Atrial Flow Regulator in Heart Failure (PROLONGER)

April 2, 2020 updated by: Szpitale Pomorskie Sp. z o. o.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Poland
      • Wejherowo, Poland, 84-200
        • Recruiting
        • Kashubian Cardiovascular Center
        • Contact:
        • Contact:
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
OTHER: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Clinical improvement
Time Frame: 12 months
Increase in 6 minutes walk test distance
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinical improvement II
Time Frame: 12 months
Reduction in New York Heart Association (NYHA) class
12 months
Device related adverse event
Time Frame: 12 months
Device migration, embolization, device related thrombus, shunt occlusion, need for device removal
12 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pulmonary artery wedge pressure (PAWP) at rest
Time Frame: 30 days after AFR
Reduction of PAWP at rest
30 days after AFR
Pulmonary artery wedge pressure (PAWP) during handgrip test
Time Frame: 30 days after AFR
Reduction of PAWP during handgrip test
30 days after AFR
KCCQ-12
Time Frame: 12 months
Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
12 months
Clinical adverse event
Time Frame: 12 months
Cardiac mortality
12 months
Clinical adverse event II
Time Frame: 12 months
Rehospitalization for HF decompensation
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Szpitale Pomorskie Sp. z o. o.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lukasz Lewicki, MD,PhD, Kashubian Cardiovascular Center; University Center for Cardiology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 7, 2020

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2022

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 2, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 6, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 6, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 01/2020/W

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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