COM-01: Hyperion™ International Registry Trial
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| patient with PDA or ASD
|
Device: ASD and PDA closure
|
Outcome Measures
Primary Outcome Measures
- Success of implantation [30 days]
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
- Device success [6 months]
Device success defined as ASD or PDA closure at 6 months post procedure by a Transthoracic echocardiography (TTE) or a Transesophageal echocardiography (TEE).
Secondary Outcome Measures
- Major Adverse Events [30 days, 6 and 12 months]
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.
- Procedure success [6 months]
Procedure success defined as successful deployment of the Hyperion™ Closure System in the patient's ASD and PDA, closure (residual shunt < 3mm) at 6 months.
Eligibility Criteria
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
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For ASD: Patient weighting ≥15 kg of any age
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Patient is willing and able to comply with specified follow-up evaluations
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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:
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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
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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)
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Patient has a known hypersensitivity or contraindication to aspirin, heparin, and/or contrast sensitivity that cannot be adequately pre-medicated
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Currently participating in another clinical study
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Active endocarditis, active bacterial infection, or other infection producing bacteremia or sepsis
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Congenital or structural heart disease other than ASD or PDA
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Thrombus at the intended site of implant or documented venous thrombosis in venous access
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Severe pulmonary hypertension
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Vascular anatomy unable to accommodate the appropriate-sized sheath for device introduction
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ASD or PDA anatomy non suitable for the Hyperion™ closure device
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Confinement to bed (increased risk for clot formation)
-
Prior cardiac implantation of cardiac devices for ASD or PDA closure
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU Frantz-Fanon | Blida | Algeria | ||
| 2 | Radjah Clinic | Setif | Algeria | ||
| 3 | Centre Médico-chirurgical infantile Bou Ismail | Tipaza | Algeria | ||
| 4 | Anzhen Hospital | Beijing | China | ||
| 5 | Shanghai Children's Medical Center | Shanghai | China | ||
| 6 | Hôpital cardiologique Haut-Leveque (CHU Bordeaux) | Bordeaux | France | 33604 | |
| 7 | Hôpital Privé Jacques Cartier | Massy | France | 91300 | |
| 8 | Hopital Necker Enfants Malades | Paris | France | 75015 | |
| 9 | American Memorial Hospital | Reims | France | 51100 | |
| 10 | CardioVascular Center Frankfurt | Frankfurt | Germany | 60389 |
Sponsors and Collaborators
- European Cardiovascular Research Center
- Comed B.V.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- COM-01 V1.0 17 June 2014