NCT02149654

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.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 27 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Aortic Valve Stenosis

Interventions

Type	Name	Description
DEVICE	Engager Transcatheter Aortic Valve Implantation System	The Engager Transcatheter Aortic Valve Implantation System is indicated for use in patients with symptomatic severe aortic valve stenosis requiring aortic valve replacement and are at high or extreme risk for operative mortality or comorbidity judged by the heart team to pose an absolute or relative contraindication for conventional aortic valve replacement. The system is intended for use in patients with a life expectancy of at least one year following TAVI. The intended performance of the system is to provide relief of aortic valve obstruction without inducing significant regurgitation, thereby restoring effective hemodynamic function of the diseased aortic valve. The intended purpose of the system in this clinical study is in line with the intended purpose in the Instructions for Use.

Timeline

• Start date: 2014-05-01
• Primary completion: 2016-08-01
• Completion: 2017-01-01
• First posted: 2014-05-29
• Last updated: 2018-04-27

Locations

1 site across 1 country: Netherlands