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

NCT04178213 | Unknown DMC

• 1 other identifier: GLRA-G012
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Aortic Stenosis; Aortic Insufficiency

Keywords

ADAPT; aortic leaflet repair; aortic valve

Outcome Measures

Primary Outcomes (7)

• mean pressure gradient (mmHg) across the valve (less than 20 mmHg)

  Hemodynamic Performance Assessment

  6 months following implantation

• derived Effective Orifice Area (EOA) range > 0.9 cm2 (19mm valve) to > 1.6 cm2 (27mm valve)

  Hemodynamic Performance Assessment

  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.

  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.

  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.

  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.

  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.

  6 months following implantation

Secondary Outcomes (14)

• Rate of Atrial Fibrillation 6 months post procedure

  6 months post procedure

• number of days in ICU

  30 days post procedure

• NYHA (New York Heart Association) class Improvement Assessment

  6 months post procedure

• number of days in hospital post procedure

  30 days post procedure

• hemoglobin assessment

  6 months post procedure

Study Arms (1)

ADAPT 3D ALR

EXPERIMENTAL

Patients treated with ADAPT 3D ALR

Device: Implantation of ADAPT 3D ALR

Interventions

Implantation of ADAPT 3D ALR 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.

ADAPT 3D ALR

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Anteris Technologies Ltd.: lead
• Factory CRO for Medical Devices B.V.: collaborator

Study Sites (1)

University Hospital Leuven

Leuven, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis; Aortic Valve Insufficiency

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Bart Meuris, Prof. Dr.

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Factory CRO

CONTACT

+31 30 229 2727; jurriaan.sombeek@avaniaclinical.com

Deanna Linden

CONTACT

+1 651 493 0606; dlinden@anteristech.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: November 19, 2019
• First Posted: November 26, 2019
• Study Start: March 26, 2020
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: February 16, 2022

Record last verified: 2022-02

Locations

BE (1)