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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01811537
Recruitment Status : Unknown
Verified March 2013 by Alireza Ghavidel, Tehran University of Medical Sciences.
Recruitment status was:  Enrolling by invitation
First Posted : March 14, 2013
Last Update Posted : March 14, 2013
Information provided by (Responsible Party):
Alireza Ghavidel, 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.

Condition or disease Intervention/treatment Phase
Mitral Valve Repair Device: Artificial Chordae Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase II Study of Using a New Device (Neochordameter) in Making Artificial Chordae for Mitral Valve Repair
Study Start Date : August 2012
Estimated Primary Completion Date : August 2013
Estimated Study Completion Date : August 2014

Arm Intervention/treatment
Experimental: Experimental: premeasured Neochordae
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.
Device: Artificial Chordae

Primary Outcome Measures :
  1. Mortality [ Time Frame: Early (within 30 days after surgery), Late (After 12 months) ]

Secondary Outcome Measures :
  1. Mitral Valve prolapse measurement after using neochordae [ Time Frame: Intra-operation, 3, 6, and 12 months after surgery ]

Other Outcome Measures:
  1. Cardiopulmonary bypass time [ Time Frame: During Surgery ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Nothing
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Responsible Party: Alireza Ghavidel, Associat Professor of Cardiac Surgery, Tehran University of Medical Sciences Identifier: NCT01811537    
Other Study ID Numbers: 91-01-149-17122-59685
First Posted: March 14, 2013    Key Record Dates
Last Update Posted: March 14, 2013
Last Verified: March 2013
Keywords provided by Alireza Ghavidel, Tehran University of Medical Sciences:
Artificial Chordae
Mitral Valve Repair