Heart Defects, CongenitalNCT03405636
Xeltis Pulmonary Valved Conduit Safety and Performance Study
A study testing Xeltis Pulmonary Valved Conduit in people with Heart Defects, Congenital, run by Xeltis at 4 sites in 4 countries.
Trial summary
This is a multi-center prospective, single-arm, non-randomized, open label study to assess safety and performance of the Xeltis Pulmonary Valved Conduit in subjects requiring Right Ventricular Outflow Tract correction or reconstruction due to congenital heart malformations. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Heart Defects, Congenital
- What is being tested?
- Xeltis Pulmonary Valved Conduit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Sep 2020to Oct 2026
- 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 Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patient requiring RVOT reconstruction, suitable for 16 mm or 18 mm valved conduit.
- Male or Female.
- Age < 22 years.
- Right Ventricular to Pulmonary Artery mean gradient > 35mm Hg or moderate or severe Pulmonary regurgitation (≥3+), or have both.
- The patient, and the patient's parent / legal representative where appropriate, has been informed of the nature of the study, agrees to its provisions and has provided written informed consent by signing the approved informed consent form.
- The patient, and the patient's parent / legal representative where appropriate, and the treating physician agree that the subject will return for all required post-procedure follow up visits and the subject will comply with clinical investigation plan required follow-up visits.
Who cannot join
- Need for or presence of prosthetic heart valve at other position
- Need for concomitant surgical procedures (non-cardiac)
- Patients with previously implanted pacemaker (including defibrillators) or mechanical valves
- Active bacterial or viral infection or requiring current antibiotic therapy (if temporary illness, patient may be a candidate 4 weeks after discontinuation of antibiotics)
- Active endocarditis
- Leukopenia, according to local laboratory evaluation of white blood cell count
Show all 20Show fewer
- Acute or chronic anemia, according to local laboratory evaluation of hemoglobin Patients can be transfused to meet eligibility criteria
- Thrombocytopenia, defined as Platelet count < 150,000/mm3 Patients can be transfused to meet eligibility criteria
- Severe chest wall deformity, which would preclude placement of the PV conduit
- Pulmonary hypertension (right ventricular systolic pressure ≥ half of systemic systolic pressure)
- Right ventricular outflow tract aneurysm
- Known hypersensitivity to anticoagulants and antiplatelet drugs and to the device materials
- Immunocompromised patient defined as: autoimmune disease, patients receiving immunosuppressant drugs or immune stimulant drugs
- Patient has chronic inflammatory / autoimmune disease
- Need for emergency cardiac or vascular surgery or intervention
- Major or progressive non-cardiac disease (liver failure, renal failure, cancer) that has a life expectancy of less than one year
- Currently participating, or participated within the last 30 days, in an investigational drug or device study
- Alcohol or drug abuse as defined by DSM IV-TR criteria for substance abuse - this includes the illicit use of cannabis within the last 12 months
- Females who are sexually active and are not willing to use adequate contraceptive precautions for the next 2 years
- Patient has medical, social or psychosocial factors that, in the opinion of the Investigator, could have impact on safety or compliance
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
Hungary1 site
Gottsegen György Hungarian Institute of Cardiology, Paediatric Cardiac Centre
Budapest, H-1096
Malaysia1 site
Institute Jantung Negara, National Heart Institute
Kuala Lumpur
About this study
Official title: Prospective, Non-randomized, Open Label Clinical Study to Assess the Safety and Performance of the Xeltis Pulmonary Valved Conduit in Subjects Undergoing Right Ventricular Outflow Tract (RVOT) Reconstruction
This is a multi-center prospective, single-arm, non-randomized, open label study to assess safety and performance of the Xeltis Pulmonary Valved Conduit in subjects requiring Right Ventricular Outflow Tract correction or reconstruction due to congenital heart malformations.
- Conditions
- Heart Defects, Congenital
- Being tested
- Xeltis Pulmonary Valved Conduit
- 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.
Xeltis Pulmonary Valved ConduitDevice
RVOT reconstruction
| Study group | Role | What they receive |
|---|---|---|
| Xeltis Pulmonary Valved Conduit | Experimental | PV Conduit for RVOT reconstruction Receives: Device: Xeltis Pulmonary Valved Conduit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival at 12 months follow up post implantation
Measured by the fact that the patient is still alive at the time of the 12 month FU visit
Measured: 12 months
Secondary outcomes (3)
Freedom from device related death, intervention and/or reoperation at 12 months follow up
Measured by the fact that the patient did not die, did not have a reoperation or reintervention during the first 12 months
Measured: 12 months
Mean pressure gradient across the area of conduit implantation (RV to PA) of less than 40 mm Hg at 12 months follow up
Measured: 12 months
Pulmonary regurgitation of equal or less than moderate (≤40 %) at 12 months follow up
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study startSep 2020 (estimated)
- Primary completionOct 2021 (estimated)
- Study completionOct 2026 (estimated)
Why it stopped: Study not started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Defects, CongenitalStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xeltis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03405636
- Sponsor's protocol ID
- XEL-CR-02
- Status last verified
- Apr 2021
- First submitted
- 15 Jan 2018
- Last updated
- 9 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Non-randomized, Open Label Clinical Study to Assess the Safety and Performance of the Xeltis Pulmonary Valved Conduit in Subjects Undergoing Right Ventricular Outflow Tract (RVOT) Reconstruction
- ClinicalTrials.gov ID
- NCT03405636
- Acronym / sponsor ID
- XEL-CR-02
- Conditions
- Heart Defects, Congenital
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study not started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- XeltisIndustry (pharma, biotech, devices)
- Study start
- Sep 2020 (estimated)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 23 Jan 2018 (actual)
- 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 a multi-center prospective, single-arm, non-randomized, open label study to assess safety and performance of the Xeltis Pulmonary Valved Conduit in subjects requiring Right Ventricular Outflow Tract correction or reconstruction due to congenital heart malformations.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Xeltis Pulmonary Valved Conduit | Experimental | Device: Xeltis Pulmonary Valved ConduitPV Conduit for RVOT reconstruction |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Patient requiring RVOT reconstruction, suitable for 16 mm or 18 mm valved conduit.
- Male or Female.
- Age < 22 years.
- Right Ventricular to Pulmonary Artery mean gradient > 35mm Hg or moderate or severe Pulmonary regurgitation (≥3+), or have both.
- The patient, and the patient's parent / legal representative where appropriate, has been informed of the nature of the study, agrees to its provisions and has provided written informed consent by signing the approved informed consent form.
Key exclusion criteria (20 listed)
- Need for or presence of prosthetic heart valve at other position
- Need for concomitant surgical procedures (non-cardiac)
- Patients with previously implanted pacemaker (including defibrillators) or mechanical valves
- Active bacterial or viral infection or requiring current antibiotic therapy (if temporary illness, patient may be a candidate 4 weeks after discontinuation of antibiotics)
- Active endocarditis
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 |
|---|---|---|
| Xeltis Pulmonary Valved ConduitRVOT reconstruction | Device | Xeltis Pulmonary Valved Conduit |
Primary outcome
Survival at 12 months follow up post implantation
Time frame: 12 months
Measured by the fact that the patient is still alive at the time of the 12 month FU visit
3 secondary outcomes
Freedom from device related death, intervention and/or reoperation at 12 months follow up
Time frame: 12 months
Mean pressure gradient across the area of conduit implantation (RV to PA) of less than 40 mm Hg at 12 months follow up
Time frame: 12 months
Pulmonary regurgitation of equal or less than moderate (≤40 %) at 12 months follow up
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Xeltis Pulmonary Valved Conduit in people with Heart Defects, Congenital, run by Xeltis at 4 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 6 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: withdrawn, as of the sponsor's last update on 9 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Hungary, Malaysia, Poland, Slovakia. 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 was withdrawn before enrolling participants, so there are no results.
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?
Survival at 12 months follow up post implantation (time frame: 12 months). 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 9 Apr 2021.