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Engager Align Post-market Clinical Study

NCT02149654 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 27

Last updated 2018-04-27

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Medtronic Cardiac Rhythm and Heart Failure

    lead INDUSTRY

Principal Investigators

  • Hendrik Treede, MD · Universitätsklinikum Hamburg

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2016-08-31
Completion
2017-01-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02149654 on ClinicalTrials.gov