Heart Septal Defects, Ventricularpfm-01/2005NCT00390702
Safety and Effectiveness of the Nit-Occlud® Lê VSD Spiral Coil System
A study testing transcatheter implantation of a VSD occluder (Nitinol coil) in people with Heart Septal Defects, Ventricular, run by pfm medical gmbh at 6 sites in 2 countries.
Trial summary
The Ventricular septal defect (VSD) is the most common of all congenital cardiac malformations. By modifying the Nit-Occlud® PDA Device the Nit-Occlud® Lê VSD Spiral System was designed. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Heart Septal Defects, Ventricular
- What is being tested?
- transcatheter implantation of a VSD occluder (Nitinol coil)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Oct 2006to May 2017
- Phase
- Interventional
- 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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- VSD must be diagnosed by acknowledged methods, like echocardiography
- Signs of left ventricular volume overload are present (left ventricle or left atrium diameters 2 standard deviations greater than normal) and/or measured by catheterisation : Qp/Qs > 1.5
- Pulmonary vascular resistance is less than 4 Wood units
- The patient is older than 24 months
- The VSD has a perimembranous or muscular location.
- A distance between the rim of the VSD and the aortic annulus of at least 3.0 mm (as measured on the 2-D echocardiography - apical 5-chamber view)
- The minimal diameter (size) of the VSD is less than 8.0 mm (as measured on the 2-D echocardiography - apical 5-chamber view)
- Patient must agree to fully participate in the clinical trial and give informed consent in writing. If the patient is without legal ability additionally the person of legal responsibility must agree and s/he must give the informed consent in writing
Who cannot join
- Pathological or physical condition precluding the implantation of a Nit-Occlud® Lê VSD coil, such as :
- perimembranous VSD with no evidence of circular aneurysm formation
- Associated cardiac anomalies requiring surgery (greater than mild aortic insufficiency; such as aortic valve prolapse)
- Active endocarditis or other type of sepsis or other active infection at time of implantation
- Thrombus at or near the intended site of implantation
- Thrombus in the vessels through which access to the VSD is gained (unless the patient is protected with an embolic protection device such as a vena cava filter)
Show all 20Show fewer
- Vessels through which access to the VSD is gained can not accommodate a 7 F sheath
- Potential steric (3-dimensional) interference of the occluder with intracardiac or intravascular structures (like valves)
- History of blood disorder (coagulopathy, tendency towards haemolysis)
- History of hypersensitivity to contrast medium or Nitinol
- AV-block II° or III°, atrial fibrillation, or atrial flutter
- End stage cardiac disease, irreversible major organ failure, or terminal cancer
- HIV infection
- Cerebrovascular disease or neurological deterioration
- Emergency cardiologic intervention
- Patient*) is not able to fully participate in this study including all follow-ups (e.g. for mental or geographical reasons, or patient is intravenous drug user or has strong potential for non-compliance to medical regimes)
- Patient, respectively the person of legal responsibility, is mentally unable to understand the nature, aims, or possible consequences of the clinical investigation
- Pregnant or breast-feeding women
- Patient did participate in another clinical investigation during the last 3 months
- Patient or the person of responsibility has revoked the consent.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Germany5 sites
Dept. Congem.Heart Defects, Deutsches Herzzentrum
Berlin, 13353
Cardio-Vascular Centre, Sankt Kathrinen
Frankfurt, 60389
Univ.Klinikum, Zentrum fuer Kinderheilkunde
Giessen, 35390
Dept. Paediatric Cardiology, Univ. Hospital Hamburg
Hamburg, 20246
Dept. Paediatric Cardiology, Univ. Clinic Grosshadern
Munich, 81377
About this study
Official title: International Multicentre Clinical Device Investigation on Safety and Effectiveness of the Nit-Occlud® Lê VSD Spiral Coil System for VSD Occlusion Developed by Pfm AG, Cologne
The Ventricular septal defect (VSD) is the most common of all congenital cardiac malformations. By modifying the Nit-Occlud® PDA Device the Nit-Occlud® Lê VSD Spiral System was designed. as a percutaneous, transcatheter device for occlusion of (peri)membranous and muscular ventricular septum defects (VSD) with a spiral coil. In this clinical investigation feasibility, safety and performance of the new cardiac occluder will be evaluated in accordance with European and US regulations. The study data will be compared to performance criteria for VSD, which are deduced analogue to the published specific Objective Performance Criteria (OPCs) for PDAs. The first part of the study has been performed in three clinical centres in Germany. For the second part in April 2009 four additional clinical centres in Germany, Israel, Italy and Spain were included.
- Conditions
- Heart Septal Defects, Ventricular
- Being tested
- transcatheter implantation of a VSD occluder (Nitinol coil)
- Keywords
- Ventricular septal defect, VSD
- Medical subject headings
- Heart Septal Defects, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcatheter implantation of a VSD occluder (Nitinol coil)Device
Also called Nit-Occlud® Lê VSD Occluder
transcatheter implantation, by first performing a arterial-venous loop through the defect
| Study group | Role | What they receive |
|---|---|---|
| VSD occluder | Experimental | transcatheter implantation of a VSD occluder (Nitinol coil) Receives: Device: transcatheter implantation of a VSD occluder (Nitinol coil) |
What is being measured
The primary outcome is the main question the study is designed to answer.
a set of Performance Criteria (PC) deduced for VSD analogue to the set of Objective Performance Criteria (OPC) of the 'Multiorganization Advisory Panel to FDA for Pediatric Cardiovascular Devices' for PDAs
Measured: Five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2006 (estimated)
- Study startOct 2006
- Primary completionAug 2012
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Septal Defects, VentricularStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- pfm medical gmbh
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Aix Scientifics
- Responsible party
- Sponsor
- Investigators
- Thomas Meinertz, Prof Dr med, Principal investigator, University Hospital Hamburg Eppendorf, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00390702
- Sponsor's protocol ID
- pfm 01/2005
- Acronym
- pfm-01/2005
- Status last verified
- Nov 2018
- First submitted
- 19 Oct 2006
- Last updated
- 7 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Multicentre Clinical Device Investigation on Safety and Effectiveness of the Nit-Occlud® Lê VSD Spiral Coil System for VSD Occlusion Developed by Pfm AG, Cologne
- ClinicalTrials.gov ID
- NCT00390702
- Acronym / sponsor ID
- pfm-01/2005 / pfm 01/2005
- Conditions
- Heart Septal Defects, Ventricular
- Keywords
- Ventricular septal defect, VSD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- pfm medical gmbhIndustry (pharma, biotech, devices)
- Collaborators
- Aix Scientifics
- Study start
- Oct 2006 (actual)
- Primary completion
- Aug 2012 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 20 Oct 2006 (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 Ventricular septal defect (VSD) is the most common of all congenital cardiac malformations. By modifying the Nit-Occlud® PDA Device the Nit-Occlud® Lê VSD Spiral System was designed. as a percutaneous, transcatheter device for occlusion of (peri)membranous and muscular ventricular septum defects (VSD) with a spiral coil. In this clinical investigation feasibility, safety and performance of the new cardiac occluder will be evaluated in accordance with European and US regulations. The study data will be compared to performance criteria for VSD, which are deduced analogue to the published specific Objective Performance Criteria (OPCs) for PDAs. The first part of the study has been performed in three clinical centres in Germany. For the second part in April 2009 four additional clinical centres in Germany, Israel, Italy and Spain were included.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VSD occluder | Experimental | Device: transcatheter implantation of a VSD occluder (Nitinol coil)transcatheter implantation of a VSD occluder (Nitinol coil) |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- VSD must be diagnosed by acknowledged methods, like echocardiography
- Signs of left ventricular volume overload are present (left ventricle or left atrium diameters 2 standard deviations greater than normal) and/or measured by catheterisation : Qp/Qs > 1.5
- Pulmonary vascular resistance is less than 4 Wood units
- The patient is older than 24 months
- The VSD has a perimembranous or muscular location.
Key exclusion criteria (20 listed)
- Pathological or physical condition precluding the implantation of a Nit-Occlud® Lê VSD coil, such as :
- perimembranous VSD with no evidence of circular aneurysm formation
- Associated cardiac anomalies requiring surgery (greater than mild aortic insufficiency; such as aortic valve prolapse)
- Active endocarditis or other type of sepsis or other active infection at time of implantation
- Thrombus at or near the intended site of implantation
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 |
|---|---|---|
| transcatheter implantation of a VSD occluder (Nitinol coil)Also: Nit-Occlud® Lê VSD Occludertranscatheter implantation, by first performing a arterial-venous loop through the defect | Device | VSD occluder |
Primary outcome
a set of Performance Criteria (PC) deduced for VSD analogue to the set of Objective Performance Criteria (OPC) of the 'Multiorganization Advisory Panel to FDA for Pediatric Cardiovascular Devices' for PDAs
Time frame: Five years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2018.
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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.
Thomas Meinertz, Prof Dr med principal investigator
University Hospital Hamburg Eppendorf, Germany
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcatheter implantation of a VSD occluder (Nitinol coil) in people with Heart Septal Defects, Ventricular, run by pfm medical gmbh at 6 sites in 2 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 8 inclusion and 20 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: finished, as of the sponsor's last update on 7 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany, Israel. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
a set of Performance Criteria (PC) deduced for VSD analogue to the set of Objective Performance Criteria (OPC) of the 'Multiorganization Advisory Panel to FDA for Pediatric Cardiovascular Devices' for PDAs (time frame: Five years). 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 7 Nov 2018.