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Atrial Flow Regulator in Heart Failure

NCT04334694 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-04-06

No results posted yet for this study

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.

Conditions

  • Congestive Heart Failure

Interventions

DEVICE

Atrial flow regulator (Occlutech® AFR device)

Atrial septostomy followed by implantation of AFR.

Sponsors & Collaborators

  • Szpitale Pomorskie Sp. z o. o.

    lead OTHER

Principal Investigators

  • Lukasz Lewicki, MD,PhD · Kashubian Cardiovascular Center; University Center for Cardiology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-07
Primary Completion
2022-01-31
Completion
2022-01-31

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04334694 on ClinicalTrials.gov