Post Market Registry of the CBSO

NCT04105595 | Unknown

• 1 other identifier: 2019.8408
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Atrial Septal Defect; Patent Foramen Ovale

Outcome Measures

Primary Outcomes (2)

• Effective closure by echocardiography

  at 6 months

• Safety throughout the follow up duration by absence of serious incidents

  day 0 to 3 years

Study Arms (2)

ASD patients

Device: Septal defect closure

PFO patients

Device: Septal defect closure

Interventions

Septal defect closure DEVICE

Device closure of atrial septal defect

ASD patients; PFO patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• atHeart Medical: lead

Study Sites (1)

Deutsches Herzzentrum Berlin

Berlin, Germany

Location

MeSH Terms

Conditions

Heart Septal Defects, Atrial; Foramen Ovale, Patent

Condition Hierarchy (Ancestors)

Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 3 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2019
• First Posted: September 26, 2019
• Study Start: March 5, 2020
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2024
• Last Updated: July 21, 2022

Record last verified: 2022-07

Locations

DE (1)