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FIH Study With CBSO

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01960491
Recruitment Status : Completed
First Posted : October 10, 2013
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
Carag AG

Tracking Information
First Submitted Date  ICMJE October 8, 2013
First Posted Date  ICMJE October 10, 2013
Last Update Posted Date October 11, 2018
Study Start Date  ICMJE May 2014
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2013)
Effective closure of defect [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01960491 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE FIH Study With CBSO
Official Title  ICMJE 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)
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Atrial Septal Defect (ASD)
  • Patent Foramen Ovale (PFO)
Intervention  ICMJE Device: Device Closure of Atrial Septal Defect
Device Closure of Atrial Septal Defect by "Carag Bioresorbable Septal Occluder"
Study Arms  ICMJE Experimental: Device Closure of Atrial Septal Defect
Intervention: Device: Device Closure of Atrial Septal Defect
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 27, 2016)
15
Original Estimated Enrollment  ICMJE
 (submitted: October 9, 2013)
10
Actual Study Completion Date  ICMJE June 2018
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
  • 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
  • Known hypercoagulable state
  • Anamnesis respectively diagnosis of pregnancy, or breastfeeding patients
  • Any disorder in the investigator's opinion that could interfere with compliance or safety evaluation as well as any severe concurrent illness that would limit life expectancy (e.g. malignancies)
  • Participation in an investigational drug or device trial within 30 days prior to selection (day 0) or current inclusion in any other clinical trial or research project
  • Subjects who, in the opinion of the investigator, will be inappropriate for inclusion into this clinical trial or will not comply with requirements of the study
  • Patients who are kept lawfully in an institution
  • Clinical investigations shall be conducted in vulnerable populations only when they cannot be carried out in non-vulnerable populations and shall follow the additional ethics committee procedures where applicable. These clinical investigations shall be designed specifically to address health problems that occur in the vulnerable population, and offer the possibility of direct health-related benefit to the vulnerable population
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01960491
Other Study ID Numbers  ICMJE 2013.4678
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Carag AG
Study Sponsor  ICMJE Carag AG
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Horst Sievert, Prof. Dr. CardioVaskuläres Centrum Frankfurt, Germany
PRS Account Carag AG
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP