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Atrial Septal Defect (ASD)NCT01960491

FIH Study With CBSO

A study testing Device Closure of Atrial Septal Defect in people with Atrial Septal Defect (ASD) and Patent Foramen Ovale (PFO), run by Carag AG at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Device Closure of Atrial Septal Defect
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteGermany
Study dates
May 2014to Jun 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • CardioVaskuläres Centrum

    Frankfurt

Other trials in Germany

About this study

Official title: 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)

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).

Being tested
Device Closure of Atrial Septal Defect
Medical subject headings
Heart Septal Defects, Atrial, Foramen Ovale, Patent

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Device Closure of Atrial Septal DefectDevice

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

Study groups in NCT01960491
Study groupRoleWhat they receive
Device Closure of Atrial Septal DefectExperimentalNot described
Receives: Device: Device Closure of Atrial Septal Defect

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Effective closure of defect

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2013 (estimated)
  2. Study startMay 2014
  3. Primary completionJan 2017
  4. Study completionJun 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01960491
Sponsor's protocol ID
2013.4678
Status last verified
Oct 2018
First submitted
8 Oct 2013
Last updated
11 Oct 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Device Closure of Atrial Septal Defect in people with Atrial Septal Defect (ASD) and Patent Foramen Ovale (PFO), run by Carag AG at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effective closure of defect (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01960491.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2018.

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