Hyperion™ International Registry Trial | NCT02220270

NCT02220270

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
Comed B.V.	INDUSTRY

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Label	Type	Description	Intervention Names
patient with PDA or ASD			Device: ASD and PDA closure

Name	Type	Description	Arm Group Labels	Other Names
ASD and PDA closure	Device		patient with PDA or ASD

Outcomes Module

Primary Outcomes

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 Outcomes

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

Eligibility Module

Eligibility Criteria

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

ID	Term
D006344	Heart Septal Defects, Atrial
D004374	Ductus Arteriosus, Patent

ID	Term
D006343	Heart Septal Defects
D006330	Heart Defects, Congenital
D018376	Cardiovascular Abnormalities
D002318	Cardiovascular Diseases