Occlutech Septal Occluder (Figulla Flex II) Study

NCT ID: NCT04488120

Last Updated: 2020-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 175 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-21
• Study Completion Date: 2017-10-31

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.

Conditions

Secundum Atrial Septal Defects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Occlutech septal occluder ( Figulla Flex II)

Occlutech septal occluder (Figulla Flex II)

Group Type: EXPERIMENTAL

transcatheter closure of secundum atrial septal defects in patients

Intervention Type: DEVICE

transcatheter closure of secundum atrial septal defects in patients

Amplatzer Septal Occluder (ASO)

St. Jude AGA septal occluder (Amplatzer ASO)

Group Type: ACTIVE_COMPARATOR

transcatheter closure of secundum atrial septal defects in patients

Intervention Type: DEVICE

transcatheter closure of secundum atrial septal defects in patients

Interventions

transcatheter closure of secundum atrial septal defects in patients

transcatheter closure of secundum atrial septal defects in patients

Intervention Type: DEVICE

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Occlutech International AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

Occ201201

Identifier Type: -

Identifier Source: org_study_id