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

Mitral Valve Repair Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01811537
• Other study ID #: 91-01-149-17122-59685
• Status: Enrolling by invitation
• Phase: Phase 1/Phase 2
• First received: March 12, 2013
• Last updated: March 12, 2013
• Start date: August 2012
• Est. completion date: August 2014

Study information

• Verified date: March 2013
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: August 2014
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Nothing

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mitral Valve Repair

Intervention

Device:
• Artificial Chordae

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cardiopulmonary bypass time		During Surgery	Yes
Primary	Mortality		Early (within 30 days after surgery), Late (After 12 months)	Yes
Secondary	Mitral Valve prolapse measurement after using neochordae		Intra-operation, 3, 6, and 12 months after surgery	No