Status:
UNKNOWN
Hyperion™ International Registry Trial
Lead Sponsor:
European Cardiovascular Research Center
Collaborating Sponsors:
Comed B.V.
Conditions:
Atrial Septal Defects
Patent Ductus Arteriosus
Eligibility:
All Genders
1-90 years
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2015
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2017
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT02220270
Start Date
May 1 2015
End Date
August 1 2017
Last Update
August 19 2015
Active Locations (10)
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1
CHU Frantz-Fanon
Blida, Algeria
2
Radjah Clinic
Sétif, Algeria
3
Centre Médico-chirurgical infantile Bou Ismail
Tipasa, Algeria
4
Anzhen Hospital
Beijing, China