Congestive Heart FailurePROLONGERNCT04334694
Atrial Flow Regulator in Heart Failure
A study testing Atrial flow regulator (Occlutech® AFR device) in people with Congestive Heart Failure, run by Szpitale Pomorskie Sp. z o. o. at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- Atrial flow regulator (Occlutech® AFR device)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePoland
- Study dates
- 7 Jan 2020to Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Written informed consent obtained from the patient
- Left ventricle ejection fraction (LVEF) ≥ 15%
- Elevated left heart filling pressures:
- Pulmonary artery wedge pressure (PAWP) at rest > 15 mmHg or
- PAWP > 25 mmHg during hand grip test
Who cannot join
- 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
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- 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:
- Right atrial pressure ≥ PAWP (measured in right heart catheterization)
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Kashubian Cardiovascular Center
Wejherowo, 84-200
Lukasz Lewicki, MD,PhD, +48501702885, luklewicki@gmail.com
Maciej Karwowski, MD, +48500473983, maciejkarwowskimd@gmail.com
About this study
Official title: Pomeranian atRial flOw reguLatOr iN conGestive hEart failuRe (PROLONGER) Trial
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.
- Conditions
- Congestive Heart Failure
- Being tested
- Atrial flow regulator (Occlutech® AFR device)
- Keywords
- atrial flow regulator; heart failure; interatrial shunting
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atrial flow regulator (Occlutech® AFR device)Device
Atrial septostomy followed by implantation of AFR.
| Study group | Role | What they receive |
|---|---|---|
| Atrial flow regulator | Other | In this arm, patients who have elevated left ventricle filling pressures get (Occlutech® AFR device) and optimal therapy for Heart failure (HF). Receives: Device: Atrial flow regulator (Occlutech® AFR device) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical improvement
Increase in 6 minutes walk test distance
Measured: 12 months
Secondary outcomes (2)
Clinical improvement II
Reduction in New York Heart Association (NYHA) class
Measured: 12 months
Device related adverse event
Device migration, embolization, device related thrombus, shunt occlusion, need for device removal
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2020
- Study start7 Jan 2020
- Primary completionJan 2022 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All eligible patients will undergo detailed screening using echocardiography, impedance cardiography and right heart catheterization prior to AFR implantation.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Szpitale Pomorskie Sp. z o. o.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lukasz Lewicki, MD,PhD, Principal investigator, Kashubian Cardiovascular Center; University Center for Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04334694
- Sponsor's protocol ID
- 01/2020/W
- Acronym
- PROLONGER
- Status last verified
- Apr 2020
- First submitted
- 2 Apr 2020
- Last updated
- 6 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The following data will be available: * echocardiography reports * right heart catheterization reports * clinical and demographic data
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pomeranian atRial flOw reguLatOr iN conGestive hEart failuRe (PROLONGER) Trial
- ClinicalTrials.gov ID
- NCT04334694
- Acronym / sponsor ID
- PROLONGER / 01/2020/W
- Conditions
- Congestive Heart Failure
- Keywords
- atrial flow regulator; heart failure; interatrial shunting
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Szpitale Pomorskie Sp. z o. o.University, hospital or other
- Study start
- 7 Jan 2020 (actual)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 6 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All eligible patients will undergo detailed screening using echocardiography, impedance cardiography and right heart catheterization prior to AFR implantation.
| Arm | Type | Receives |
|---|---|---|
| Atrial flow regulator | Other | Device: Atrial flow regulator (Occlutech® AFR device)In this arm, patients who have elevated left ventricle filling pressures get (Occlutech® AFR device) and optimal therapy for Heart failure (HF). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atrial flow regulator (Occlutech® AFR device)Atrial septostomy followed by implantation of AFR. | Device | Atrial flow regulator |
Primary outcome
Clinical improvement
Time frame: 12 months
Increase in 6 minutes walk test distance
2 secondary outcomes
Clinical improvement II
Time frame: 12 months
Device related adverse event
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2020.
- Individual participant dataSharing planned: Yes. The following data will be available: * echocardiography reports * right heart catheterization reports * clinical and demographic data
Related trials for Congestive Heart Failure
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
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Vsling™ III: Clinical Evaluation of the Vsling™ Device for Ventricular Repair in Patients With Heart Failure
HFrEF - Heart Failure With Reduced Ejection Fraction
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A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Heart Failure
Heart Failure
Active, not recruiting
Fast Induced Remodeling in Heart Failure With Preserved Ejection Fraction
Heart Failure With Preserved Ejection Fraction, Concentric Hypertrophy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lukasz Lewicki, MD,PhD principal investigator
Kashubian Cardiovascular Center; University Center for Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atrial flow regulator (Occlutech® AFR device) in people with Congestive Heart Failure, run by Szpitale Pomorskie Sp. z o. o. at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lukasz Lewicki, MD, PhD (+48501702885, luklewicki@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical improvement (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2020.