Hyperion™ International Registry Trial (COM-01)

European Cardiovascular Research Institute (ECRI)

Status: Unknown

Conditions: Atrial Septal Defects; Patent Ductus Arteriosus

Treatments: Device: ASD and PDA closure

Study type: Observational

Funder types: NETWORK; Industry

Identifiers

NCT02220270

COM-01 V1.0 17 June 2014

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 1 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 1 patient group

patient with PDA or ASD

Treatment:

Device: ASD and PDA closure