Occlutech Septal Occluder (Figulla Flex II) Study

NCT04488120 | Completed DMC

• 1 other identifier: Occ201201
• Study Type: interventional
• Target: 175
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Secundum Atrial Septal Defects

Keywords

Occlutech; Transcatheter closure of secundum atrial septal defects; Figulla Flex II; Occ201201

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Safety: Major, minor complications rate, all SAEs

  6 and 12 months post procedure

Study Arms (2)

Occlutech septal occluder ( Figulla Flex II)

EXPERIMENTAL

Occlutech septal occluder (Figulla Flex II)

Device: transcatheter closure of secundum atrial septal defects in patients

Amplatzer Septal Occluder (ASO)

ACTIVE COMPARATOR

St. Jude AGA septal occluder (Amplatzer ASO)

Device: transcatheter closure of secundum atrial septal defects in patients

Interventions

transcatheter closure of secundum atrial septal defects in patients DEVICE

transcatheter closure of secundum atrial septal defects in patients

Amplatzer Septal Occluder (ASO); Occlutech septal occluder ( Figulla Flex II)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Occlutech International AB: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: July 20, 2020
• First Posted: July 27, 2020
• Study Start: May 21, 2012
• Primary Completion: December 23, 2015
• Study Completion: October 1, 2017
• Last Updated: July 27, 2020

Record last verified: 2020-07