Secundum Atrial Septal DefectsNCT04488120
Occlutech Septal Occluder (Figulla Flex II) Study
A study testing transcatheter closure of secundum atrial septal defects in patients in people with Secundum Atrial Septal Defects, run by Occlutech International AB.
Trial summary
The objectives of the study are: To determine the efficacy of the Figulla Flex II device compared with that of the Amplatzer ASO device for transcatheter closure of secundum atrial septal defects To determine the safety of the Figulla Flex II device compared with that of the Amplatzer ASO device for transcatheter… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Secundum Atrial Septal Defects
- What is being tested?
- transcatheter closure of secundum atrial septal defects in patients
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- No sites listed yet
- Study dates
- 21 May 2012to Oct 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- A patient will be eligible for study participation if he/she meets the following criteria:
- Able to fluently speak and understand the language in which the study is being conducted
- Has ostium secundum atrial septal defect
- Has a defect hole with a diameter of < 38 mm
- Has a left-to-right shunt with a Qp/Qs ratio of ≥ 1.5:1 or the presence of right ventricular volume overload determined by transthoracic echo (TTE) or clinical symptoms due to the atrial septal defect
- Has a distance of > 5 mm from the margins of the defect(s) to the coronary sinus, arterioventricular (AV) valves and right upper pulmonary vein as measured by echocardiography
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- Agrees to participate in the study and comply with the follow-up schedule
- Is willing to freely give (or Legally Authorized Representative is willing to freely give) Informed Consent prior to treatment
- Willing to return for the post-treatment evaluation
Who cannot join
- Has multiple defects which can't adequately be covered by the device
- Has associated congenital cardiac anomalies which require cardiac surgery
- Has a known sensitivity to contrast media that cannot be controlled adequately with pre-medication.
- Patient is currently participating in another clinical device or drug trial that has not completed its primary endpoint or that will clinically confound the current study endpoints or does not permit subjects to participate in other studies. Typically, subjects that are involved in the long-term surveillance phase of a clinical study are eligible.
- Has ostium primum atrial septal defects
- Has sinus venosus atrial septal defects
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- Has partial anomolous pulmonary venous drainage
- Has pulmonary vascular resistance above 7 Woods units or a right-toleft shunt at the atrial level with a peripheral arterial saturation less than 94%
- Has a recent myocardial infarction, unstable angina and decompensated congestive heart failure (CHF)
- Has right and/or left ventricular decompensation with ejection fraction of < 30%
- Has an active bacterial and/or viral infection
- Has any type of serious infection < 1 month prior to the procedure
- Has malignancy where life expectancy is < 2 years
- Has demonstrated intracardiac thrombi on echocardiography
- Weighs < 8 kg
- Has gastritis, gastric ulcer, duodenal ulcer, etc. and other contraindications to aspirin therapy unless other anti-platelet agents can be administered for 6 months
- Has an unstable condition or otherwise thought to be unreliable or incapable of complying with the requirements of the clinical investigational plan (CIP).
- Has any disorder that, in the opinion of the Investigator, might interfere with the conduct of the study.
About this study
Official title: A Randomized, Controlled,Multi-Centre Trial of the Efficacy and Safety of the Occlutech Septal Occluder(Figulla Flex II) Compared to the AGA Septal Occluder(Amplatzer ASO) for Transcatheter Closure of Secundum ASD in Patients
The objectives of the study are:
- To determine the efficacy of the Figulla Flex II device compared with that of the Amplatzer ASO device for transcatheter closure of secundum atrial septal defects
- To determine the safety of the Figulla Flex II device compared with that of the Amplatzer ASO device for transcatheter closure of secundum atrial septal defects
This is a randomized, controlled, multi-centre trial of the efficacy and safety of the Occlutech septal occluder (Figulla Flex II) compared to the AGA septal occluder (Amplatzer ASO) for transcatheter closure of secundum atrial septal defects in patients.
Read the detailed description
Inclusion criteria A patient will be eligible for study participation if he/she meets the following criteria:
- Able to fluently speak and understand the language in which the study is being conducted
- Has ostium secundum atrial septal defect
- Has a defect hole with a diameter of < 38 mm
- Has a left-to-right shunt with a Qp/Qs ratio of . 1.5:1 or the presence of right ventricular volume overload determined by transthoracic echo (TTE) or clinical symptoms due to the atrial septal defect
- Has a distance of > 5 mm from the margins of the defect(s) to the coronary sinus, arterioventricular (AV) valves and right upper pulmonary vein as measured by echocardiography
- Agrees to participate in the study and comply with the follow-up schedule
- Is willing to freely give (or Legally Authorized Representative is willing to freely give) Informed Consent prior to treatment
- Willing to return for the post-treatment evaluation. Exclusion criteria
A patient will be excluded from the study if he/she meets the following criteria:
- Has multiple defects which can�ft adequately be covered by the device
- Has associated congenital cardiac anomalies which require cardiac surgery
- Has a known sensitivity to contrast media that cannot be controlled adequately with pre-medication.
- Patient is currently participating in another clinical device or drug trial that has not completed its primary endpoint or that will clinically confound the current study endpoints or does not permit subjects to participate in other studies. Typically, subjects that are involved in the long-term surveillance phase of a clinical study are eligible.
- Has ostium primum atrial septal defects
- Has sinus venosus atrial septal defects
- Has partial anomolous pulmonary venous drainage
- Has pulmonary vascular resistance above 7 Woods units or a right-toleft shunt at the atrial level with a peripheral arterial saturation less than 94%
- Has a recent myocardial infarction, unstable angina and decompensated congestive heart failure (CHF)
- Has right and/or left ventricular decompensation with ejection fraction of < 30%
- Has an active bacterial and/or viral infection
- Has any type of serious infection < 1 month prior to the procedure
- Has malignancy where life expectancy is < 2 years
- Has demonstrated intracardiac thrombi on echocardiography
- Weighs < 8 kg
- Has gastritis, gastric ulcer, duodenal ulcer, etc. and other contraindications to aspirin therapy unless other anti-platelet agents can be administered for 6 months
- Has an unstable condition or otherwise thought to be unreliable or incapable of complying with the requirements of the clinical investigational plan (CIP).
- Has any disorder that, in the opinion of the Investigator, might interfere with the conduct of the study.
- Conditions
- Secundum Atrial Septal Defects
- Being tested
- transcatheter closure of secundum atrial septal defects in patients
- Keywords
- Occlutech, Transcatheter closure of secundum atrial septal defects, Figulla Flex II, Occ201201
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcatheter closure of secundum atrial septal defects in patientsDevice
transcatheter closure of secundum atrial septal defects in patients
| Study group | Role | What they receive |
|---|---|---|
| Occlutech septal occluder ( Figulla Flex II) | Experimental | Occlutech septal occluder (Figulla Flex II) Receives: Device: transcatheter closure of secundum atrial septal defects in patients |
| Amplatzer Septal Occluder (ASO) | Active comparator | St. Jude AGA septal occluder (Amplatzer ASO) Receives: Device: transcatheter closure of secundum atrial septal defects in patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: the rate of a successful placement of the device
The primary efficacy endpoint was early efficacy success rate, which was defined as the rate of a successful placement of the device, and successful closure of the defects without major complication, surgical reintervention, device embolization or moderate or large residual shunt the day after procedure but no later than 36 hours after the procedure.
Measured: the day after procedure but no later than 36 hours after the procedure.
Efficacy:The secondary efficacy endpoint is the rate of closure success (residual shunt is smaller than or equal to 2 mm) within 6 months after the procedure, without the need for surgical repair.
The secondary efficacy endpoint is the rate of closure success (residual shunt is smaller than or equal to 2 mm) within 6 months after the procedure, without the need for surgical repair.
Measured: within 6 months after the procedure
Efficacy:Other efficacy endpoint was the rate of complete closure (no residual shunt) at 6 months after the procedure.
Other efficacy endpoint was the rate of complete closure (no residual shunt) at 6 months after the procedure.
Measured: at 6 months after the procedure.
Secondary outcomes (1)
Safety: Major, minor complications rate, all SAEs
Major and complications rate
Measured: 6 and 12 months post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2020
- Study start21 May 2012
- Primary completion23 Dec 2015
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Secundum Atrial Septal DefectsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, controlled, multi-centre trial of the efficacy and safety of the Occlutech septal occluder (Figulla Flex II) compared to the AGA septal occluder (Amplatzer ASO) for transcatheter closure of secundum atrial septal defects in patients.
- Masking
- None (open label)
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Occlutech International AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04488120
- Sponsor's protocol ID
- Occ201201
- Status last verified
- Jul 2020
- First submitted
- 20 Jul 2020
- Last updated
- 27 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled,Multi-Centre Trial of the Efficacy and Safety of the Occlutech Septal Occluder(Figulla Flex II) Compared to the AGA Septal Occluder(Amplatzer ASO) for Transcatheter Closure of Secundum ASD in Patients
- ClinicalTrials.gov ID
- NCT04488120
- Acronym / sponsor ID
- Occ201201
- Conditions
- Secundum Atrial Septal Defects
- Keywords
- Occlutech, Transcatheter closure of secundum atrial septal defects, Figulla Flex II, Occ201201
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Occlutech International ABIndustry (pharma, biotech, devices)
- Study start
- 21 May 2012 (actual)
- Primary completion
- 23 Dec 2015 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 27 Jul 2020 (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.
The objectives of the study are:
- To determine the efficacy of the Figulla Flex II device compared with that of the Amplatzer ASO device for transcatheter closure of secundum atrial septal defects
- To determine the safety of the Figulla Flex II device compared with that of the Amplatzer ASO device for transcatheter closure of secundum atrial septal defects
This is a randomized, controlled, multi-centre trial of the efficacy and safety of the Occlutech septal occluder (Figulla Flex II) compared to the AGA septal occluder (Amplatzer ASO) for transcatheter closure of secundum atrial septal defects in patients.
Detailed description
Inclusion criteria A patient will be eligible for study participation if he/she meets the following criteria:
- Able to fluently speak and understand the language in which the study is being conducted
- Has ostium secundum atrial septal defect
- Has a defect hole with a diameter of < 38 mm
- Has a left-to-right shunt with a Qp/Qs ratio of . 1.5:1 or the presence of right ventricular volume overload determined by transthoracic echo (TTE) or clinical symptoms due to the atrial septal defect
- Has a distance of > 5 mm from the margins of the defect(s) to the coronary sinus, arterioventricular (AV) valves and right upper pulmonary vein as measured by echocardiography
- Agrees to participate in the study and comply with the follow-up schedule
- Is willing to freely give (or Legally Authorized Representative is willing to freely give) Informed Consent prior to treatment
- Willing to return for the post-treatment evaluation. Exclusion criteria
A patient will be excluded from the study if he/she meets the following criteria:
- Has multiple defects which can�ft adequately be covered by the device
- Has associated congenital cardiac anomalies which require cardiac surgery
- Has a known sensitivity to contrast media that cannot be controlled adequately with pre-medication.
- Patient is currently participating in another clinical device or drug trial that has not completed its primary endpoint or that will clinically confound the current study endpoints or does not permit subjects to participate in other studies. Typically, subjects that are involved in the long-term surveillance phase of a clinical study are eligible.
- Has ostium primum atrial septal defects
- Has sinus venosus atrial septal defects
- Has partial anomolous pulmonary venous drainage
- Has pulmonary vascular resistance above 7 Woods units or a right-toleft shunt at the atrial level with a peripheral arterial saturation less than 94%
- Has a recent myocardial infarction, unstable angina and decompensated congestive heart failure (CHF)
- Has right and/or left ventricular decompensation with ejection fraction of < 30%
- Has an active bacterial and/or viral infection
- Has any type of serious infection < 1 month prior to the procedure
- Has malignancy where life expectancy is < 2 years
- Has demonstrated intracardiac thrombi on echocardiography
- Weighs < 8 kg
- Has gastritis, gastric ulcer, duodenal ulcer, etc. and other contraindications to aspirin therapy unless other anti-platelet agents can be administered for 6 months
- Has an unstable condition or otherwise thought to be unreliable or incapable of complying with the requirements of the clinical investigational plan (CIP).
- Has any disorder that, in the opinion of the Investigator, might interfere with the conduct of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a randomized, controlled, multi-centre trial of the efficacy and safety of the Occlutech septal occluder (Figulla Flex II) compared to the AGA septal occluder (Amplatzer ASO) for transcatheter closure of secundum atrial septal defects in patients.
| Arm | Type | Receives |
|---|---|---|
| Occlutech septal occluder ( Figulla Flex II) | Experimental | Device: transcatheter closure of secundum atrial septal defects in patientsOcclutech septal occluder (Figulla Flex II) |
| Amplatzer Septal Occluder (ASO) | Active comparator | Device: transcatheter closure of secundum atrial septal defects in patientsSt. Jude AGA septal occluder (Amplatzer ASO) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- A patient will be eligible for study participation if he/she meets the following criteria:
- Able to fluently speak and understand the language in which the study is being conducted
- Has ostium secundum atrial septal defect
- Has a defect hole with a diameter of < 38 mm
- Has a left-to-right shunt with a Qp/Qs ratio of ≥ 1.5:1 or the presence of right ventricular volume overload determined by transthoracic echo (TTE) or clinical symptoms due to the atrial septal defect
Key exclusion criteria (18 listed)
- Has multiple defects which can't adequately be covered by the device
- Has associated congenital cardiac anomalies which require cardiac surgery
- Patient is currently participating in another clinical device or drug trial that has not completed its primary endpoint or that will clinically confound the current study endpoints or does not permit subjects to participate in other studies. Typically, subjects that are involved in the long-term surveillance phase of a clinical study are eligible.
- Has ostium primum atrial septal defects
- Has sinus venosus atrial septal defects
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 |
|---|---|---|
| transcatheter closure of secundum atrial septal defects in patientstranscatheter closure of secundum atrial septal defects in patients | Device | Amplatzer Septal Occluder (ASO), Occlutech septal occluder ( Figulla Flex II) |
Primary outcome
Efficacy: the rate of a successful placement of the device
Time frame: the day after procedure but no later than 36 hours after the procedure.
The primary efficacy endpoint was early efficacy success rate, which was defined as the rate of a successful placement of the device, and successful closure of the defects without major complication, surgical reintervention, device embolization or moderate or large residual shunt the day after procedure but no later than 36 hours after the procedure.
Efficacy:The secondary efficacy endpoint is the rate of closure success (residual shunt is smaller than or equal to 2 mm) within 6 months after the procedure, without the need for surgical repair.
Time frame: within 6 months after the procedure
The secondary efficacy endpoint is the rate of closure success (residual shunt is smaller than or equal to 2 mm) within 6 months after the procedure, without the need for surgical repair.
Efficacy:Other efficacy endpoint was the rate of complete closure (no residual shunt) at 6 months after the procedure.
Time frame: at 6 months after the procedure.
Other efficacy endpoint was the rate of complete closure (no residual shunt) at 6 months after the procedure.
1 secondary outcome
Safety: Major, minor complications rate, all SAEs
Time frame: 6 and 12 months post procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Secundum Atrial Septal Defects
Not yet recruiting
Dapagliflozin and Right Heart Recovery After ASD Device Closure
ASD2(Secundum Atrial Septal Defect)
Active, not recruiting
Safety and Efficacy Study of reSept ASD Occluder for Treating Secundum ASD
Heart Septal Defect, Heart Septal Defects, Atrial
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.
Questions about this trial
What is this clinical trial studying?
A study testing transcatheter closure of secundum atrial septal defects in patients in people with Secundum Atrial Septal Defects, run by Occlutech International AB.
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 9 inclusion and 18 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 27 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Efficacy: the rate of a successful placement of the device (time frame: the day after procedure but no later than 36 hours after the procedure.). The study lists 3 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 27 Jul 2020.