Effectiveness of repairing the heart valve with CardioCel®

Not Applicable

Recruiting

• Conditions: Tricuspid Regurgitation; Cardiovascular - Other cardiovascular diseases; Surgery - Surgical techniques

• Registration Number: ACTRN12620000564954
• Lead Sponsor: The Alfred

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-14
• Last Update Posted: 19 September 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Residual tricuspid regurgitation on TTE<br><br>[12 months and 24 months postoperatively];Right ventricular function on TTE[12 months and 24 months postoperatively]

Secondary Outcome Measures

Name	Time	Method
Reintervention for tricuspid valve will be assessed by patient medical records[12 months and 24 months postoperatively];Permanent pacemaker implantation will be assessed by patient medical records[12 months and 24 months postoperatively];Prosthetic valve infection will be assessed by patient medical records[12 months and 24 months postoperatively]