FIH Study With CBSO

NCT01960491 | Completed

• 1 other identifier: 2013.4678
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Effective closure of defect

  6 months

Study Arms (1)

Device Closure of Atrial Septal Defect

EXPERIMENTAL

Device: Device Closure of Atrial Septal Defect

Interventions

Device Closure of Atrial Septal Defect DEVICE

Device Closure of Atrial Septal Defect by "Carag Bioresorbable Septal Occluder"

Device Closure of Atrial Septal Defect

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• Patients who within one month prior to implantation are known to have sepsis or any systemic infection that has not been successfully treated prior to device placement
• Active endocarditis or other infections producing bacteremia.
• Clinically relevant arrhythmia
• Patients whose vasculature, through which access to the defect is gained, is inadequate to accommodate the size of the device, the position controls or the introduction sheath
• Documented history of bleeding, clotting or coagulation disorders, untreated ulcer or any other contraindications to acetylsalicylic acid therapy, unless another anti-platelet agent can be administered for 6 months

Sponsors & Collaborators

• Carag AG: lead

Study Sites (1)

CardioVaskuläres Centrum

Frankfurt, 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 Officials

• Horst Sievert, Prof. Dr.

  CardioVaskuläres Centrum Frankfurt, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2013
• First Posted: October 10, 2013
• Study Start: May 1, 2014
• Primary Completion: January 1, 2017
• Study Completion: June 1, 2018
• Last Updated: October 11, 2018

Record last verified: 2018-10

Locations

DE (1)