First in Human Feasibility Study With ADAPT 3D - ALR for Aortic Leaflet Repair

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-26

Study Completion Date

2022-06-30

Brief Summary

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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.

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Detailed Description

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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

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Aortic Stenosis Aortic Insufficiency

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

prospective, non-randomised, single arm, single-centre First In Human clinical investigation

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ADAPT 3D ALR

Patients treated with ADAPT 3D ALR

Group Type EXPERIMENTAL

Implantation of ADAPT 3D ALR

Intervention Type DEVICE

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.

Interventions

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Implantation of 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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Patient is older than 18 years of age and ≤ 85 years.
2. The subject's aortic annular measurements are ≥ 21 mm to \< 27mm as confirmed on pre-op echo.
3. The subject is a candidate for Aortic Valve Replacement.
4. The subject has documented moderate or severe Aortic Stenosis and/or Aortic Insufficiency (defined as grade 2, 3 or 4).
5. 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.
6. Patient has signed the informed consent

Exclusion Criteria

1. All patients who require emergency surgery (within 24 hours of a presentation to an emergency department) for any reason.
2. Subject with a pre-existing valve prosthesis in the aortic position.
3. Patients requiring repair of other cardiac valves will be excluded.
4. Subject with active endocarditis.
5. Heavily calcified aortic roots or "porcelain aortas".
6. Leukopenia with a WBC (white Blood Cells) of less than 3000.
7. Acute anaemia with a haemoglobin less than 8 g/dL.
8. 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).
9. History of a defined bleeding diathesis or coagulopathy or the subject refuses blood transfusions.
10. Active infection requiring antibiotic therapy (if temporary illness, subjects may enroll 2-4 weeks after discontinuation of antibiotics).
11. Subjects in whom transesophageal echocardiography (TEE) is contraindicated.
12. Low EF \< 50 %.
13. Life expectancy \< 1 year, or severe comorbidities, such as cancer, dialysis, or severe COPD.
14. The subject is an illicit drug user, alcohol abuser, prisoner, institutionalised, or is unable to give informed consent.
15. The subject is pregnant or lactating (non-pregnancy to be confirmed by pregnancy test for all child bearing potential females).
16. Recent (within 6 months) cerebrovascular accident (CVA) or a transient ischemic attack (TIA).
17. Myocardial Infarction (MI) within one month of trial inclusion.
18. 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No