Atrial Septal DefectCBSO RegistryNCT04105595
Post Market Registry of the CBSO
An observational study of Atrial Septal Defect and Patent Foramen Ovale, run by atHeart Medical at 1 site in Germany.
Trial summary
Multi centre, international, post market registry to monitor the clinical performance and safety of an atrial septal closure device with biodegradable framework in patients with clinically significant atrial septum defect (ASD) or patent foramen ovale (PFO) in routine clinical use Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atrial Septal Defect, Patent Foramen Ovale
- What is being tested?
- Septal defect closure
- Type of treatment
- Medical device
- How many people
- 6 participants
- Where
- 1 siteGermany
- Study dates
- 5 Mar 2020to Oct 2024
- How long will I take part?
- 3 Years
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Intent to treat population: All enrolled patients Modified Intent to Treat population: All enrolled patients who have a permanently implanted CBSO. Per Protocol population: All patients in the enrolled population who have a permanently implanted CBSO and do not have a major protocol deviation. The per protocol population will be used as the final population for analysis.
Who may be able to join
- Patient suffers from ASD (including ostium secundum ASD or a fenestration from a Fontan procedure) or PFO and is planned to receive the CBSO.
- Patient (or legal guardian) has been informed and agreed to and signed the informed consent form.
- A CBSO is implanted into the patient.
Who cannot join
- Patient is known to have one or more of the contraindications listed in the instructions for use.
- Patient is currently participating in one or more interventional studies, with exception of a study investigating the CBSO.
- Patient is implanted with another product in the atrial septum.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi Centre, International, Post Market Registry to Monitor the Clinical Performance and Safety of an Atrial Septal Closure Device With Bioresorbable Framework in Patients With Clinically Significant Atrial Septum Defect (ASD) or Patent Foramen Ovale (PFO) in Routine Clinical Use
Multi centre, international, post market registry to monitor the clinical performance and safety of an atrial septal closure device with biodegradable framework in patients with clinically significant atrial septum defect (ASD) or patent foramen ovale (PFO) in routine clinical use
- Conditions
- Atrial Septal Defect, Patent Foramen Ovale
- Being tested
- Septal defect closure
- 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.
Septal defect closureDevice
Device closure of atrial septal defect
| Study group | Role | What they receive |
|---|---|---|
| ASD patients | Not described Receives: Device: Septal defect closure | |
| PFO patients | Not described Receives: Device: Septal defect closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effective closure by echocardiography
Measured: at 6 months
Safety throughout the follow up duration by absence of serious incidents
Measured: day 0 to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start5 Mar 2020
- Primary completionOct 2023 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Septal DefectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 6 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- atHeart Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04105595
- Sponsor's protocol ID
- 2019.8408
- Acronym
- CBSO Registry
- Status last verified
- Jul 2022
- First submitted
- 24 Sep 2019
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi Centre, International, Post Market Registry to Monitor the Clinical Performance and Safety of an Atrial Septal Closure Device With Bioresorbable Framework in Patients With Clinically Significant Atrial Septum Defect (ASD) or Patent Foramen Ovale (PFO) in Routine Clinical Use
- ClinicalTrials.gov ID
- NCT04105595
- Acronym / sponsor ID
- CBSO Registry / 2019.8408
- Conditions
- Atrial Septal Defect, Patent Foramen Ovale
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (actual)
- Lead sponsor
- atHeart MedicalIndustry (pharma, biotech, devices)
- Study start
- 5 Mar 2020 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 26 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multi centre, international, post market registry to monitor the clinical performance and safety of an atrial septal closure device with biodegradable framework in patients with clinically significant atrial septum defect (ASD) or patent foramen ovale (PFO) in routine clinical use
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASD patients | – | Device: Septal defect closure |
| PFO patients | – | Device: Septal defect closure |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Intent to treat population: All enrolled patients Modified Intent to Treat population: All enrolled patients who have a permanently implanted CBSO. Per Protocol population: All patients in the enrolled population who have a permanently implanted CBSO and do not have a major protocol deviation. The per protocol population will be used as the final population for analysis.
Key inclusion criteria (3 listed)
- Patient suffers from ASD (including ostium secundum ASD or a fenestration from a Fontan procedure) or PFO and is planned to receive the CBSO.
- Patient (or legal guardian) has been informed and agreed to and signed the informed consent form.
- A CBSO is implanted into the patient.
Key exclusion criteria (3 listed)
- Patient is known to have one or more of the contraindications listed in the instructions for use.
- Patient is currently participating in one or more interventional studies, with exception of a study investigating the CBSO.
- Patient is implanted with another product in the atrial septum.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Septal defect closureDevice closure of atrial septal defect | Device | ASD patients, PFO patients |
Primary outcome
Effective closure by echocardiography
Time frame: at 6 months
Safety throughout the follow up duration by absence of serious incidents
Time frame: day 0 to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Septal Defect and Patent Foramen Ovale, run by atHeart Medical 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 21 Jul 2022. 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?
Results are not available in the source record.
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 by echocardiography (time frame: at 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jul 2022.