Engager Align Post-market Clinical Study

NCT02149654 | Completed DMC

• 1 other identifier: RAE00937
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Valve Stenosis

Keywords

Transcatheter aortic valve implantation; Transcatheter aortic valve replacement; Engager transcatheter aortic valve implantation system; Engager bioprosthesis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Device success according to VARC2

  12 Month follow up

Interventions

Engager Transcatheter Aortic Valve Implantation System DEVICE

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (1)

Medtronic Bakken Research Center

Maastricht, 6229 GW, Netherlands

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Hendrik Treede, MD

  Universitätsklinikum Hamburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2014
• First Posted: May 29, 2014
• Study Start: May 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: January 1, 2017
• Last Updated: April 27, 2018

Record last verified: 2018-04

Locations

NL (1)