Occlutech Septal Occluder (Figulla Flex II) Study

Not Applicable

Completed

• Conditions: Secundum Atrial Septal Defects
• Interventions: Device: transcatheter closure of secundum atrial septal defects in patients

• Registration Number: NCT04488120
• Lead Sponsor: Occlutech International AB

Brief 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 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:

1. Able to fluently speak and understand the language in which the study is being conducted

2. Has ostium secundum atrial septal defect

3. Has a defect hole with a diameter of \< 38 mm

4. 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

5. 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

6. Agrees to participate in the study and comply with the follow-up schedule

7. Is willing to freely give (or Legally Authorized Representative is willing to freely give) Informed Consent prior to treatment

8. 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:

1. Has multiple defects which can�ft adequately be covered by the device

2. Has associated congenital cardiac anomalies which require cardiac surgery

a. Has a known sensitivity to contrast media that cannot be controlled adequately with pre-medication.

3. 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.

4. Has ostium primum atrial septal defects

5. Has sinus venosus atrial septal defects

6. Has partial anomolous pulmonary venous drainage

7. 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%

8. Has a recent myocardial infarction, unstable angina and decompensated congestive heart failure (CHF)

9. Has right and/or left ventricular decompensation with ejection fraction of \< 30%

10. Has an active bacterial and/or viral infection

11. Has any type of serious infection \< 1 month prior to the procedure

12. Has malignancy where life expectancy is \< 2 years

13. Has demonstrated intracardiac thrombi on echocardiography

14. Weighs \< 8 kg

15. Has gastritis, gastric ulcer, duodenal ulcer, etc. and other contraindications to aspirin therapy unless other anti-platelet agents can be administered for 6 months

16. Has an unstable condition or otherwise thought to be unreliable or incapable of complying with the requirements of the clinical investigational plan (CIP).

17. Has any disorder that, in the opinion of the Investigator, might interfere with the conduct of the study.

Study Timeline

• Study Start: 2012-05-21
• Primary Completion: 2015-12-23
• Study Completion: 2017-10
• Status Verified: 2020-07
• Study First Submitted: 2020-07-20
• Study First Submitted QC: 2020-07-24
• Last Update Submitted: 2020-07-24
• Study First Posted: 2020-07-27
• Last Update Posted: 2020-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 175

Inclusion Criteria

A patient will be eligible for study participation if he/she meets the following criteria:

1. Able to fluently speak and understand the language in which the study is being conducted
2. Has ostium secundum atrial septal defect
3. Has a defect hole with a diameter of < 38 mm
4. 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
5. 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
6. Agrees to participate in the study and comply with the follow-up schedule
7. Is willing to freely give (or Legally Authorized Representative is willing to freely give) Informed Consent prior to treatment
8. Willing to return for the post-treatment evaluation

Exclusion Criteria

1. Has multiple defects which can't adequately be covered by the device

2. Has associated congenital cardiac anomalies which require cardiac surgery

   a. Has a known sensitivity to contrast media that cannot be controlled adequately with pre-medication.

3. 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.

4. Has ostium primum atrial septal defects

5. Has sinus venosus atrial septal defects

6. Has partial anomolous pulmonary venous drainage

7. 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%

8. Has a recent myocardial infarction, unstable angina and decompensated congestive heart failure (CHF)

9. Has right and/or left ventricular decompensation with ejection fraction of < 30%

10. Has an active bacterial and/or viral infection

11. Has any type of serious infection < 1 month prior to the procedure

12. Has malignancy where life expectancy is < 2 years

13. Has demonstrated intracardiac thrombi on echocardiography

14. Weighs < 8 kg

15. Has gastritis, gastric ulcer, duodenal ulcer, etc. and other contraindications to aspirin therapy unless other anti-platelet agents can be administered for 6 months

16. Has an unstable condition or otherwise thought to be unreliable or incapable of complying with the requirements of the clinical investigational plan (CIP).

17. Has any disorder that, in the opinion of the Investigator, might interfere with the conduct of the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Amplatzer Septal Occluder (ASO)	transcatheter closure of secundum atrial septal defects in patients	St. Jude AGA septal occluder (Amplatzer ASO)
Occlutech septal occluder ( Figulla Flex II)	transcatheter closure of secundum atrial septal defects in patients	Occlutech septal occluder (Figulla Flex II)

Primary Outcome Measures

Name	Time	Method
Efficacy: the rate of a successful placement of the device	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.	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.	at 6 months after the procedure.	Other efficacy endpoint was the rate of complete closure (no residual shunt) at 6 months after the procedure.

Secondary Outcome Measures

Name	Time	Method
Safety: Major, minor complications rate, all SAEs	6 and 12 months post procedure	Major and complications rate