Hyperion™ International Registry Trial

Study Overview
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Brief Summary
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The purpose of this study is to determine the safety, performance and efficacy of the Hyperion™ Occluder Systems during treatment of ASD and PDA patients.

Official Title
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A Prospective, Multi-center Study to Evaluate the Safety and Performance of the Hyperion™ ASD and PDA Closure Systems.

Conditions
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Atrial Septal Defects, Patent Ductus Arteriosus

Intervention / Treatment
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* Device: ASD and PDA closure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has ASD or PDA documented by a Transoesophagial echocardiography (TEE) or a Transthoracic echocardiography (TTE) and indication for closure that is amenable to treatment with the Hyperion™ ASD or PDA occluder For PDA: Patient age ≥ 1 year old For ASD: Patient weighting ≥15 kg of any age Patient is willing and able to comply with specified follow-up evaluations Patient or legally authorized representative has been informed of the nature of the study, agrees to its provisions and has been provided written Notice of Informed Consent, approved by the appropriate Ethics Committee (EC) Exclusion Criteria: Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test Patient has other medical illness (e.g., cancer, known malignancy, congestive heart failure, organ transplant recipient or candidate) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy (i.e., less than 1 year) Patient has a known hypersensitivity or contraindication to aspirin, heparin, and/or contrast sensitivity that cannot be adequately pre-medicated Currently participating in another clinical study Active endocarditis, active bacterial infection, or other infection producing bacteremia or sepsis Congenital or structural heart disease other than ASD or PDA Thrombus at the intended site of implant or documented venous thrombosis in venous access Severe pulmonary hypertension Vascular anatomy unable to accommodate the appropriate-sized sheath for device introduction ASD or PDA anatomy non suitable for the Hyperion™ closure device Confinement to bed (increased risk for clot formation) Prior cardiac implantation of cardiac devices for ASD or PDA closure

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patient with PDA or ASD<br> | Device: ASD and PDA closure<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success of implantation | Success of implantation without death, stroke, any device embolization, puncture site bleeding requiring surgical repair or blood transfusion and without any other device or procedure related MAE at 30 days | 30 days | 
| Device success | Device success defined as ASD or PDA closure at 6 months post procedure by a Transthoracic echocardiography (TTE) or a Transesophageal echocardiography (TEE). | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Events | Major Adverse Events at 6 and 12 months defined as composite rate of all death, stroke, any device embolization, puncture site bleeding requiring surgical repair or blood transfusion at discharge and any other device or procedure related MAE. Components of Major Adverse Events at discharge, 30 days, 6, and 12 months. | 30 days, 6 and 12 months | 
| Procedure success | Procedure success defined as successful deployment of the Hyperion™ Closure System in the patient's ASD and PDA, closure (residual shunt < 3mm) at 6 months. | 6 months |