Engager Align Post-market Clinical Study

Brief Title

Engager Align Post-market Clinical Study

Official Title

The Engager ALIGN Study. To Characterize the Safety and Clinical Benefit of the Engager Transcatheter Aortic Valve Implantation System in a Real World Environment.

Brief Summary

      Purpose To characterize the safety and clinical benefit of the Engager Transcatheter Aortic
      Valve Implantation System in a real world environment.

      Design Prospective non-randomized, non-interventional, multicenter, single-arm, post-market
      study.

      250 Patients will have the Engager bioprosthesis implanted. Patients will be followed at 1
      month, 6 months, and 12 months after the procedure. The recruitment period will be
      approximately 12 months, so the total study duration will be 24 months.

Detailed Description

      The study objective is to characterize the safety and clinical benefit of the Engager
      Transcatheter Aortic Valve Implantation System in a real world setting.

      The primary endpoint of this study is all-cause mortality at 30 days or during index
      hospitalization.

      Secondary endpoints of this study are:

        -  Device success according to VARC2 is defined as:

        -  absence of procedural mortality (all-cause mortality at discharge, 30 days or during
           index hospitalization), AND

        -  correct positioning of the Engager bioprosthesis in the proper anatomic location, AND

        -  Engager bioprosthesis performing as intended (no prosthesis-patient mismatch and mean
           aortic valve gradient < 20 mmHg or peak velocity < 3 m/s, AND no moderate or severe
           regurgitation).

        -  Composite early safety (at 30 days) according to VARC2 includes the following
           components:

        -  all-cause mortality

        -  all stroke

        -  life-threatening bleeding

        -  acute kidney injury (stage 2-3)

        -  coronary artery obstruction requiring intervention

        -  major vascular complication

        -  valve-related dysfunction requiring repeat procedure (BAV, TAVI or SAVR)

        -  Clinical efficacy according to VARC2 at 6 months and 1 year is defined as:

        -  all-cause mortality

        -  all stroke

        -  hospitalizations for valve-related symptoms or worsening congestive heart failure (CHF)

        -  NYHA class III or IV

        -  valve-related dysfunction (mean aortic valve gradient ≥20 mm Hg, effective orifice area
           (EOA) ≤0.9-1.1 cm² and/or Doppler velocity index (DVI) <0.35 m/s, AND/OR moderate or
           severe prosthetic valve regurgitation)

        -  Time-related valve safety accordingly to VARC2 at 6 months and 1 year is defined as:

        -  Structural valve deterioration

        -  Valve-related dysfunction (mean aortic valve gradient ≥20 mm Hg, (EOA) ≤0.9-1.1 cm²
           and/or (DVI) <0.35 m/s, AND/OR moderate or severe prosthetic valve regurgitation)

        -  Requiring repeat procedure (TAVI or SAVR)

        -  Prosthetic valve endocarditis

        -  Prosthetic valve thrombosis

        -  Thrombo-embolic events (e.g. stroke)

        -  VARC bleeding, unless clearly unrelated to valve therapy (e.g. trauma)

             -  All-cause mortality at 6 months and 1 year

             -  Cardiovascular mortality at 30 days, 6 months and 1 year

             -  Incidence of TAVI-related complications at 30 days, 6 months and 1 year:

        -  Myocardial infarction

        -  Periprocedural and spontaneous stroke

        -  Life-threatening, major and minor bleedings

        -  Acute kidney injury state 1, 2 and 3

        -  Apical and vascular complications

        -  Conduction disturbances

        -  Conversion to open-heart surgery

        -  Unplanned use of cardiopulmonary bypass

        -  Coronary obstruction and dissection

        -  Ventricular septal perforation

        -  Mitral valve apparatus damage or dysfunction

        -  Cardiac tamponade

        -  Endocarditis

        -  Valve thrombus

        -  Valve migration, embolization or ectopic valve deployment

        -  Valve in valve deployment

             -  Total, transvalvular and paravalvular regurgitation as measured by TTE at 30 days
                and 1 year

             -  Mean aortic valve gradient, peak velocity and effective orifice area as measured by
                TTE at 30 days and 1 year

             -  Engager implant depth as measured by standard of care angiography at the end of
                implant procedure

             -  Incidence and rationale for permanent pacemaker implantation after Engager implant
                procedure

             -  Changes in Quality of Life as measured by the EQ5D questionnaire at baseline,
                discharge, 30 days, 6 months and 1 year

             -  Length of stay during index hospitalization (ICU and general ward)

             -  Incidence of re-hospitalization at 30 days, 6 months and 1 year

      Subject population All patients with severe aortic stenosis requiring treatment, who are
      selected by a heart team to be treated electively with the Engager Transcatheter Aortic Valve
      Implantation System are eligible to be included in this study.

      Treatment The Engager Transcatheter Aortic Bioprosthesis will be implanted using the Engager
      Transcatheter Delivery System. The bioprosthesis is delivered transapically on a catheter
      during a beating heart procedure.

Study Type

Observational [Patient Registry]

Primary Outcome

is to characterize the safety and clinical benefit of the Engager Transcatheter Aortic Valve Implantation System in a real world setting.

Secondary Outcome

 Device success according to VARC2

Condition

Aortic Valve Stenosis

Intervention

Engager Transcatheter Aortic Valve Implantation System

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Device

Estimated Enrollment

Start Date

May 2014

Completion Date

January 2017

Primary Completion Date

August 2016

Eligibility Criteria

        Inclusion Criteria:

        Patient can be included if ALL of the following criteria are met:

          -  Patient with severe aortic valve stenosis requiring treatment;

          -  Patient is an acceptable candidate for elective treatment with the Medtronic Engager
             Transcatheter Aortic Valve Implantation System and in conformity with the local
             regulatory requirements;

          -  Patient is above the minimum age as required by local regulations to be participating
             in a clinical study;

          -  The patient has been informed of the nature of the study and has consented to
             participate, and has authorized the collection and release of his/her medical
             information by signing a consent form (Patient Informed Consent Form or Data Release
             Form).

        Exclusion Criteria:

        Patient will not be included if any of the following conditions exist:

          -  Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine,
             clopidogrel, Nitinol of contrast medium that cannot be adequately controlled with
             pre-medication;

          -  Intracardiac mass, thrombus, or vegetation;

          -  Aortic aneurysm;

          -  Sepsis or acute endocarditis;

          -  Bleeding diathesis, or coagulopathy;

          -  Cardiogenic shock, suspected cardiogenic shock;

          -  Unicuspid or bicuspid aortic valve;

          -  Pre-existing prosthetic heart valve in aortic position;

          -  Patient is currently enrolled in another investigational device or drug trial;

          -  Patients with life expectancy less than 12 months after TAVI.

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Hendrik Treede, MD, ,

Location Countries

Netherlands

Location Countries

Netherlands

Administrative Informations

NCT ID

NCT02149654

Organization ID

RAE00937

Responsible Party

Sponsor

Study Sponsor

Medtronic Bakken Research Center

Study Sponsor

Hendrik Treede, MD, Principal Investigator, Universitätsklinikum Hamburg

Verification Date

April 2018