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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

Status
UNKNOWN
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01811537
Enrollment
20
Registered
2013-03-14
Start date
2012-08-31
Completion date
2014-08-31
Last updated
2013-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mitral Valve Repair

Keywords

Artificial Chordae, Mitral Valve Repair

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.

Interventions

DEVICEArtificial Chordae

Sponsors

Tehran University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Nothing

Design outcomes

Primary

MeasureTime frame
MortalityEarly (within 30 days after surgery), Late (After 12 months)

Secondary

MeasureTime frame
Mitral Valve prolapse measurement after using neochordaeIntra-operation, 3, 6, and 12 months after surgery

Other

MeasureTime frame
Cardiopulmonary bypass timeDuring Surgery

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026