NCT02220270

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2015

Typical duration for all trials

Geographic Reach
4 countries

10 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 19, 2014

Completed
9 months until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

August 19, 2015

Status Verified

August 1, 2015

Enrollment Period

1.5 years

First QC Date

August 14, 2014

Last Update Submit

August 17, 2015

Conditions

Atrial Septal DefectsPatent Ductus Arteriosus

Outcome Measures

Primary Outcomes (2)

  • Success of implantation

    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

    30 days

  • Device success

    Device success defined as ASD or PDA closure at 6 months post procedure by a Transthoracic echocardiography (TTE) or a Transesophageal echocardiography (TEE).

    6 months

Secondary Outcomes (2)

  • Major Adverse Events

    30 days, 6 and 12 months

  • Procedure success

    6 months

Study Arms (1)

patient with PDA or ASD

Device: ASD and PDA closure

Interventions

ASD and PDA closureDEVICE
patient with PDA or ASD

Eligibility Criteria

Age1 Year - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient who comes to hospital for ASD or PDA closure

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

CHU Frantz-Fanon

Blida, Algeria

RECRUITING

Radjah Clinic

Sétif, Algeria

NOT YET RECRUITING

Centre Médico-chirurgical infantile Bou Ismail

Tipasa, Algeria

RECRUITING

Anzhen Hospital

Beijing, China

NOT YET RECRUITING

Shanghai Children's Medical Center

Shanghai, China

NOT YET RECRUITING

Hôpital cardiologique Haut-Leveque (CHU Bordeaux)

Bordeaux, 33604, France

NOT YET RECRUITING

Hôpital Privé Jacques Cartier

Massy, 91300, France

RECRUITING

Hopital Necker Enfants Malades

Paris, 75015, France

RECRUITING

American Memorial Hospital

Reims, 51100, France

NOT YET RECRUITING

CardioVascular Center Frankfurt

Frankfurt, 60389, Germany

RECRUITING

MeSH Terms

Conditions

Heart Septal Defects, AtrialDuctus Arteriosus, Patent

Condition Hierarchy (Ancestors)

Heart Septal DefectsHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Jean-François Piechaud, MD

CONTACT

0 60 13 46 20jfpiechaud@angio-icps.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2014

First Posted

August 19, 2014

Study Start

May 1, 2015

Primary Completion

November 1, 2016

Study Completion

August 1, 2017

Last Updated

August 19, 2015

Record last verified: 2015-08

Locations

DE(1)AL(3)FR(4)CN(2)