Hyperion™ International Registry Trial

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 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

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