Congenital Heart DefectMRWIREPMCFNCT02493634
Post-market Clinical Follow-up Study With Magnetic Resonance Imaging Conditional Guide Wire
A study testing pressure gradient measurement and MRWire in people with Congenital Heart Defect, run by Nano4Imaging GmbH at 3 sites in 2 countries.
Trial summary
This is post-market clinical follow-up study on 25 consecutive patients in two centers to evaluate the safety and performance of magnetic resonance imaging conditional guide wire and the acceptability of identified risks in the clinical evaluation and to detect emerging risks on the basis of factorial evidence.The… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Congenital Heart Defect
- What is being tested?
- pressure gradient measurement and MRWire
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Aug 2015to 29 Mar 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients with clinical indication for cardiac magnetic resonance and conventional diagnostic catheterisation
- patients with body weight of > 40 kg in which the introduction of an introducer of > 5 French is possible.
- subject provided written informed consent using the approved consent form or in case of a minor the subject provided written assent and its legal guardian provided written informed consent.
Who cannot join
- major surgery in the last 42 days
- history of irreversible bleeding disorder
- contraindication to cardiac magnetic resonance
- Contraindications to guidewire procedures, such as evidence of active infection
- women of child-bearing potential who cannot provide a negative pregnancy test
- chronic total occlusion.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Germany2 sites
Herzzentrum Leipzig
Leipzig, 04289
Deutsches Herzzentrum Munchen
Munich, Bavaria, 80636
United Kingdom1 site
Royal Free Hospital- Great Ormond Street Hospital
London, WC1N 1EH
About this study
This is post-market clinical follow-up study on 25 consecutive patients in two centers to evaluate the safety and performance of magnetic resonance imaging conditional guide wire and the acceptability of identified risks in the clinical evaluation and to detect emerging risks on the basis of factorial evidence.The procedure will be done in patients with a clinical indication for cardiac magnetic resonance and conventional catheterisation.
Read the detailed description
This is post-market clinical follow-up study on 25 consecutive patients in two centers to evaluate the safety of a guide wire conditional for use in magnetic resonance imaging and the acceptability of identified risks in the clinical evaluation and to detect emerging risks on the basis of factorial evidence.
The guidewire is used to access the patients central circulatory system and in particular for the introduction and exact placement of a pressure catheter to measure the pressure gradient over the aortic arch. The procedure will be done in patients with a clinical indication for cardiac magnetic resonance and conventional catheterisation.Patients need to have a body weight over 40 kg and the introduction of a 5 French catheter should be possible. The primary endpoint is the measurement of procedural success, defined as successful insertion, steerability and visibility in MRI, in the absence of device related adverse events such as damage to vessel wall. In addition structural integrity of the instruments is to be assessed.
- Conditions
- Congenital Heart Defect
- Being tested
- pressure gradient measurement, MRWire
- Keywords
- Magnetic Resonance spectroscopy, Aortic Arch
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pressure gradient measurementProcedure or surgery
Also called MRWire
A guidewire is used to introduce and position a pressure catheter under magnetic resonance guidance to conduct flow and pressure measurement in the aortic arch to evaluate vascular resistance.
MRWireDevice
| Study group | Role | What they receive |
|---|---|---|
| pressure gradient measurement | Other | Diagnostic procedure to measure pressure gradient in series of patients. Focus is on safety and absence of adverse events Receives: Procedure: pressure gradient measurement; Device: MRWire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural success
procedural success means that insertion, steerability and visibility of the guide wire in the MR guided intervention was successfully reached, in the absence of adverse events up to 30 days after procedure
Measured: Up to 30 days after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2015 (estimated)
- Study startAug 2015
- Primary completion18 Jan 2017
- Study completion29 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DefectStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nano4Imaging GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CERES GmbH
- Responsible party
- Sponsor
- Investigators
- Peter Ewert, Prof, MD, Principal investigator, German Heart Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02493634
- Sponsor's protocol ID
- N4IPMCF2015
- Acronym
- MRWIREPMCF
- Status last verified
- Mar 2018
- First submitted
- 22 Jun 2015
- Last updated
- 30 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Kos S, Huegli R, Hofmann E, Quick HH, Kuehl H, Aker S, Kaiser GM, Borm PJ, Jacob AL, Bilecen D. First magnetic resonance imaging-guided aortic stenting and cava filter placement using a polyetheretherketone-based magnetic resonance imaging-compatible guidewire in swine: proof of concept. Cardiovasc Intervent Radiol. 2009 May;32(3):514-21. doi: 10.1007/s00270-008-9483-5. Epub 2008 Dec 30.
PubMed 19115070Kos S, Huegli R, Hofmann E, Quick HH, Kuehl H, Aker S, Kaiser GM, Borm PJ, Jacob AL, Bilecen D. MR-compatible polyetheretherketone-based guide wire assisting MR-guided stenting of iliac and supraaortic arteries in swine: feasibility study. Minim Invasive Ther Allied Technol. 2009;18(3):181-8. doi: 10.1080/13645700902921971.
PubMed 19431070Kos S, Huegli R, Hofmann E, Quick HH, Kuehl H, Aker S, Kaiser GM, Borm PJ, Jacob AL, Bilecen D. Feasibility of real-time magnetic resonance-guided angioplasty and stenting of renal arteries in vitro and in Swine, using a new polyetheretherketone-based magnetic resonance-compatible guidewire. Invest Radiol. 2009 Apr;44(4):234-41. doi: 10.1097/RLI.0b013e31819b00f1.
PubMed 19252440
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-market Clinical Follow-up Study With Magnetic Resonance Imaging Conditional Guide Wire
- ClinicalTrials.gov ID
- NCT02493634
- Acronym / sponsor ID
- MRWIREPMCF / N4IPMCF2015
- Conditions
- Congenital Heart Defect
- Keywords
- Magnetic Resonance spectroscopy, Aortic Arch
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Nano4Imaging GmbHIndustry (pharma, biotech, devices)
- Collaborators
- CERES GmbH
- Study start
- Aug 2015
- Primary completion
- 18 Jan 2017 (actual)
- Study completion
- 29 Mar 2017 (actual)
- First posted
- 9 Jul 2015 (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.
This is post-market clinical follow-up study on 25 consecutive patients in two centers to evaluate the safety and performance of magnetic resonance imaging conditional guide wire and the acceptability of identified risks in the clinical evaluation and to detect emerging risks on the basis of factorial evidence.The procedure will be done in patients with a clinical indication for cardiac magnetic resonance and conventional catheterisation.
Detailed description
This is post-market clinical follow-up study on 25 consecutive patients in two centers to evaluate the safety of a guide wire conditional for use in magnetic resonance imaging and the acceptability of identified risks in the clinical evaluation and to detect emerging risks on the basis of factorial evidence.
The guidewire is used to access the patients central circulatory system and in particular for the introduction and exact placement of a pressure catheter to measure the pressure gradient over the aortic arch. The procedure will be done in patients with a clinical indication for cardiac magnetic resonance and conventional catheterisation.Patients need to have a body weight over 40 kg and the introduction of a 5 French catheter should be possible. The primary endpoint is the measurement of procedural success, defined as successful insertion, steerability and visibility in MRI, in the absence of device related adverse events such as damage to vessel wall. In addition structural integrity of the instruments is to be assessed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pressure gradient measurement | Other | Procedure: pressure gradient measurement, Device: MRWireDiagnostic procedure to measure pressure gradient in series of patients. Focus is on safety and absence of adverse events |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- patients with clinical indication for cardiac magnetic resonance and conventional diagnostic catheterisation
- patients with body weight of > 40 kg in which the introduction of an introducer of > 5 French is possible.
- subject provided written informed consent using the approved consent form or in case of a minor the subject provided written assent and its legal guardian provided written informed consent.
Key exclusion criteria (6 listed)
- major surgery in the last 42 days
- history of irreversible bleeding disorder
- contraindication to cardiac magnetic resonance
- Contraindications to guidewire procedures, such as evidence of active infection
- women of child-bearing potential who cannot provide a negative pregnancy test
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 |
|---|---|---|
| pressure gradient measurementAlso: MRWireA guidewire is used to introduce and position a pressure catheter under magnetic resonance guidance to conduct flow and pressure measurement in the aortic arch to evaluate vascular resistance. | Procedure or surgery | pressure gradient measurement |
| MRWire | Device | pressure gradient measurement |
Primary outcome
Procedural success
Time frame: Up to 30 days after procedure
procedural success means that insertion, steerability and visibility of the guide wire in the MR guided intervention was successfully reached, in the absence of adverse events up to 30 days after procedure
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 30 Mar 2018.
- Background: PubMed 19115070Kos S, Huegli R, Hofmann E, Quick HH, Kuehl H, Aker S, Kaiser GM, Borm PJ, Jacob AL, Bilecen D. First magnetic resonance imaging-guided aortic stenting and cava filter placement using a polyetheretherketone-based magnetic resonance imaging-compatible guidewire in swine: proof of concept. Cardiovasc Intervent Radiol. 2009 May;32(3):514-21. doi: 10.1007/s00270-008-9483-5. Epub 2008 Dec 30.
- Background: PubMed 19431070Kos S, Huegli R, Hofmann E, Quick HH, Kuehl H, Aker S, Kaiser GM, Borm PJ, Jacob AL, Bilecen D. MR-compatible polyetheretherketone-based guide wire assisting MR-guided stenting of iliac and supraaortic arteries in swine: feasibility study. Minim Invasive Ther Allied Technol. 2009;18(3):181-8. doi: 10.1080/13645700902921971.
- Background: PubMed 19252440Kos S, Huegli R, Hofmann E, Quick HH, Kuehl H, Aker S, Kaiser GM, Borm PJ, Jacob AL, Bilecen D. Feasibility of real-time magnetic resonance-guided angioplasty and stenting of renal arteries in vitro and in Swine, using a new polyetheretherketone-based magnetic resonance-compatible guidewire. Invest Radiol. 2009 Apr;44(4):234-41. doi: 10.1097/RLI.0b013e31819b00f1.
- Individual participant dataSharing planned: Undecided
Related trials for Congenital Heart Defect
Not yet recruiting
Autologous Thymus Transplant in Children With Congenital Heart Disease: A Pilot Study
Congenital Heart Disease (CHD)
RecruitingObservational study
A 10-Minute Cardiovascular Magnetic Resonance Protocol for Cardiac Disease
Coronary Artery Disease, Myocarditis
Active, not recruiting
Learning by Heart: The Effectiveness of an EF Training Program for Pre-schoolers With Critical CHD
Congenital Heart Disease, Executive Dysfunction
Not yet recruiting
UltraTrac for Cardiac Output Monitoring in Congenital Heart Disease
Congenital Heart Disease, Cardiac Output
RecruitingPhase 1/2
Butyric Acid Supplementation for Gut Improvement After Cardiac Surgery in Kids
Congenital Heart Disease (CHD)
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.
Peter Ewert, Prof, MD principal investigator
German Heart Center
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pressure gradient measurement and MRWire in people with Congenital Heart Defect, run by Nano4Imaging GmbH at 3 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 3 inclusion and 6 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 30 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, United Kingdom. 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?
Procedural success (time frame: Up to 30 days after procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02493634, which also lists 3 linked publications.
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 30 Mar 2018.