The Prelieve Trial - Pilot Study to Assess Safety and Efficacy of a Novel Atrial Flow Regulator (AFR) in Heart Failure Patients (PRELIEVE)
Primary Purpose
Heart Failure Low Output, Heart Failure
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Occlutech AFR device
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure Low Output
Eligibility Criteria
Inclusion criteria. Each patient must fulfill ALL of the following criteria and details:
- Age ≥18 years
- Heart failure resulting in NYHA class III or IV ambulatory
- Ongoing management of heart failure according to ESC (European Society of Cardiology) (15) -guidelines during previous ≥6 months
- Control with Arrhythmia with heart rate <110bpm
- Life expectancy of at least 1 year
- The patient should have the ability to fluently speak and understand the language in which the study is being conducted
- Written, informed consent by the patient for participation in the study and agreement to comply with the follow-up schedule
- Patient has had a successful Balloon Atrial Septostomy (BAS) procedure and is in a stable hemodynamic state, as assessed by the investigator
- 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
- 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
- Transseptal catheterization and femoral vein access is determined to be feasible
Exclusion Criteria:
- Local or generalized sepsis or other acute infection(s)
- Any coagulation disorder, if clinically relevant in the opinion of the operator.
- Allergy to nickel and/or titanium and/or nickel/titanium-based materials, if not medically manageable
- Allergy to anti-platelet, -coagulant, or -thrombotic therapy, if not medically manageable
- Intolerance to contrast agents, if not medically manageable
- Participation in another medical trial testing a therapy less than 30 days before the intended AFR implantation procedure
- Trans-oesophageal echocardiography and / or use of general anaesthetic is contraindicated
- Breast feeding women
Pregnancy
Processes which would technically disturb the safe intervention as planned:
- Occluded inferior vena cava access
- History of ASD and/or atrial septal repair or closure device in place
Intracardiac thrombus
Clinical conditions:
- 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]
- Patients who has unstable and intractable angina pectoris
Evidence of right heart failure defined as (by ECHO)
- Severe Right Ventricular Dysfunction (TAPSE < 14 mm)
- Severe Right Ventricular Dilatation (RV volume ≥ LV volume)
- Severe pulmonary hypertension (PASP > 60 mm Hg)
- Active malignancy
- Severe valve disease, or implanted mechanical valve prosthesis
- Congenital heart defect
- Large PFO with significant atrial septal aneurysm (bubble test shows more than 20 bubbles)
- Inability to perform 6-minutes walking test
- Clinically relevant thrombocytopenia, thrombocytosis, leukopenia, or anemia
- Symptomatic carotid artery disease
- Mitral valve stenosis
- 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
- Systolic blood pressure of >170 mmHg, despite medical therapy
- Severe lung disease (causing PHT with systolic PAP >60mmHg)
- Pulmonary Hypertension (Systolic PAP >60mmHg)
- TIA or stroke within the last 6 months
- Scheduled for heart transplantation
- Bleeding disorders (INR > 2.0, Thrombocytes < 100.000, Hemoglobin <8.0 gr/dl)
- Myocardial infarction or percutaneous intervention or CABG (all within the last 3 month) or indication for a coronary intervention
- Resyncronization therapy started within the last 6 months
- Aneurysm of the septum
- Hypertrophied Inter Atrial Septum (IAS) > 10mm depth
- Hypertrophic Obstructive Cardiomyopathy (HOCM) or infiltrative CM as cause of HF
- Thromboembolic events within the last 6 months
- Dialysis and renal insufficiency requiring dialysis
Sites / Locations
- AZ Maria Middelares
- UZ Leuven
- University Hospital Brussels
- Algemeen Stedelijk Ziekenhuis (Asz)
- OLV (Onze-Lieve-Vrouwziekenhuis) Hospital Aalst
- Charité - Universitätsmedizin Berlin
- Vivantes Klinikum im Friedrichshain
- Herzzentrum Uniklinik Köln
- CardioVasculäres Centrum Frankfurt
- Cardiologicum Hamburg
- Medizinische Hochschule Hannover
- University of Homburg
- Herzzentrum Leipzig
- Uniklinikum Magdeburg A. ö. R.
- Universitätsmedizin Rostock
- University of Würzburg
- Dışkapı Yıldırım Beyazıt Eğitim ve Araştırma Hastanesi
- Hacettepe Üni Hastanesi
- Ege Üniversitesi Hastanesi
- İstanbul Üniversitesi
- Kartal Koşuyolu Yüksek İhtisas Eğitim ve Araştırma Hastanesi
- Tepecik Eğitim Ve Araştırma Hastanesi
- Sivas Cumhuriyet Üniversitesi Tıp Fakültesi Araştırma ve Uygulama Hastanesi
- Bezmialem University
- Kocaeli Üniversitesi Hastanesi
- İzmir Kâtip Çelebi Üniversitesi
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Occlutech AFR Device
Arm Description
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
Outcomes
Primary Outcome Measures
Serious Adverse Device Effects (SADE) within 3 month following implantation.
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.
Secondary Outcome Measures
Serious Adverse Device Effects (SADE) between 3-12 month following implantation
Incidence of all Serious Adverse Device Effects (SADE) following implantation
Device placement
Device placement in situ
Left to Right shunt through the AFR device
Evidence of Left to Right shunt through the AFR device
Full Information
NCT ID
NCT03030274
First Posted
January 17, 2017
Last Updated
September 13, 2022
Sponsor
Occlutech International AB
1. Study Identification
Unique Protocol Identification Number
NCT03030274
Brief Title
The Prelieve Trial - Pilot Study to Assess Safety and Efficacy of a Novel Atrial Flow Regulator (AFR) in Heart Failure Patients
Acronym
PRELIEVE
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
October 11, 2017 (Actual)
Primary Completion Date
May 1, 2021 (Actual)
Study Completion Date
March 2, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Occlutech International AB
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure Low Output, Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
106 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Occlutech AFR Device
Arm Type
Experimental
Arm Description
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 Type
Device
Intervention Name(s)
Occlutech AFR device
Intervention Description
Catheter-guided placement of an AFR device following balloon atrial septostomy.
Primary Outcome Measure Information:
Title
Serious Adverse Device Effects (SADE) within 3 month following implantation.
Description
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.
Time Frame
0-3 month
Secondary Outcome Measure Information:
Title
Serious Adverse Device Effects (SADE) between 3-12 month following implantation
Description
Incidence of all Serious Adverse Device Effects (SADE) following implantation
Time Frame
3-12 month
Title
Device placement
Description
Device placement in situ
Time Frame
0-12 month
Title
Left to Right shunt through the AFR device
Description
Evidence of Left to Right shunt through the AFR device
Time Frame
0-12 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria. Each patient must fulfill ALL of the following criteria and details:
Age ≥18 years
Heart failure resulting in NYHA class III or IV ambulatory
Ongoing management of heart failure according to ESC (European Society of Cardiology) (15) -guidelines during previous ≥6 months
Control with Arrhythmia with heart rate <110bpm
Life expectancy of at least 1 year
The patient should have the ability to fluently speak and understand the language in which the study is being conducted
Written, informed consent by the patient for participation in the study and agreement to comply with the follow-up schedule
Patient has had a successful Balloon Atrial Septostomy (BAS) procedure and is in a stable hemodynamic state, as assessed by the investigator
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
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
Transseptal catheterization and femoral vein access is determined to be feasible
Exclusion Criteria:
Local or generalized sepsis or other acute infection(s)
Any coagulation disorder, if clinically relevant in the opinion of the operator.
Allergy to nickel and/or titanium and/or nickel/titanium-based materials, if not medically manageable
Allergy to anti-platelet, -coagulant, or -thrombotic therapy, if not medically manageable
Intolerance to contrast agents, if not medically manageable
Participation in another medical trial testing a therapy less than 30 days before the intended AFR implantation procedure
Trans-oesophageal echocardiography and / or use of general anaesthetic is contraindicated
Breast feeding women
Pregnancy
Processes which would technically disturb the safe intervention as planned:
Occluded inferior vena cava access
History of ASD and/or atrial septal repair or closure device in place
Intracardiac thrombus
Clinical conditions:
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]
Patients who has unstable and intractable angina pectoris
Evidence of right heart failure defined as (by ECHO)
Severe Right Ventricular Dysfunction (TAPSE < 14 mm)
Severe Right Ventricular Dilatation (RV volume ≥ LV volume)
Severe pulmonary hypertension (PASP > 60 mm Hg)
Active malignancy
Severe valve disease, or implanted mechanical valve prosthesis
Congenital heart defect
Large PFO with significant atrial septal aneurysm (bubble test shows more than 20 bubbles)
Inability to perform 6-minutes walking test
Clinically relevant thrombocytopenia, thrombocytosis, leukopenia, or anemia
Symptomatic carotid artery disease
Mitral valve stenosis
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
Systolic blood pressure of >170 mmHg, despite medical therapy
Severe lung disease (causing PHT with systolic PAP >60mmHg)
Pulmonary Hypertension (Systolic PAP >60mmHg)
TIA or stroke within the last 6 months
Scheduled for heart transplantation
Bleeding disorders (INR > 2.0, Thrombocytes < 100.000, Hemoglobin <8.0 gr/dl)
Myocardial infarction or percutaneous intervention or CABG (all within the last 3 month) or indication for a coronary intervention
Resyncronization therapy started within the last 6 months
Aneurysm of the septum
Hypertrophied Inter Atrial Septum (IAS) > 10mm depth
Hypertrophic Obstructive Cardiomyopathy (HOCM) or infiltrative CM as cause of HF
Thromboembolic events within the last 6 months
Dialysis and renal insufficiency requiring dialysis
Facility Information:
Facility Name
AZ Maria Middelares
City
Gent
State/Province
Buitenring Sint-Denijs 30
ZIP/Postal Code
9000
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
State/Province
Herestraat 49
ZIP/Postal Code
3000
Country
Belgium
Facility Name
University Hospital Brussels
City
Brussels
State/Province
Laarbeeklaan 101
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Algemeen Stedelijk Ziekenhuis (Asz)
City
Aalst
State/Province
Merestraat 80
ZIP/Postal Code
9300
Country
Belgium
Facility Name
OLV (Onze-Lieve-Vrouwziekenhuis) Hospital Aalst
City
Aalst
State/Province
Moorselbaan 164
ZIP/Postal Code
9300
Country
Belgium
Facility Name
Charité - Universitätsmedizin Berlin
City
Berlin
Country
Germany
Facility Name
Vivantes Klinikum im Friedrichshain
City
Berlin
Country
Germany
Facility Name
Herzzentrum Uniklinik Köln
City
Cologne
Country
Germany
Facility Name
CardioVasculäres Centrum Frankfurt
City
Frankfurt
Country
Germany
Facility Name
Cardiologicum Hamburg
City
Hamburg
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
Country
Germany
Facility Name
University of Homburg
City
Homburg
Country
Germany
Facility Name
Herzzentrum Leipzig
City
Leipzig
Country
Germany
Facility Name
Uniklinikum Magdeburg A. ö. R.
City
Magdeburg
Country
Germany
Facility Name
Universitätsmedizin Rostock
City
Rostock
Country
Germany
Facility Name
University of Würzburg
City
Würzburg
Country
Germany
Facility Name
Dışkapı Yıldırım Beyazıt Eğitim ve Araştırma Hastanesi
City
Ankara
State/Province
Altındağ
ZIP/Postal Code
06110
Country
Turkey
Facility Name
Hacettepe Üni Hastanesi
City
Ankara
State/Province
Altındağ
ZIP/Postal Code
06230
Country
Turkey
Facility Name
Ege Üniversitesi Hastanesi
City
İzmir
State/Province
Bornova
Country
Turkey
Facility Name
İstanbul Üniversitesi
City
Istanbul
State/Province
Fatih
ZIP/Postal Code
34452
Country
Turkey
Facility Name
Kartal Koşuyolu Yüksek İhtisas Eğitim ve Araştırma Hastanesi
City
Istanbul
State/Province
Kartal
ZIP/Postal Code
34865
Country
Turkey
Facility Name
Tepecik Eğitim Ve Araştırma Hastanesi
City
İzmir
State/Province
Konak
ZIP/Postal Code
35020
Country
Turkey
Facility Name
Sivas Cumhuriyet Üniversitesi Tıp Fakültesi Araştırma ve Uygulama Hastanesi
City
Sivas
State/Province
Merkez
ZIP/Postal Code
58140
Country
Turkey
Facility Name
Bezmialem University
City
Istanbul
Country
Turkey
Facility Name
Kocaeli Üniversitesi Hastanesi
City
Kocaeli
Country
Turkey
Facility Name
İzmir Kâtip Çelebi Üniversitesi
City
İzmir
State/Province
Çiğli
ZIP/Postal Code
35620
Country
Turkey
12. IPD Sharing Statement
Available IPD and Supporting Information:
Available IPD/Information Type
Publications
Available IPD/Information URL
http://pubmed.ncbi.nlm.nih.gov/31130524/
Available IPD/Information Identifier
NCT03030274
Available IPD/Information Comments
Christina Paitazoglou 1, Ramazan Özdemir, Roman Pfister, Martin W Bergmann, Jozef Bartunek, Teoman Kilic, Alexander Lauten, Alexander Schmeisser, Mehdi Zoghi, Stefan Anker, Horst Sievert, Felix Mahfoud_The AFR-PRELIEVE trial: a prospective, non-randomised, pilot study to assess the Atrial Flow Regulator (AFR) in heart failure patients with either preserved or reduced ejection fraction
Available IPD/Information Type
Publications
Available IPD/Information URL
http://pubmed.ncbi.nlm.nih.gov/33555114/
Available IPD/Information Identifier
NCT03030274
Available IPD/Information Comments
Christina Paitazoglou 1, Martin W Bergmann 1, Ramazan Özdemir 2, Roman Pfister 3, Jozef Bartunek 4, Teoman Kilic 5, Alexander Lauten 6, Alexander Schmeisser 7, Mehdi Zoghi 8, Stefan D Anker 6, Horst Sievert 9, Felix Mahfoud 10, AFR-PRELIEVE Investigators_One-year results of the first-in-man study investigating the Atrial Flow Regulator for left atrial shunting in symptomatic heart failure patients: the PRELIEVE study
Available IPD/Information Type
Publiactions
Available IPD/Information URL
http://pubmed.ncbi.nlm.nih.gov/34763641/
Available IPD/Information Identifier
NCT03030274
Available IPD/Information Comments
Nijad Bakhshaliyev 1, Ramazan Ozdemir 1_The impact of atrial flow regulator implantation on hemodynamic parameters in patients with heart failure
Learn more about this trial
The Prelieve Trial - Pilot Study to Assess Safety and Efficacy of a Novel Atrial Flow Regulator (AFR) in Heart Failure Patients
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