ACTRN12620000564954
Recruiting
未知
Evaluation of Outcomes Following Tricuspid Valve Cylinder Reconstruction with CardioCel® in Isolated Severe Tricuspid Regurgitation
The Alfred0 sites10 target enrollmentMay 14, 2020
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Tricuspid Regurgitation
- Sponsor
- The Alfred
- Enrollment
- 10
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Is ambulatory, able and willing to comply with the study protocol and has provided written informed consent
- •Aged 18\-85 years, inclusive
- •Symptomatic with TR grade greater than or equal to 3\+
- •Preserved right ventricular function
- •In the opinion of the investigator and heart surgery team, the patient is not an appropriate candidate for tricuspid annuloplasty
Exclusion Criteria
- •In the opinion of the investigator and heart surgery team, the patient is an appropriate candidate for tricuspid annuloplasty
- •Haemodynamic instability (systolic pressure \< 90mmHg without after load reduction or cardiogenic shock or the need for inotropic support or intra\-aortic balloon pump)
- •Model for End\-stage Liver Disease (MELD score) \> 15
- •Suspected inability to adhere to adhere to follow\-up
- •Patients in whom TTE, TOE, (or MRI) is contraindicated
- •A known need for any other cardiac surgery
- •Inability to give informed consent
Outcomes
Primary Outcomes
Not specified
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