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

Sponsor

Tehran University of Medical Sciences (Other)

Overall Status

Unknown status

CT.gov ID

NCT01811537

Collaborator

(none)

Enrollment

Arm

Duration (Months)

Study Details

Study Description

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

Study Design

Study Type:

Interventional

Anticipated 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 :

Aug 1, 2012

Anticipated Primary Completion Date :

Aug 1, 2013

Anticipated Study Completion Date :

Aug 1, 2014

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Mitral Valve prolapse measurement after using neochordae [Intra-operation, 3, 6, and 12 months after surgery]

Other Outcome Measures

Cardiopulmonary bypass time [During Surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Nothing

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Tehran University of Medical Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Alireza Ghavidel, Associat Professor of Cardiac Surgery, Tehran University of Medical Sciences

ClinicalTrials.gov Identifier:

NCT01811537

Other Study ID Numbers:

91-01-149-17122-59685

First Posted:

Mar 14, 2013

Last Update Posted:

Mar 14, 2013

Last Verified:

Mar 1, 2013

Keywords provided by Alireza Ghavidel, Associat Professor of Cardiac Surgery, Tehran University of Medical Sciences

Artificial Chordae

Mitral Valve Repair

Study Results

No Results Posted as of Mar 14, 2013