Functional Tricuspid Regurgitation Clinical Trial
Official title:
Outcome of MC3 Ring Annuloplasty for Moderate and Severe Functional Tricuspid Regurgitation Associated With Rheumatic Mitral Valve Disease
NCT number | NCT04078867 |
Other study ID # | 62-15 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2016 |
Est. completion date | December 31, 2018 |
Verified date | September 2019 |
Source | Minia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
This study includes 105 patients who underwent repair for ≥ moderate tricuspid regurgitation (TR) during mitral valve replacement for rheumatic valve disease. Between January 2016 and December 2018, a group of 23 patients underwent ring annuloplasty with Edward MC3 rings were compared to another group of 82 patients underwent standard suture (DeVega) repair. The primary outcome was residual TR (≥ moderate TR).
Status | Completed |
Enrollment | 105 |
Est. completion date | December 31, 2018 |
Est. primary completion date | December 31, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Rheumatic mitral valve disease - Surgery for mitral valve replacement - Severe functional tricuspid regurgitation - Moderate functional tricuspid regurgitation with annular dilatation > 40 mm - Moderate functional tricuspid regurgitation with preoperative systolic pulmonary artery pressure (SPAP) >50 mmHg Exclusion Criteria: - Patients with non-rheumatic mitral disease - Combined mitral and aortic valve replacement - Mitral valve repair - Concomitant coronary artery or aortic surgery - Mild or organic tricuspid regurgitation - Emergency surgery - Reoperations - Invalid or missed data |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Minia University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Residual tricuspid regirgitation (TR) | residual TR is defined when there is moderate or above degree of TR at the last follow-up echocardiography of the patient | 3-33 months |
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