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)

Carag AG1 site in 1 country15 target enrollmentMay 2014

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

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Atrial Septal Defect (ASD)
Sponsor: Carag AG
Enrollment: 15
Locations: 1
Primary Endpoint: Effective closure of defect
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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).

Registry

clinicaltrials.gov

Start Date

May 2014

End Date

June 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Carag AG

Responsible Party

Sponsor

Eligibility Criteria

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.