Occlutech Septal Occluder (Figulla Flex II) Study

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.

Study Overview

• Status: Completed
• Conditions: Secundum Atrial Septal Defects
• Intervention / Treatment: Device: 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 Type: Interventional
• Enrollment (Actual): 175
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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:

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Occlutech septal occluder ( Figulla Flex II); Occlutech septal occluder (Figulla Flex II)	Device: transcatheter closure of secundum atrial septal defects in patients; transcatheter closure of secundum atrial septal defects in patients
Active Comparator: Amplatzer Septal Occluder (ASO); St. Jude AGA septal occluder (Amplatzer ASO)	Device: transcatheter closure of secundum atrial septal defects in patients; transcatheter closure of secundum atrial septal defects in patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	at 6 months after the procedure.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety: Major, minor complications rate, all SAEs	Major and complications rate	6 and 12 months post procedure

Collaborators and Investigators

• Sponsor: Occlutech International AB

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2012
• Primary Completion (Actual): December 23, 2015
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: July 20, 2020
• First Submitted That Met QC Criteria: July 24, 2020
• First Posted (Actual): July 27, 2020

Study Record Updates

• Last Update Posted (Actual): July 27, 2020
• Last Update Submitted That Met QC Criteria: July 24, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Occlutech; Transcatheter closure of secundum atrial septal defects; Figulla Flex II; Occ201201
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Heart Defects, Congenital; Cardiovascular Abnormalities; Heart Septal Defects; Heart Septal Defects, Atrial; Foramen Ovale, Patent
• Other Study ID Numbers: Occ201201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No