Atrial Septal DefectsCOM-01NCT02220270
Hyperion™ International Registry Trial
An observational study of Atrial Septal Defects and Patent Ductus Arteriosus, run by European Cardiovascular Research Center at 10 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 1 year to 90 years
- Conditions the study is for
- Atrial Septal Defects, Patent Ductus Arteriosus
- What is being tested?
- ASD and PDA closure
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 10 sitesin 4 countries
- Study dates
- May 2015to Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patient who comes to hospital for ASD or PDA closure
Who may be able to join
- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
10 sites in 4 countries.
10 sites in 4 countries
France4 sites, 4 recruiting
- Not yet recruiting
Hôpital cardiologique Haut-Leveque (CHU Bordeaux)
Bordeaux, 33604
Jean-Benoit Thambo, jean-benoit.thambo@chu-bordeaux.fr
Jean-Benoit Thambo, MD
- Recruiting
Hôpital Privé Jacques Cartier
Massy, 91300
Jean-François Piechaud, MD, Piechjfpiechaud@angio-icps.com
Jean-François Piechaud, MD
- Recruiting
Hopital Necker Enfants Malades
Paris, 75015
Younes Boudjemline, MD, yboudjemline@yahoo.fr
Younes Boudjemline, MD
- Not yet recruiting
American Memorial Hospital
Reims, 51100
Pierre Mauran, pmauran@chu-reims.fr
Pierre Mauran, MD
Algeria3 sites, 3 recruiting
- Recruiting
CHU Frantz-Fanon
Blida
Mohamed Chettibi, MD, med.chettibi@yahoo.fr
- Not yet recruiting
Radjah Clinic
Sétif
Jean-François Peichaud
Jean-François Piechaud
- Recruiting
Centre Médico-chirurgical infantile Bou Ismail
Tipasa
Mohamed Touati, MD, mohamedtouati@hotmail.com
China2 sites, 2 recruiting
- Not yet recruiting
Anzhen Hospital
Beijing
Hong Gu, MD
- Not yet recruiting
Shanghai Children's Medical Center
Shanghai
Fen Li, MD
Germany1 site, 1 recruiting
- Recruiting
CardioVascular Center Frankfurt
Frankfurt, 60389
Horst SIEVERT, horstsievertmd@aol.com
Horst Sievert, MD
About this study
Official title: A Prospective, Multi-center Study to Evaluate the Safety and Performance of the Hyperion™ ASD and PDA Closure Systems.
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.
- Conditions
- Atrial Septal Defects, Patent Ductus Arteriosus
- Being tested
- ASD and PDA closure
- Medical subject headings
- Heart Septal Defects, Atrial, Ductus Arteriosus, Patent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASD and PDA closureDevice
| Study group | Role | What they receive |
|---|---|---|
| patient with PDA or ASD | Not described Receives: Device: ASD and PDA closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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).
Measured: 6 months
Secondary outcomes (2)
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.
Measured: 30 days, 6 and 12 months
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2014 (estimated)
- Study startMay 2015
- Primary completionNov 2016 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Septal DefectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Cardiovascular Research Center
- Sponsor type
- Research network
- Collaborators
- Comed B.V.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02220270
- Sponsor's protocol ID
- COM-01 V1.0 17 June 2014
- Acronym
- COM-01
- Status last verified
- Aug 2015
- First submitted
- 14 Aug 2014
- Last updated
- 19 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center Study to Evaluate the Safety and Performance of the Hyperion™ ASD and PDA Closure Systems.
- ClinicalTrials.gov ID
- NCT02220270
- Acronym / sponsor ID
- COM-01 / COM-01 V1.0 17 June 2014
- Conditions
- Atrial Septal Defects, Patent Ductus Arteriosus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- European Cardiovascular Research CenterResearch network
- Collaborators
- Comed B.V.
- Study start
- May 2015
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 19 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient with PDA or ASD | – | Device: ASD and PDA closure |
Who may qualify
- Ages
- 1 year to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient who comes to hospital for ASD or PDA closure
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASD and PDA closure | Device | patient with PDA or ASD |
Primary outcome
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
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).
2 secondary outcomes
Major Adverse Events
Time frame: 30 days, 6 and 12 months
Procedure success
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
10 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Septal Defects and Patent Ductus Arteriosus, run by European Cardiovascular Research Center at 10 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France, Algeria, China, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-François Piechaud, MD (0 60 13 46 20 ext. 33, jfpiechaud@angio-icps.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success of implantation (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2015.