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

NCT01811537 | Unknown Phase 1 DMC

• 1 other identifier: 91-01-149-17122-59685
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Mitral Valve Repair

Keywords

Artificial Chordae; Mitral Valve Repair

Outcome Measures

Primary Outcomes (1)

• Mortality

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

Secondary Outcomes (1)

• Mitral Valve prolapse measurement after using neochordae

  Intra-operation, 3, 6, and 12 months after surgery

Other Outcomes (1)

• Cardiopulmonary bypass time

  During Surgery

Study Arms (1)

Experimental: premeasured Neochordae

EXPERIMENTAL

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

Interventions

Artificial Chordae DEVICE

Experimental: premeasured Neochordae

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Nothing

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associat Professor of Cardiac Surgery

Study Record Dates

• First Submitted: March 12, 2013
• First Posted: March 14, 2013
• Study Start: August 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2014
• Last Updated: March 14, 2013

Record last verified: 2013-03