- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04178213
First in Human Feasibility Study With ADAPT 3D - ALR for Aortic Leaflet Repair
First in Human Surgical Implantation of Single Piece ADAPT® Treated 3D ALR (Aortic Leaflet Repair), Feasibility and Clinical Safety Study
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Factory CRO
- Phone Number: +31 30 229 2727
- Email: jurriaan.sombeek@avaniaclinical.com
Study Contact Backup
- Name: Deanna Linden
- Phone Number: 1012 +1 651 493 0606
- Email: dlinden@anteristech.com
Study Locations
-
-
-
Leuven, Belgium, 3000
- Recruiting
- University Hospital Leuven
-
Contact:
- Klaartjie Van den Bossche
- Phone Number: +32 16 34 21 60
- Email: klaartje.vandenbossche@uzleuven.be
-
Sub-Investigator:
- Peter Verbrugghe
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ADAPT 3D ALR
Patients treated with ADAPT 3D ALR
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
mean pressure gradient (mmHg) across the valve (less than 20 mmHg)
Time Frame: 6 months following implantation
|
Hemodynamic Performance Assessment
|
6 months following implantation
|
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
|
6 months following implantation
|
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.
|
6 months following implantation
|
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.
|
6 months following implantation
|
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.
|
6 months following implantation
|
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.
|
6 months following implantation
|
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.
|
6 months following implantation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of Atrial Fibrillation 6 months post procedure
Time Frame: 6 months post procedure
|
New/post-operative atrial fibrillation - confirmed on ECG after closure till 6 months
|
6 months post procedure
|
number of days in ICU
Time Frame: 30 days post procedure
|
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.
|
30 days post procedure
|
NYHA (New York Heart Association) class Improvement Assessment
Time Frame: 6 months post procedure
|
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)
|
6 months post procedure
|
number of days in hospital post procedure
Time Frame: 30 days 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.
|
30 days post procedure
|
hemoglobin assessment
Time Frame: 6 months post procedure
|
Hemolysis screen measured by blood test
|
6 months post procedure
|
Alanine transaminase (ALT)
Time Frame: 6 months post procedure
|
Hemolysis screen measured by blood test of liver enzyme
|
6 months post procedure
|
Aspartate transaminase (AST)
Time Frame: 6 months post procedure
|
Hemolysis screen measured by blood test of liver enzyme
|
6 months post procedure
|
Rate of all-caused death
Time Frame: 6 months following implantation
|
The rate will be compared to clinical outcomes for surgically implanted heart valves reported in the literature.
|
6 months following implantation
|
Rate of valve related death
Time Frame: 6 months following implantation
|
The rate will be compared to clinical outcomes for surgically implanted heart valves reported in the literature.
|
6 months following implantation
|
Rate of valve-related reoperation
Time Frame: 6 months following implantation
|
The rate will be compared to clinical outcomes for surgically implanted heart valves reported in the literature.
|
6 months following implantation
|
Rate of valve explant
Time Frame: 6 months following implantation
|
The rate will be compared to clinical outcomes for surgically implanted heart valves reported in the literature.
|
6 months following implantation
|
Rate of hemorrhage
Time Frame: 6 months following implantation
|
The rate will be compared to clinical outcomes for surgically implanted heart valves reported in the literature.
|
6 months following implantation
|
Rate of all-cause reoperation
Time Frame: 6 months following implantation
|
The rate will be compared to clinical outcomes for surgically implanted heart valves reported in the literature.
|
6 months following implantation
|
Rate of Device deficiency
Time Frame: 6 months following implantation
|
Device deficiency measured by echo
|
6 months following implantation
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Bart Meuris, Prof. Dr., Universitaire Ziekenhuizen KU Leuven
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GLRA-G012
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Aortic Stenosis
-
Hospices Civils de LyonRecruiting
-
Abbott Medical DevicesActive, not recruitingSevere Aortic Stenosis | Symptomatic Degenerative Aortic StenosisSpain, Italy, United Kingdom, Germany, Switzerland, Czechia, Australia, Belgium, Poland
-
Edwards LifesciencesActive, not recruitingAortic Stenosis | Aortic Regurgitation | Symptomatic Aortic StenosisChina
-
Anteris Technologies Ltd.Active, not recruitingAortic Valve Calcification | Severe Aortic Valve Stenosis | Symptomatic Aortic StenosisGeorgia
-
Anteris Technologies Ltd.Active, not recruitingAortic Stenosis | Aortic Valve Calcification | Severe Aortic Valve Stenosis | Symptomatic Aortic StenosisUnited States
-
Edwards LifesciencesCompletedAortic Stenosis | Aortic Regurgitation | Symptomatic Aortic StenosisChina
-
Ningbo Jenscare Biotechnology Co., Ltd.UnknownAortic Regurgitation | Severe Aortic Stenosis
-
Genesis Medtech CorporationRecruitingDiseases of Aortic Valve | Aortic Stenosis DiseaseChina
-
Saint Petersburg State University, RussiaNot yet recruitingIschemic Heart Disease | Mitral Insufficiency | Aortic Stenosis, Severe | Mitral Stenosis | Aortic Insufficiency | Ascending Aortic Aneurysm | Mitral Stenosis With Insufficiency | Tricuspid InsufficiencyRussian Federation
-
Pan XiangbinRecruiting
Clinical Trials on Implantation of ADAPT 3D ALR
-
Hôpital du ValaisUnknownInterest of Navigation for the Treatment of Pertrochanteric Fractures With the Gamma 3 Nail (INOPEG)Femoral Fractures | Trochanteric Fractures | Fracture Fixation, InternalSwitzerland
-
Sorin Group USA, Inc.CompletedMitral Valve RegurgitationUnited States, Canada
-
Peking University Third HospitalRecruitingNon-small Cell Lung Cancer | BrachytherapyChina
-
Peking University Third HospitalRecruitingSquamous Cell Carcinomas | BrachytherapyChina
-
Peking University Third HospitalBeijing 302 Hospital; Tengzhou Central People's Hospital; Guangxi Ruikang HospitalUnknownRadiotherapy | Pancreatic Cancer Non-resectable | BrachytherapyChina
-
Tetec AGActive, not recruitingTraumatic Articular Cartilage Defects in the Knee JointUnited Kingdom, Hungary, Czechia, Germany, Lithuania, Austria, France, Latvia, Poland, Switzerland
-
Peking University Third HospitalCompleted
-
Mansoura UniversityActive, not recruiting
-
Steward St. Elizabeth's Medical Center of Boston...RecruitingLeft Bundle-Branch Block | Pacemaker DDDUnited States
-
Goethe UniversityUnknownPlatelet Function | Coagulation Disorder, Blood