Post Market Registry of the CBSO (CBSO Registry)

July 20, 2022 updated by: atHeart Medical

Multi Centre, International, Post Market Registry to Monitor the Clinical Performance and Safety of an Atrial Septal Closure Device With Bioresorbable Framework in Patients With Clinically Significant Atrial Septum Defect (ASD) or Patent Foramen Ovale (PFO) in Routine Clinical Use

Multi centre, international, post market registry to monitor the clinical performance and safety of an atrial septal closure device with biodegradable framework in patients with clinically significant atrial septum defect (ASD) or patent foramen ovale (PFO) in routine clinical use

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

6

Contacts and Locations

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

Study Locations

  • Germany
      • Berlin, Germany
        • Deutsches Herzzentrum Berlin

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

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Intent to treat population: All enrolled patients Modified Intent to Treat population: All enrolled patients who have a permanently implanted CBSO.

Per Protocol population: All patients in the enrolled population who have a permanently implanted CBSO and do not have a major protocol deviation. The per protocol population will be used as the final population for analysis.

Description

Inclusion Criteria:

  • Patient suffers from ASD (including ostium secundum ASD or a fenestration from a Fontan procedure) or PFO and is planned to receive the CBSO.
  • Patient (or legal guardian) has been informed and agreed to and signed the informed consent form.
  • A CBSO is implanted into the patient.

Exclusion Criteria:

  • Patient is known to have one or more of the contraindications listed in the instructions for use.
  • Patient is currently participating in one or more interventional studies, with exception of a study investigating the CBSO.
  • Patient is implanted with another product in the atrial septum.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ASD patients
Device: Septal defect closure
Device closure of atrial septal defect
PFO patients
Device: Septal defect closure
Device closure of atrial septal defect

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Effective closure by echocardiography
Time Frame: at 6 months
at 6 months
Safety throughout the follow up duration by absence of serious incidents
Time Frame: day 0 to 3 years
day 0 to 3 years

Collaborators and Investigators

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

Sponsor

atHeart Medical

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)

March 5, 2020

Primary Completion (Anticipated)

October 1, 2023

Study Completion (Anticipated)

October 1, 2024

Study Registration Dates

First Submitted

September 24, 2019

First Submitted That Met QC Criteria

September 25, 2019

First Posted (Actual)

September 26, 2019

Study Record Updates

Last Update Posted (Actual)

July 21, 2022

Last Update Submitted That Met QC Criteria

July 20, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019.8408

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.

Clinical Trials on Atrial Septal Defect

Clinical Trials on Septal defect closure

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Türkiye

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe