Clinical trial NCT02220270: 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.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Septal Defects
Patent Ductus Arteriosus
Lead sponsor: European Cardiovascular Research Center
Sponsor class: NETWORK
Collaborators: name: Comed B.V.
First posted: 2014-08-19
Enrollment: 200
Sex: ALL
Minimum age (years): 1
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient who comes to hospital for ASD or PDA closure

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 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

Primary outcomes:
measure: Success of implantation
timeFrame: 30 days
measure: Device success
timeFrame: 6 months
Secondary outcomes:
measure: Major Adverse Events
timeFrame: 30 days, 6 and 12 months
measure: Procedure success
timeFrame: 6 months
Other outcomes:
Locations:
city: Blida
country: Algeria
facility: CHU Frantz-Fanon
city: Setif
country: Algeria
facility: Radjah Clinic
city: Tipaza
country: Algeria
facility: Centre Médico-chirurgical infantile Bou Ismail
city: Beijing
country: China
facility: Anzhen Hospital
city: Shanghai
country: China
facility: Shanghai Children's Medical Center
city: Bordeaux
country: France
facility: Hôpital cardiologique Haut-Leveque (CHU Bordeaux)
city: Massy
country: France
facility: Hôpital Privé Jacques Cartier
city: Paris
country: France
facility: Hopital Necker Enfants Malades
city: Reims
country: France
facility: American Memorial Hospital
city: Frankfurt
country: Germany
facility: CardioVascular Center Frankfurt
Study officials:
References: