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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Alireza Ghavidel, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01811537
First received: March 12, 2013
Last updated: NA
Last verified: March 2013
History: No changes posted
  Purpose

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 Intervention Phase
Mitral Valve Repair
Device: Artificial Chordae
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase II Study of Using a New Device (Neochordameter) in Making Artificial Chordae for Mitral Valve Repair

Resource links provided by NLM:


Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • Mortality [ Time Frame: Early (within 30 days after surgery), Late (After 12 months) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Mitral Valve prolapse measurement after using neochordae [ Time Frame: Intra-operation, 3, 6, and 12 months after surgery ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Cardiopulmonary bypass time [ Time Frame: During Surgery ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: August 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Nothing
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Alireza Ghavidel, Associat Professor of Cardiac Surgery, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01811537     History of Changes
Other Study ID Numbers: 91-01-149-17122-59685
Study First Received: March 12, 2013
Last Updated: March 12, 2013
Health Authority: Iran: Ethics Committee

Keywords provided by Tehran University of Medical Sciences:
Artificial Chordae
Mitral Valve Repair

ClinicalTrials.gov processed this record on September 18, 2014