FIH Study With CBSO

Prospective Single Center Pilot Clinical Study to Evaluate the Safety and Effectiveness of an Intracardiac Septal Closure Device With Biodegradable Framework in Patients With Clinically Significant Atrial Septum Defect (ASD) or Patent Foramen Ovale (PFO)

NCT01960491•Carag AG

View on ClinicalTrials.gov

Summary

The objective of this study is to evaluate the effectiveness and the safety of the intracardiac septal closure device (CBO), as well as the practicability of implantation of this device using the accessories (DS for CBO).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age greater than 18 years - no upper limit of age
•Body weight \> 40 kg
•Patients with an isolated ASD or PFO determined as suitable for closure via a commercially available device
•In ASD patients, echocardiographic evidence of right ventricular overload, and a stretched diameter of the defect up to 25 mm
•In patients with PFO, echocardiographic evidence of right to left shunt, and intraatrial tunnel length up to 4 mm
•Signed informed consent, respectively ability to give written informed consent after being told of the potential benefits and risks of entering the trial
•For female patients of child bearing capacity: Exclusion of pregnancy before start of the study and willingness to use adequate contraceptive methods to prevent pregnancy during the study

Exclusion Criteria

•ASD/PFO larger than a stretched diameter of 25 mm, or defects unsuitable for percutaneous closure
•Intraatrial tunnel longer than 4 mm
•Multiple or fenestrated ASD, ostium primum or sinus venosus atrial septal defect, coronary sinus defect
•Any significant cardiac valve dysfunction
•Anomalous pulmonary veins
•Defects with inadequate margins, as is consistent with current standards of care, such that the device will not position appropriately so as to avoid interference with other cardiac structure, or that will subject the device to increased risk of embolization post deployment.
•Acquired pathological or congenital deficiencies of the cardiovascular system (any other than ASD; e.g. transposition of vessels, calcification, myocardial infarction, intracardiac thrombi), being clinically significant, respectively interfering in the investigator's opinion with the conduct of study
•Clinically significant dilated cardiomyopathy (paroxysmal or caused by e.g. myocarditis or other reasons)
•Any patient known to have extensive or complex congenital cardiac anomaly which can only be adequately repaired by way of cardiac surgery
•Echocardiographic evidence of thrombus in the left atrium, left atrial appendage, or other cardiac chamber, and in the inferior vena cava.
+12 more criteria

Locations (1)

CardioVaskuläres Centrum

Frankfurt, Germany

Key Dates

Start Date

May 1, 2014

Primary Completion Date

January 1, 2017

Completion Date

June 1, 2018

Last Updated

October 11, 2018

Enrollment

ACTUAL participants

Conditions

Atrial Septal Defect (ASD)Patent Foramen Ovale (PFO)

Interventions

Device Closure of Atrial Septal Defect

DEVICE

Non-Invasive Detection of Right-to-Left Cardiac Shunts

NCT07420400

Patent Foramen Ovale (PFO)

View study

RECRUITING

Cerebral Microembolization Associated With PFO Closure

NCT06347276

Thrombosis CardiacAtrial Septal Defect+1 more

View study

COMPLETEDNA

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 11, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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FIH Study With CBSO

Inclusion Criteria

Exclusion Criteria

Non-Invasive Detection of Right-to-Left Cardiac Shunts

Cerebral Microembolization Associated With PFO Closure

Novel Modified Technique for Transcatheter Closure of Secundum Atrial Septal Defect: A Single Center Experience