Hyperion™ International Registry Trial

Patent Ductus Arteriosus Clinical Trial

— COM-01  

Official title:

A Prospective, Multi-center Study to Evaluate the Safety and Performance of the Hyperion™ ASD and PDA Closure Systems.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02220270
• Other study ID #: COM-01 V1.0 17 June 2014
• Status: Recruiting
• Phase: N/A
• First received: August 14, 2014
• Last updated: August 17, 2015
• Start date: May 2015
• Est. completion date: August 2017

Study information

• Verified date: August 2015
• Source: European Cardiovascular Research Center
• Contact: Jean-François Piechaud, MD
• Phone: 0 60 13 46 20
• Email: jfpiechaud[@]angio-icps.com
• Is FDA regulated: No
• Health authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé,Commission nationale de l'informatique et des libertéAlgérie: Committee for the Protection of PersonnesGermany: Ethik-Kommission der Landesärztekammer Hessen (Committee for the Protection of Personnes )
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 90 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atrial Septal Defects
• Ductus Arteriosus, Patent
• Heart Septal Defects
• Heart Septal Defects, Atrial
• Patent Ductus Arteriosus

Intervention

Device:
• ASD and PDA closure

Locations

Country	Name	City	State
Algeria	CHU Frantz-Fanon	Blida
Algeria	Radjah Clinic	Setif
Algeria	Centre Médico-chirurgical infantile Bou Ismail	Tipaza
China	Anzhen Hospital	Beijing
China	Shanghai Children's Medical Center	Shanghai
France	Hôpital cardiologique Haut-Leveque (CHU Bordeaux)	Bordeaux
France	Hôpital Privé Jacques Cartier	Massy
France	Hopital Necker Enfants Malades	Paris
France	American Memorial Hospital	Reims
Germany	CardioVascular Center Frankfurt	Frankfurt

Sponsors (2)

Lead Sponsor	Collaborator
European Cardiovascular Research Center	Comed B.V.

Countries where clinical trial is conducted

Algeria,  China,  France,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	No
Secondary	Major Adverse Events	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.	30 days, 6 and 12 months	Yes
Secondary	Procedure success	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.	6 months	No