Engager Align Post-market Clinical Study

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

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.

Study Overview

• Status: Completed
• Conditions: Aortic Valve Stenosis
• Intervention / Treatment: Device: Engager Transcatheter Aortic Valve Implantation System

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
• Enrollment (Actual): 27

Contacts and Locations

Study Locations

• Netherlands
  • Maastricht, Netherlands, 6229 GW
    • Medtronic Bakken Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
is to characterize the safety and clinical benefit of the Engager Transcatheter Aortic Valve Implantation System in a real world setting.	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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device success according to VARC2	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. 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	12 Month follow up

Collaborators and Investigators

• Sponsor: Medtronic Bakken Research Center
• Investigators: Principal Investigator: Hendrik Treede, MD, Universitatsklinikum Hamburg

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2014
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: March 7, 2014
• First Submitted That Met QC Criteria: May 28, 2014
• First Posted (Estimate): May 29, 2014

Study Record Updates

• Last Update Posted (Actual): April 27, 2018
• Last Update Submitted That Met QC Criteria: April 26, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Transcatheter aortic valve implantation; Transcatheter aortic valve replacement; Engager transcatheter aortic valve implantation system; Engager bioprosthesis
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: RAE00937

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED