Aortic StenosisNCT04178213
First in Human Feasibility Study With ADAPT 3D - ALR for Aortic Leaflet Repair
A study testing Implantation of ADAPT 3D ALR in people with Aortic Stenosis and Aortic Insufficiency, run by Anteris Technologies Ltd. at 1 site in Belgium.
Trial summary
This study will evaluate the safety and performance of the ADAPT 3D - ALR in adult patients requiring replacement of aortic valve. 15 patients in one site in Belgium will all be treated with ADAPT 3D - ALR. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Aortic Stenosis, Aortic Insufficiency
- What is being tested?
- Implantation of ADAPT 3D ALR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteBelgium
- Study dates
- 26 Mar 2020to Jun 2022
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is older than 18 years of age and ≤ 85 years.
- The subject's aortic annular measurements are ≥ 21 mm to < 27mm as confirmed on pre-op echo.
- The subject is a candidate for Aortic Valve Replacement.
- The subject has documented moderate or severe Aortic Stenosis and/or Aortic Insufficiency (defined as grade 2, 3 or 4).
- The subject is willing and able to comply with specified follow-up requirements and evaluations, including transesophageal echocardiography (TEE) if there are inadequate images by transthoracic echocardiography (TTE) to assess the aortic valve.
- Patient has signed the informed consent
Who cannot join
- All patients who require emergency surgery (within 24 hours of a presentation to an emergency department) for any reason.
- Subject with a pre-existing valve prosthesis in the aortic position.
- Patients requiring repair of other cardiac valves will be excluded.
- Subject with active endocarditis.
- Heavily calcified aortic roots or "porcelain aortas".
- Leukopenia with a WBC (white Blood Cells) of less than 3000.
Show all 18Show fewer
- Acute anaemia with a haemoglobin less than 8 g/dL.
- Platelet count less than 100,000 platelets/microliter, and if less than 150,000 platelets/microliter, platelet reduction of >10,000 platelets/microliter per day over two consecutive days (Note: Where a platelet count is less than 150,000 platelets/microliter but greater than 100,000 platelets/microliter, platelet count testing is to be conducted over 2 consecutive days. If platelets are reducing over those two consecutive days, the rate of reduction in platelets must be less than 10,000 platelets/microliter per day, otherwise the participant must be excluded).
- History of a defined bleeding diathesis or coagulopathy or the subject refuses blood transfusions.
- Active infection requiring antibiotic therapy (if temporary illness, subjects may enroll 2-4 weeks after discontinuation of antibiotics).
- Subjects in whom transesophageal echocardiography (TEE) is contraindicated.
- Low EF < 50 %.
- Life expectancy < 1 year, or severe comorbidities, such as cancer, dialysis, or severe COPD.
- The subject is an illicit drug user, alcohol abuser, prisoner, institutionalised, or is unable to give informed consent.
- The subject is pregnant or lactating (non-pregnancy to be confirmed by pregnancy test for all child bearing potential females).
- Recent (within 6 months) cerebrovascular accident (CVA) or a transient ischemic attack (TIA).
- Myocardial Infarction (MI) within one month of trial inclusion.
- Currently participating in, or have been recently exited from (within 30 days of enrollment in this study), or plan to be enrolled in another clinical
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
University Hospital Leuven
Leuven, 3000
Klaartjie Van den Bossche, +32 16 34 21 60, klaartje.vandenbossche@uzleuven.be
Peter Verbrugghe
About this study
Official title: First in Human Surgical Implantation of Single Piece ADAPT® Treated 3D ALR (Aortic Leaflet Repair), Feasibility and Clinical Safety Study
This study will evaluate the safety and performance of the ADAPT 3D - ALR in adult patients requiring replacement of aortic valve. 15 patients in one site in Belgium will all be treated with ADAPT 3D - ALR.
Read the detailed description
The purpose of this study is to conduct the initial clinical investigation of single piece ADAPT treated 3D - ALR (Aortic Leaflet Repair) to collect evidence on the device's safety and performance. The study is anticipated to confirm successful clinical safety and clinical performance with significant improvements in clinical hemodynamic performance.
The ADAPT® technology is used to process animal derived tissues to produce implantable tissue prosthetic devices that are compatible with the human body. This technology has been shown to produce reliable, biocompatible and versatile regenerative prosthetic devices capable of being used instead of synthetic products currently used in many soft tissue repair applications.
15 patients with aortic valve insufficiency or stenosis will be enrolled in this single arm single site study.
Follow-up will continue through to 26 weeks.
- Conditions
- Aortic Stenosis, Aortic Insufficiency
- Being tested
- Implantation of ADAPT 3D ALR
- Keywords
- ADAPT, aortic leaflet repair, aortic valve
- Medical subject headings
- Aortic Valve Stenosis, Aortic Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of ADAPT 3D ALRDevice
The operation is performed through a median sternotomy and with the hemodynamic support of standard cardiopulmonary bypass (CBP). diseased leaflets are excised meticulously. Calcifications at the level of the annulus will be removed just like in any other aortic valve replacement procedure. The annulus will be sized and the appropriate 3D single piece valve will be chosen. The implant technique will consist out of one running suture line at the level of the annulus, followed by fixation of the 3 commissural parts against the aortic wall. Valve competence and function will be assessed visually, and by TEE immediately coming of bypass.
| Study group | Role | What they receive |
|---|---|---|
| ADAPT 3D ALR | Experimental | Patients treated with ADAPT 3D ALR Receives: Device: Implantation of ADAPT 3D ALR |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean pressure gradient (mmHg) across the valve (less than 20 mmHg)
Hemodynamic Performance Assessment
Measured: 6 months following implantation
derived Effective Orifice Area (EOA) range > 0.9 cm2 (19mm valve) to > 1.6 cm2 (27mm valve)
Hemodynamic Performance Assessment
Measured: 6 months following implantation
rate of thromboembolism
The adverse events consistent with the Objective Performance Criteria (OPC), for flexible heart valves will be compared to those rates defined as acceptable levels in the standard.
Measured: 6 months following implantation
rate of valve thrombosis
The adverse events consistent with the Objective Performance Criteria (OPC), for flexible heart valves will be compared to those rates defined as acceptable levels in the standard.
Measured: 6 months following implantation
rate of major paravalvular leak
The adverse events consistent with the Objective Performance Criteria (OPC), for flexible heart valves will be compared to those rates defined as acceptable levels in the standard.
Measured: 6 months following implantation
rate of major hemorrhage
The adverse events consistent with the Objective Performance Criteria (OPC), for flexible heart valves will be compared to those rates defined as acceptable levels in the standard.
Measured: 6 months following implantation
rate of endocarditis
The adverse events consistent with the Objective Performance Criteria (OPC), for flexible heart valves will be compared to those rates defined as acceptable levels in the standard.
Measured: 6 months following implantation
Secondary outcomes (14)
Rate of Atrial Fibrillation 6 months post procedure
New/post-operative atrial fibrillation - confirmed on ECG after closure till 6 months
Measured: 6 months post procedure
number of days in ICU
Length of stay in the ICU post valve implantation defined as arrival time/date in hours and minutes to transfer to ward time/date in hours and minutes.
Measured: 30 days post procedure
NYHA (New York Heart Association) class Improvement Assessment
Clinically significant improvement (one grade) in the New York Heart Association (NYHA) functional classification. 4 classes of disease: min value Class IV (cardiac disease resulting in inability to carry on any physical activity without discomfort); max value Class I (cardiac disease but without resulting limitations of physical activity)
Measured: 6 months post procedure
number of days in hospital post procedure
Post procedure length of stay defined as the date and time in hours and minutes documented for arrival in the recovery unit to date and time in hours and minutes of discharge in hours and minutes.
Measured: 30 days post procedure
hemoglobin assessment
Hemolysis screen measured by blood test
Measured: 6 months post procedure
Alanine transaminase (ALT)
Hemolysis screen measured by blood test of liver enzyme
Measured: 6 months post procedure
Aspartate transaminase (AST)
Hemolysis screen measured by blood test of liver enzyme
Measured: 6 months post procedure
Rate of all-caused death
The rate will be compared to clinical outcomes for surgically implanted heart valves reported in the literature.
Measured: 6 months following implantation
Rate of valve related death
The rate will be compared to clinical outcomes for surgically implanted heart valves reported in the literature.
Measured: 6 months following implantation
Rate of valve-related reoperation
The rate will be compared to clinical outcomes for surgically implanted heart valves reported in the literature.
Measured: 6 months following implantation
Rate of valve explant
The rate will be compared to clinical outcomes for surgically implanted heart valves reported in the literature.
Measured: 6 months following implantation
Rate of hemorrhage
The rate will be compared to clinical outcomes for surgically implanted heart valves reported in the literature.
Measured: 6 months following implantation
Rate of all-cause reoperation
The rate will be compared to clinical outcomes for surgically implanted heart valves reported in the literature.
Measured: 6 months following implantation
Rate of Device deficiency
Device deficiency measured by echo
Measured: 6 months following implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start26 Mar 2020
- Primary completionJun 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic StenosisStudies 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
- Model description
- prospective, non-randomised, single arm, single-centre First In Human clinical investigation
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anteris Technologies Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Factory CRO for Medical Devices B.V.
- Responsible party
- Sponsor
- Investigators
- Bart Meuris, Prof. Dr., Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04178213
- Sponsor's protocol ID
- GLRA-G012
- Status last verified
- Feb 2022
- First submitted
- 19 Nov 2019
- Last updated
- 16 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First in Human Surgical Implantation of Single Piece ADAPT® Treated 3D ALR (Aortic Leaflet Repair), Feasibility and Clinical Safety Study
- ClinicalTrials.gov ID
- NCT04178213
- Acronym / sponsor ID
- GLRA-G012
- Conditions
- Aortic Stenosis, Aortic Insufficiency
- Keywords
- ADAPT, aortic leaflet repair, aortic valve
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Anteris Technologies Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Factory CRO for Medical Devices B.V.
- Study start
- 26 Mar 2020 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 26 Nov 2019 (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 study will evaluate the safety and performance of the ADAPT 3D - ALR in adult patients requiring replacement of aortic valve. 15 patients in one site in Belgium will all be treated with ADAPT 3D - ALR.
Detailed description
The purpose of this study is to conduct the initial clinical investigation of single piece ADAPT treated 3D - ALR (Aortic Leaflet Repair) to collect evidence on the device's safety and performance. The study is anticipated to confirm successful clinical safety and clinical performance with significant improvements in clinical hemodynamic performance.
The ADAPT® technology is used to process animal derived tissues to produce implantable tissue prosthetic devices that are compatible with the human body. This technology has been shown to produce reliable, biocompatible and versatile regenerative prosthetic devices capable of being used instead of synthetic products currently used in many soft tissue repair applications.
15 patients with aortic valve insufficiency or stenosis will be enrolled in this single arm single site study.
Follow-up will continue through to 26 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- prospective, non-randomised, single arm, single-centre First In Human clinical investigation
| Arm | Type | Receives |
|---|---|---|
| ADAPT 3D ALR | Experimental | Device: Implantation of ADAPT 3D ALRPatients treated with ADAPT 3D ALR |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient is older than 18 years of age and ≤ 85 years.
- The subject's aortic annular measurements are ≥ 21 mm to < 27mm as confirmed on pre-op echo.
- The subject is a candidate for Aortic Valve Replacement.
- The subject has documented moderate or severe Aortic Stenosis and/or Aortic Insufficiency (defined as grade 2, 3 or 4).
- The subject is willing and able to comply with specified follow-up requirements and evaluations, including transesophageal echocardiography (TEE) if there are inadequate images by transthoracic echocardiography (TTE) to assess the aortic valve.
Key exclusion criteria (18 listed)
- All patients who require emergency surgery (within 24 hours of a presentation to an emergency department) for any reason.
- Subject with a pre-existing valve prosthesis in the aortic position.
- Patients requiring repair of other cardiac valves will be excluded.
- Subject with active endocarditis.
- Heavily calcified aortic roots or "porcelain aortas".
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 |
|---|---|---|
| Implantation of ADAPT 3D ALRThe operation is performed through a median sternotomy and with the hemodynamic support of standard cardiopulmonary bypass (CBP). diseased leaflets are excised meticulously. Calcifications at the level of the annulus will be removed just like in any other aortic valve replacement procedure. The annulus will be sized and the appropriate 3D single piece valve will be chosen. The implant technique will consist out of one running suture line at the level of the annulus, followed by fixation of the 3 commissural parts against the aortic wall. Valve competence and function will be assessed visually, and by TEE immediately coming of bypass. | Device | ADAPT 3D ALR |
Primary outcome
mean pressure gradient (mmHg) across the valve (less than 20 mmHg)
Time frame: 6 months following implantation
Hemodynamic Performance Assessment
derived Effective Orifice Area (EOA) range > 0.9 cm2 (19mm valve) to > 1.6 cm2 (27mm valve)
Time frame: 6 months following implantation
Hemodynamic Performance Assessment
rate of thromboembolism
Time frame: 6 months following implantation
The adverse events consistent with the Objective Performance Criteria (OPC), for flexible heart valves will be compared to those rates defined as acceptable levels in the standard.
rate of valve thrombosis
Time frame: 6 months following implantation
The adverse events consistent with the Objective Performance Criteria (OPC), for flexible heart valves will be compared to those rates defined as acceptable levels in the standard.
rate of major paravalvular leak
Time frame: 6 months following implantation
The adverse events consistent with the Objective Performance Criteria (OPC), for flexible heart valves will be compared to those rates defined as acceptable levels in the standard.
rate of major hemorrhage
Time frame: 6 months following implantation
The adverse events consistent with the Objective Performance Criteria (OPC), for flexible heart valves will be compared to those rates defined as acceptable levels in the standard.
rate of endocarditis
Time frame: 6 months following implantation
The adverse events consistent with the Objective Performance Criteria (OPC), for flexible heart valves will be compared to those rates defined as acceptable levels in the standard.
14 secondary outcomes
Rate of Atrial Fibrillation 6 months post procedure
Time frame: 6 months post procedure
number of days in ICU
Time frame: 30 days post procedure
NYHA (New York Heart Association) class Improvement Assessment
Time frame: 6 months post procedure
number of days in hospital post procedure
Time frame: 30 days post procedure
hemoglobin assessment
Time frame: 6 months post procedure
Alanine transaminase (ALT)
Time frame: 6 months post procedure
Aspartate transaminase (AST)
Time frame: 6 months post procedure
Rate of all-caused death
Time frame: 6 months following implantation
Rate of valve related death
Time frame: 6 months following implantation
Rate of valve-related reoperation
Time frame: 6 months following implantation
Rate of valve explant
Time frame: 6 months following implantation
Rate of hemorrhage
Time frame: 6 months following implantation
Rate of all-cause reoperation
Time frame: 6 months following implantation
Rate of Device deficiency
Time frame: 6 months following implantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2022.
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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.
Bart Meuris, Prof. Dr. principal investigator
Universitaire Ziekenhuizen KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantation of ADAPT 3D ALR in people with Aortic Stenosis and Aortic Insufficiency, run by Anteris Technologies Ltd. at 1 site in Belgium.
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 18 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 16 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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 Factory CRO (+31 30 229 2727, jurriaan.sombeek@avaniaclinical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mean pressure gradient (mmHg) across the valve (less than 20 mmHg) (time frame: 6 months following implantation). The study lists 7 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 16 Feb 2022.