Brief Title
Hyperion™ International Registry Trial
Official Title
A Prospective, Multi-center Study to Evaluate the Safety and Performance of the Hyperion™ ASD and PDA Closure Systems.
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.
Study Type
Observational
Primary Outcome
Success of implantation
Secondary Outcome
Major Adverse Events
Condition
Atrial Septal Defects
Intervention
ASD and PDA closure
Study Arms / Comparison Groups
patient with PDA or ASD
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
200
Start Date
May 2015
Completion Date
August 2017
Primary Completion Date
November 2016
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
Gender
All
Ages
1 Year - 90 Years
Accepts Healthy Volunteers
No
Contacts
, 0 60 13 46 20, [email protected]
Location Countries
Algeria
Location Countries
Algeria
Administrative Informations
NCT ID
NCT02220270
Organization ID
COM-01 V1.0 17 June 2014
Responsible Party
Sponsor
Study Sponsor
European Cardiovascular Research Center
Collaborators
Comed B.V.
Study Sponsor
, ,
Verification Date
August 2015