Hancock II Ultra Porcine Bioprosthesis Hemodynamic Study

Recruiting

• Conditions: aortic valve disease; 10046973

• Registration Number: NL-OMON38091
• Lead Sponsor: Medtronic B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 45

Inclusion Criteria

- Patients who require aortic valve replacement with or without coronary artery bypass grafting or
surgical treatment of atrial fibrillation or mitral valve repair.
- Patients who are able to provide informed consent.

Exclusion Criteria

- Concomitant procedures other than coronary artery bypass grafting, surgical treatment of atrial
fibrillation or mitral valve repair.
- Patients indicated for receiving a mechanical prosthesis.
- Patients who will have a replacement of existing valve prosthesis.
- Patients refusing or not able to provide informed consent.
- Patients requiring emergency surgery.
- Patients unable to participate in follow-up

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective of the study is the hemodynamic performance of the<br /><br>bioprosthesis at 6 and 12 months after surgery. This will be measured by<br /><br>comparing the mean aortic valve gradients pre-and post-surgery. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary endpoint of the study is the incidence of patient prosthesis<br /><br>mismatch (PPM). During implant, the valve size of the patient's annulus will be<br /><br>measured using universal sizer and Hancock II Ultra sizer, and these<br /><br>measurements will be compare to valve sizes ultimately used for implant. In<br /><br>this way we can find out which valve size is most suitable for a certain native<br /><br>annulus diameter.</p><br>