NCT04334694

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 7, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 6, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

April 6, 2020

Status Verified

April 1, 2020

Enrollment Period

2 years

First QC Date

April 2, 2020

Last Update Submit

April 2, 2020

Conditions

Congestive Heart Failure

Keywords

atrial flow regulator; heart failure; interatrial shunting

Outcome Measures

Primary Outcomes (1)

  • Clinical improvement

    Increase in 6 minutes walk test distance

    12 months

Secondary Outcomes (2)

  • Clinical improvement II

    12 months

  • Device related adverse event

    12 months

Other Outcomes (5)

  • Pulmonary artery wedge pressure (PAWP) at rest

    30 days after AFR

  • Pulmonary artery wedge pressure (PAWP) during handgrip test

    30 days after AFR

  • KCCQ-12

    12 months

  • +2 more other outcomes

Study Arms (1)

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).

Device: Atrial flow regulator (Occlutech® AFR device)

Interventions

Atrial flow regulator (Occlutech® AFR device)DEVICE

Atrial septostomy followed by implantation of AFR.

Atrial flow regulator

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kashubian Cardiovascular Center

Wejherowo, 84-200, Poland

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Lukasz Lewicki, MD,PhD

    Kashubian Cardiovascular Center; University Center for Cardiology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lukasz Lewicki, MD, PhD

CONTACT

+48501702885luklewicki@gmail.com

Maciej Karwowski, MD

CONTACT

+48500473983maciejkarwowskimd@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: All eligible patients will undergo detailed screening using echocardiography, impedance cardiography and right heart catheterization prior to AFR implantation.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2020

First Posted

April 6, 2020

Study Start

January 7, 2020

Primary Completion

January 1, 2022

Study Completion

January 1, 2022

Last Updated

April 6, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will share

The following data will be available: * echocardiography reports * right heart catheterization reports * clinical and demographic data

Shared Documents
STUDY PROTOCOL, SAP, 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.

Locations

PL(1)