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Hyperion™ International Registry Trial (COM-01)

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ClinicalTrials.gov Identifier: NCT02220270
Recruitment Status : Unknown
Verified August 2015 by European Cardiovascular Research Center.
Recruitment status was:  Recruiting
First Posted : August 19, 2014
Last Update Posted : August 19, 2015
Sponsor:
Collaborator:
Comed B.V.
Information provided by (Responsible Party):
European Cardiovascular Research Center

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
Atrial Septal Defects Patent Ductus Arteriosus Device: ASD and PDA closure

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Multi-center Study to Evaluate the Safety and Performance of the Hyperion™ ASD and PDA Closure Systems.
Study Start Date : May 2015
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
patient with PDA or ASD Device: ASD and PDA closure



Primary Outcome Measures :
  1. Success of implantation [ Time Frame: 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

  2. Device success [ Time Frame: 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 :
  1. Major Adverse Events [ Time Frame: 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.

  2. Procedure success [ Time Frame: 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.



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Ages Eligible for Study:   1 Year to 90 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient who comes to hospital for ASD or PDA closure
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02220270


Contacts
Contact: Jean-François Piechaud, MD 0 60 13 46 20 ext 33 jfpiechaud@angio-icps.com

Locations
Algeria
CHU Frantz-Fanon Recruiting
Blida, Algeria
Contact: Mohamed Chettibi, MD       med.chettibi@yahoo.fr   
Radjah Clinic Not yet recruiting
Setif, Algeria
Contact: Jean-François Peichaud         
Principal Investigator: Jean-François Piechaud         
Centre Médico-chirurgical infantile Bou Ismail Recruiting
Tipaza, Algeria
Contact: Mohamed Touati, MD       mohamedtouati@hotmail.com   
China
Anzhen Hospital Not yet recruiting
Beijing, China
Contact: Hong Gu, MD         
Shanghai Children's Medical Center Not yet recruiting
Shanghai, China
Contact: Fen Li, MD         
France
Hôpital cardiologique Haut-Leveque (CHU Bordeaux) Not yet recruiting
Bordeaux, France, 33604
Contact: Jean-Benoit Thambo       jean-benoit.thambo@chu-bordeaux.fr   
Principal Investigator: Jean-Benoit Thambo, MD         
Hôpital Privé Jacques Cartier Recruiting
Massy, France, 91300
Contact: Jean-François Piechaud, MD       Piechjfpiechaud@angio-icps.com   
Principal Investigator: Jean-François Piechaud, MD         
Hopital Necker Enfants Malades Recruiting
Paris, France, 75015
Contact: Younes Boudjemline, MD       yboudjemline@yahoo.fr   
Principal Investigator: Younes Boudjemline, MD         
American Memorial Hospital Not yet recruiting
Reims, France, 51100
Contact: Pierre Mauran       pmauran@chu-reims.fr   
Principal Investigator: Pierre Mauran, MD         
Germany
CardioVascular Center Frankfurt Recruiting
Frankfurt, Germany, 60389
Contact: Horst SIEVERT       horstsievertmd@aol.com   
Principal Investigator: Horst Sievert, MD         
Sponsors and Collaborators
European Cardiovascular Research Center
Comed B.V.

Responsible Party: European Cardiovascular Research Center
ClinicalTrials.gov Identifier: NCT02220270     History of Changes
Other Study ID Numbers: COM-01 V1.0 17 June 2014
First Posted: August 19, 2014    Key Record Dates
Last Update Posted: August 19, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Ductus Arteriosus, Patent
Heart Septal Defects
Heart Septal Defects, Atrial
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities