) in Heart Failure Patients (PRELIEVE)

• ClinicalTrials.gov Identifier: NCT03030274
• Recruitment Status: Completed
• First Posted: January 24, 2017
• Last Update Posted: September 15, 2022
• Sponsor: Occlutech International AB
• Information provided by (Responsible Party): Occlutech International AB

Tracking Information

• First Submitted Date: January 17, 2017
• First Posted Date: January 24, 2017
• Last Update Posted Date: September 15, 2022
• Actual Study Start Date: October 11, 2017
• Actual Primary Completion Date: May 1, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 23, 2017)

Serious Adverse Device Effects (SADE) within 3 month following implantation. [ Time Frame: 0-3 month ]

Incidence of Serious Adverse Device Effects (SADE) following implantation such as:

• device dislocation / embolization
• damage to the tricuspid or mitral valve caused by the device
• intractable arrhythmias caused by the device
• any circumstances that require device removal.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 15, 2017)

• Serious Adverse Device Effects (SADE) between 3-12 month following implantation [ Time Frame: 3-12 month ]
  Incidence of all Serious Adverse Device Effects (SADE) following implantation
• Device placement [ Time Frame: 0-12 month ]
  Device placement in situ
• Left to Right shunt through the AFR device [ Time Frame: 0-12 month ]
  Evidence of Left to Right shunt through the AFR device

Original Secondary Outcome Measures (submitted: January 23, 2017)

• Serious Adverse Device Effects (SADE) between 3-12 month following implantation [ Time Frame: 3-12 month ]
  Incidence of all Serious Adverse Device Effects (SADE) following implantation
• Device placement [ Time Frame: 0-12 month ]
  Device placement in situ or not in situ (as assessed by investigator)
• Left to Right shunt through the AFR device [ Time Frame: 0-12 month ]
  Evidence of Left to Right shunt through the AFR device as assessed by echocardiography and/or fluoroscopy

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Prelieve Trial - Pilot Study to Assess Safety and Efficacy of a Novel Atrial Flow Regulator (AFR) in Heart Failure Patients
• Official Title: Prospective, Non-randomized, Pilot Study to Assess Safety and Efficacy of a Novel Atrial Flow Regulator (AFR) in Heart Failure Patients With Reduced Ejection Fraction or in Heart Failure Patients With Preserved Ejection Fraction
• Brief Summary: This study aims to investigate safety and efficacy of the Occlutech® AFR device in patients with HFrEF (Heart failure with reduced ejection fraction) and HFpEF (Heart failure with preserved ejection fraction)

Detailed Description

This study will enroll subjects with HFrEF or HFpEF, until a maximum of 100 patients have undergone implantation with the Occlutech® AFR device.

Enrolled patients will be stratified according to their ejection fraction as either HFrEF (ejection fraction > 15% and <40 %) or HFpEF ( ejection Fraktion > 40 % to 70 %). It is planned to enroll at least 100 patients per stratification subgroup.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Heart Failure Low Output
• Heart Failure

Intervention

Device: Occlutech AFR device

Catheter-guided placement of an AFR device following balloon atrial septostomy.

Study Arms

Experimental: Occlutech AFR Device

Prospective, non-randomized, pilot study to assess safety and efficacy of a novel Atrial Flow Regulator in Heart Failure Patients with with reduced Ejection Fraction (HFrEF) and Heart Failure Patients with preserved Ejection Fraction (HFpEF); the AFR-Prelieve Trial

Intervention: Device: Occlutech AFR device

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 6, 2021): 106
• Original Estimated Enrollment (submitted: January 23, 2017): 30
• Actual Study Completion Date: March 2, 2022
• Actual Primary Completion Date: May 1, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion criteria. Each patient must fulfill ALL of the following criteria and details:

1. Age ≥18 years
2. Heart failure resulting in NYHA class III or IV ambulatory
3. Ongoing management of heart failure according to ESC (European Society of Cardiology) (15) -guidelines during previous ≥6 months
4. Control with Arrhythmia with heart rate <110bpm
5. Life expectancy of at least 1 year
6. The patient should have the ability to fluently speak and understand the language in which the study is being conducted
7. Written, informed consent by the patient for participation in the study and agreement to comply with the follow-up schedule
8. Patient has had a successful Balloon Atrial Septostomy (BAS) procedure and is in a stable hemodynamic state, as assessed by the investigator
9. LVEF ≥15% and ≤ 70% , EF measured via Echocardiography 9.1.9.1. And for LVEF ≥ 40% (HFpEF): elevated NT-pro-BNP of ≥ 125 pg/ml
10. Elevated left ventricular filling pressure documented by 10.1. Either Pulmonary capillary wedge pressure (PCWP) or left ventricular end-diastolic pressure at rest ≥ 15 mmHg and greater then central venous preassure (CVP) 10.2. 10.2. Or: End-expiratory PCWP ≥25 mmHg at exercise and CVP <20 mm Hg
11. Transseptal catheterization and femoral vein access is determined to be feasible

Exclusion Criteria:

1. Local or generalized sepsis or other acute infection(s)
2. Any coagulation disorder, if clinically relevant in the opinion of the operator.
3. Allergy to nickel and/or titanium and/or nickel/titanium-based materials, if not medically manageable
4. Allergy to anti-platelet, -coagulant, or -thrombotic therapy, if not medically manageable
5. Intolerance to contrast agents, if not medically manageable
6. Participation in another medical trial testing a therapy less than 30 days before the intended AFR implantation procedure
7. Trans-oesophageal echocardiography and / or use of general anaesthetic is contraindicated
8. Breast feeding women

9. Pregnancy

   Processes which would technically disturb the safe intervention as planned:

10. Occluded inferior vena cava access
11. History of ASD and/or atrial septal repair or closure device in place

12. Intracardiac thrombus

    Clinical conditions:

13. Moderate valvular diseases requiring therapy according to current ESC guidelines. Patients are eligible in case therapy is formally indicated but cannot be performed due to technical or medial reasons if the latter is confirmed in writing by the PI in mutual agreement with the heart team and Severe aortic stenosis with valve area < 1.5cm² and Severe AR, TR or MR. Classification of severity of regurgitation should follow the definition provided in Lancelotti et al, Eur Heart J Cardiovasc Imaging 2013 [22]
14. Patients who has unstable and intractable angina pectoris

15. Evidence of right heart failure defined as (by ECHO)

    1. Severe Right Ventricular Dysfunction (TAPSE < 14 mm)
    2. Severe Right Ventricular Dilatation (RV volume ≥ LV volume)
    3. Severe pulmonary hypertension (PASP > 60 mm Hg)
16. Active malignancy
17. Severe valve disease, or implanted mechanical valve prosthesis
18. Congenital heart defect
19. Large PFO with significant atrial septal aneurysm (bubble test shows more than 20 bubbles)
20. Inability to perform 6-minutes walking test
21. Clinically relevant thrombocytopenia, thrombocytosis, leukopenia, or anemia
22. Symptomatic carotid artery disease
23. Mitral valve stenosis
24. Has any condition that, in the opinion of the Investigator, might interfere with the Implantation, might affect the patients well-being thereafter or might interfere with the conduct of the study
25. Systolic blood pressure of >170 mmHg, despite medical therapy
26. Severe lung disease (causing PHT with systolic PAP >60mmHg)
27. Pulmonary Hypertension (Systolic PAP >60mmHg)
28. TIA or stroke within the last 6 months
29. Scheduled for heart transplantation
30. Bleeding disorders (INR > 2.0, Thrombocytes < 100.000, Hemoglobin <8.0 gr/dl)
31. Myocardial infarction or percutaneous intervention or CABG (all within the last 3 month) or indication for a coronary intervention
32. Resyncronization therapy started within the last 6 months
33. Aneurysm of the septum
34. Hypertrophied Inter Atrial Septum (IAS) > 10mm depth
35. Hypertrophic Obstructive Cardiomyopathy (HOCM) or infiltrative CM as cause of HF
36. Thromboembolic events within the last 6 months
37. Dialysis and renal insufficiency requiring dialysis

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Belgium, Germany, Turkey

Administrative Information

• NCT Number: NCT03030274
• Other Study ID Numbers: Occ2016_06
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Occlutech International AB
• Original Responsible Party: Same as current
• Current Study Sponsor: Occlutech International AB
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Occlutech International AB
• Verification Date: September 2022