A Study of the CardiAQ-Edwards ™ Transcatheter Mitral Valve (TMV) System for patients requiring mitral valve replacement

Not Applicable

Withdrawn

• Conditions: Mitral Regurgitation; Cardiovascular - Other cardiovascular diseases; Surgery - Surgical techniques

• Registration Number: ACTRN12618000103268
• Lead Sponsor: Edwards Lifesciences, LLT

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-01-23
• Last Update Posted: 10 February 2020

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

•Clinically significant, symptomatic mitral regurgitation
•High risk for open-heart surgery
•Meets anatomical criteria

Exclusion Criteria

•Unsuitable anatomy
•Patient is inoperable

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety assessed by freedom from device or procedure-related adverse events:<br>Freedom from death at 30 days from the implant procedure<br>[30 days from the implant procedure];Safety assessed by freedom from device or procedure-related adverse events:<br>Freedom from Major Adverse Cardiac and Cerebrovascular Events (MACCE; defined as death, MI, stroke and renal failure), severe bleeding and re-intervention at 30 days, from the implant procedure[30 days from the implant procedure]

Secondary Outcome Measures

Name	Time	Method
YHA functional class: Number of patients with improvement in NYHA class from baseline in symptoms<br>Functional class will be evaluated during follow-ups using New York Heart Association Functional Classification. <br>[30 days, 3 months, 6 months, 12 months and annually for five years, from baseline in symptoms. ];American Thoracic Surgery Six Minute Walk Test: Increase in distance (m) from baseline performance<br>[30 days, 3 Months ,6 Months, 12 Months, annual for five years, compared to baseline performance];Reduction in MR grade: Number of patients with reduction in mitral regurgitation grade from baseline assessed via Transesophageal Echocardiography <br>[30 days, 3 Months ,6 Months, 12 Months, annual for five years, compared to baseline<br>]