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

March 12, 2013
March 12, 2013
August 2012
August 2013   (final data collection date for primary outcome measure)
Mortality [ Time Frame: Early (within 30 days after surgery), Late (After 12 months) ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
Mitral Valve prolapse measurement after using neochordae [ Time Frame: Intra-operation, 3, 6, and 12 months after surgery ] [ Designated as safety issue: No ]
Same as current
Cardiopulmonary bypass time [ Time Frame: During Surgery ] [ Designated as safety issue: Yes ]
Same as current
 
Safety and Efficacy Study of a New Device for Making Neochordae in Mitral Valve Repair
Phase II Study of Using a New Device (Neochordameter) in Making Artificial Chordae for Mitral Valve Repair

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.

Not Provided
Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Mitral Valve Repair
Device: Artificial Chordae
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.
Intervention: Device: Artificial Chordae
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
20
August 2014
August 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Nothing
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01811537
91-01-149-17122-59685
Yes
Alireza Ghavidel, Tehran University of Medical Sciences
Tehran University of Medical Sciences
Not Provided
Not Provided
Tehran University of Medical Sciences
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP