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Clinical Trials/NCT01811537
NCT01811537
Unknown
Phase 1

Phase II Study of Using a New Device (Neochordameter) in Making Artificial Chordae for Mitral Valve Repair

Tehran University of Medical Sciences0 sites20 target enrollmentAugust 2012

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Mitral Valve Repair
Sponsor
Tehran University of Medical Sciences
Enrollment
20
Primary Endpoint
Mortality
Last Updated
13 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2012
End Date
August 2014
Last Updated
13 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Alireza Ghavidel

Associat Professor of Cardiac Surgery

Tehran University of Medical Sciences

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Mortality

Time Frame: Early (within 30 days after surgery), Late (After 12 months)

Secondary Outcomes

  • Mitral Valve prolapse measurement after using neochordae(Intra-operation, 3, 6, and 12 months after surgery)

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