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Atrial Flow Regulator in Heart Failure (PROLONGER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04334694
Recruitment Status : Unknown
Verified April 2020 by Szpitale Pomorskie Sp. z o. o..
Recruitment status was:  Recruiting
First Posted : April 6, 2020
Last Update Posted : April 6, 2020
Sponsor:
Information provided by (Responsible Party):
Szpitale Pomorskie Sp. z o. o.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Congestive Heart Failure Device: Atrial flow regulator (Occlutech® AFR device) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Pomeranian atRial flOw reguLatOr iN conGestive hEart failuRe (PROLONGER) Trial
Actual Study Start Date : January 7, 2020
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arms and Interventions
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Arm Intervention/treatment
Atrial flow regulator
In this arm, patients who have elevated left ventricle filling pressures get (Occlutech® AFR device) and optimal therapy for Heart failure (HF).
 Device: Atrial flow regulator (Occlutech® AFR device)
Atrial septostomy followed by implantation of AFR.


Outcome Measures
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Primary Outcome Measures :
  1. Clinical improvement [ Time Frame: 12 months ]
    Increase in 6 minutes walk test distance


Secondary Outcome Measures :
  1. Clinical improvement II [ Time Frame: 12 months ]
    Reduction in New York Heart Association (NYHA) class

  2. Device related adverse event [ Time Frame: 12 months ]
    Device migration, embolization, device related thrombus, shunt occlusion, need for device removal


Other Outcome Measures:
  1. Pulmonary artery wedge pressure (PAWP) at rest [ Time Frame: 30 days after AFR ]
    Reduction of PAWP at rest

  2. Pulmonary artery wedge pressure (PAWP) during handgrip test [ Time Frame: 30 days after AFR ]
    Reduction of PAWP during handgrip test

  3. KCCQ-12 [ Time Frame: 12 months ]
    Kansas City Cardiomyopathy Questionnaire (KCCQ-12)

  4. Clinical adverse event [ Time Frame: 12 months ]
    Cardiac mortality

  5. Clinical adverse event II [ Time Frame: 12 months ]
    Rehospitalization for HF decompensation


Eligibility Criteria
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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04334694


Contacts
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Contact: Lukasz Lewicki, MD, PhD +48501702885 luklewicki@gmail.com
Contact: Maciej Karwowski, MD +48500473983 maciejkarwowskimd@gmail.com

Locations
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Poland
Kashubian Cardiovascular Center Recruiting
Wejherowo, Poland, 84-200
Contact: Lukasz Lewicki, MD,PhD    +48501702885    luklewicki@gmail.com   
Contact: Maciej Karwowski, MD    +48500473983    maciejkarwowskimd@gmail.com   
Principal Investigator: Lukasz Lewicki, MD,PhD         
Sub-Investigator: Maciej Karwowski, MD         
Sub-Investigator: Sebastian Liedtke, MD         
Sub-Investigator: Katarzyna Kosmalska, MD,PhD         
Sub-Investigator: Marek Szolkiewicz, MD,PhD         
Sponsors and Collaborators
Szpitale Pomorskie Sp. z o. o.
Investigators
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Principal Investigator: Lukasz Lewicki, MD,PhD Kashubian Cardiovascular Center; University Center for Cardiology
More Information
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Responsible Party: Szpitale Pomorskie Sp. z o. o.
ClinicalTrials.gov Identifier: NCT04334694    
Other Study ID Numbers: 01/2020/W
First Posted: April 6, 2020    Key Record Dates
Last Update Posted: April 6, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

The following data will be available:

  • echocardiography reports
  • right heart catheterization reports
  • clinical and demographic data
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: The data will be available after completion of the study.
Access Criteria: The data will be shared on personal request for review process.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Szpitale Pomorskie Sp. z o. o.:
atrial flow regulator; heart failure; interatrial shunting
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases