Safety and Efficacy Study of a New Device for Making Neochordae in Mitral Valve Repair

Phase 1

• Conditions: Mitral Valve Repair
• Interventions: Device: Artificial Chordae

• Registration Number: NCT01811537
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

Mitral prolapse is a common cardiac disease whose patients are at higher risk for serious complications. Mitral valve (MV) repair offers several important advantages compared with valve replacement and it achieves excellent midterm and long-term results. Two major problems of using pre-measured expanded polytetrafluoroethylene(ePTFE) neochordae (the loop technique) are deciding the length of the neochordae and tying the knot at the intended length. Therefore, a great need still exists to find new method to simplify and precise the length of neochordae. 20 patients with mitral valve prolapse who undergo mitral valve repair using neochorda will be recruited in this study. Trans thoracic echocardiography (TTE) will be done preoperatively for all patients. Two, three, and four chamber view of each patient will be pre-operatively recorded. The device will be set with extracted measurements. Artificial corda loops are made using CV-4 ePTFE sutures. After artificial chordae replacement, the ring annuloplasty will be done. Follow up: A leakage test after attaching the 1st loop; Post operative trans esophageal echocardiography (TEE) and determining the severity of mitral regurgitation \[Wall motion Score Index (WMSI), Mitral Annulus Area (MAA), LVEF, End Systolic Volume (ESV), End Diastolic Volume (EDV), Iso-Volemic Relaxation Time (IVRT), (IVRT/(QE-QE\^') ,Chamber Relaxation velocity)/(Myocard relaxation velocity(E/E\^' ), HR\]; TEE 3 months after discharge; Cross clamp time; Intubation period in ICU.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Status Verified: 2013-03
• Study First Submitted: 2013-03-12
• Study First Submitted QC: 2013-03-12
• Last Update Submitted: 2013-03-12
• Study First Posted: 2013-03-14
• Last Update Posted: 2013-03-14
• Primary Completion: 2013-08
• Study Completion: 2014-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patients with Mitral valve prolapse who undergo mitral valve repair using neochorda

Exclusion Criteria

• Nothing

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental: premeasured Neochordae	Artificial Chordae	Transthoracic echocardiography(TTE) is done for all patients. The new device will be setup using the TTE measurements.The artificial Chordae loops will be made at the operation room before starting the surgery. These loops will be attached to the respective papillary muscle's head and the free edge of respective prolapsed scallop.

Primary Outcome Measures

Name	Time	Method
Mortality	Early (within 30 days after surgery), Late (After 12 months)

Secondary Outcome Measures

Name	Time	Method
Mitral Valve prolapse measurement after using neochordae	Intra-operation, 3, 6, and 12 months after surgery