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Atrial Flow Regulator in Heart Failure (PROLONGER)

Primary Purpose

Congestive Heart Failure

Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Atrial flow regulator (Occlutech® AFR device)
Sponsored by
Szpitale Pomorskie Sp. z o. o.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congestive Heart Failure focused on measuring atrial flow regulator; heart failure; interatrial shunting

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kashubian Cardiovascular CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Atrial flow regulator

Arm Description

In this arm, patients who have elevated left ventricle filling pressures get (Occlutech® AFR device) and optimal therapy for Heart failure (HF).

Outcomes

Primary Outcome Measures

Clinical improvement
Increase in 6 minutes walk test distance

Secondary Outcome Measures

Clinical improvement II
Reduction in New York Heart Association (NYHA) class
Device related adverse event
Device migration, embolization, device related thrombus, shunt occlusion, need for device removal

Full Information

First Posted
April 2, 2020
Last Updated
April 2, 2020
Sponsor
Szpitale Pomorskie Sp. z o. o.
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1. Study Identification

Unique Protocol Identification Number
NCT04334694
Brief Title
Atrial Flow Regulator in Heart Failure
Acronym
PROLONGER
Official Title
Pomeranian atRial flOw reguLatOr iN conGestive hEart failuRe (PROLONGER) Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 7, 2020 (Actual)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
January 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Szpitale Pomorskie Sp. z o. o.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure
Keywords
atrial flow regulator; heart failure; interatrial shunting

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Atrial flow regulator
Arm Type
Other
Arm Description
In this arm, patients who have elevated left ventricle filling pressures get (Occlutech® AFR device) and optimal therapy for Heart failure (HF).
Intervention Type
Device
Intervention Name(s)
Atrial flow regulator (Occlutech® AFR device)
Intervention Description
Atrial septostomy followed by implantation of AFR.
Primary Outcome Measure Information:
Title
Clinical improvement
Description
Increase in 6 minutes walk test distance
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Clinical improvement II
Description
Reduction in New York Heart Association (NYHA) class
Time Frame
12 months
Title
Device related adverse event
Description
Device migration, embolization, device related thrombus, shunt occlusion, need for device removal
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Pulmonary artery wedge pressure (PAWP) at rest
Description
Reduction of PAWP at rest
Time Frame
30 days after AFR
Title
Pulmonary artery wedge pressure (PAWP) during handgrip test
Description
Reduction of PAWP during handgrip test
Time Frame
30 days after AFR
Title
KCCQ-12
Description
Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
Time Frame
12 months
Title
Clinical adverse event
Description
Cardiac mortality
Time Frame
12 months
Title
Clinical adverse event II
Description
Rehospitalization for HF decompensation
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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: Pulmonary artery wedge pressure (PAWP) at rest > 15 mmHg or 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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lukasz Lewicki, MD, PhD
Phone
+48501702885
Email
luklewicki@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Maciej Karwowski, MD
Phone
+48500473983
Email
maciejkarwowskimd@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lukasz Lewicki, MD,PhD
Organizational Affiliation
Kashubian Cardiovascular Center; University Center for Cardiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kashubian Cardiovascular Center
City
Wejherowo
ZIP/Postal Code
84-200
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lukasz Lewicki, MD,PhD
Phone
+48501702885
Email
luklewicki@gmail.com
First Name & Middle Initial & Last Name & Degree
Maciej Karwowski, MD
Phone
+48500473983
Email
maciejkarwowskimd@gmail.com
First Name & Middle Initial & Last Name & Degree
Lukasz Lewicki, MD,PhD
First Name & Middle Initial & Last Name & Degree
Maciej Karwowski, MD
First Name & Middle Initial & Last Name & Degree
Sebastian Liedtke, MD
First Name & Middle Initial & Last Name & Degree
Katarzyna Kosmalska, MD,PhD
First Name & Middle Initial & Last Name & Degree
Marek Szolkiewicz, MD,PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The following data will be available: echocardiography reports right heart catheterization reports clinical and demographic data
IPD Sharing Time Frame
The data will be available after completion of the study.
IPD Sharing Access Criteria
The data will be shared on personal request for review process.

Learn more about this trial

Atrial Flow Regulator in Heart Failure

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