DYANA Study - Dynamic Annuloplasty System with Activation for the Treatment of Mitral Regurgitatio

Completed

• Conditions: Heartvalve leakage; Mitral valve regurgitation; 10046973; 10007593

• Registration Number: NL-OMON33949
• Lead Sponsor: MiCardia Corporation, Jody L. Errandi M.S., Director of Clinical

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

1.This patient requires mitral valve repair with or without concomitant procedures such as coronary artery bypass or another valve reconstruction or replacement.
2.This patient has been diagnosed with a diseased natural valve, based on
echocardiography and is a candidate for mitral valve repair.
3.This patient is in satisfactory condition, based on the physical exam and investigator's experience, to be an average or better operative risk. (i.e., likely to survive one year postoperatively)

Exclusion Criteria

1. This patient is less than eighteen (18) years of age.
2. This patient has a non-cardiac major or progressive disease, which in the investigators experience produces an unacceptable increased risk to the patient, or results in a life expectancy of less than twelve months.
3. Patient who has heavily calcified annulus or leaflets.
4. reoperation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary safety endpoint is the occurrence of; death, endocarditis,<br /><br>ring dehiscence, systolic anterior motion (SAM), embolic event,<br /><br>pulmonary edema, heart block, arrhythmia, hemolysis, and myocardial<br /><br>infarction (MI) at 30 days post-procedure.<br /><br><br /><br>The primary efficacy endpoint is ability to reduce mitral regurgitation to<br /><br>less than 2+ immediately following surgical implantation of the<br /><br>annuloplasty device.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary safety endpoint is the occurrence of; death, endocarditis,<br /><br>ring dehiscence, systolic anterior motion (SAM), embolic event,<br /><br>pulmonary edema, heart block, arrhythmia, hemolysis, and myocardial<br /><br>infarction (MI) at 6 months post-procedure.<br /><br><br /><br>The secondary efficacy endpoint is the ability to further reduce residual<br /><br>regurgitation following annuloplasty ring implantation and /or to enhance<br /><br>coaptation distance using intra-operative activation of the device.</p><br>