None listed
Conditions
Brief summary
Patients with severe tricuspid valve regurgitation (TVR) not amenable to repair have conventionally undergone replacement with either a mechanical or bioprosthetic valve. These prostheses carry issues regarding anticoagulation management, and risks of thrombotic complications and structural valve deterioration. CardioCel® is bovine pericardium that is subjected to an anticalcification tissue engineering process (ADAPT TEP®) and reduces cytotoxicity by removing lipids, cells and cell remnants, nucleic acids and a-Gal (galactosyl) epitopes. Studies have suggested minimal to no evidence of calcification at 24 mths and resistance to infection. We aim to evaluate the safety and effectiveness of a cylinder reconstruction of the TV with CardioCel® in patients with isolated severe TV requiring surgical intervention who would have otherwise required TVR with a prosthetic valve. We will determine whether reconstruction of the TV with CardioCel® bovine pericardial sheet is comparable with traditional treatment in the early period after surgery and to assess heart function up to 2 years’ post-surgery. The potential outcome will be increasing the number of patients with severe TVR treated surgically to prevent deterioration of heart function.
Interventions
The aim of this project is to evaluate the safety and effectiveness of repair / reconstruction of the tricuspid valve using a new pericardial sheet called CardioCel® and a surgical technique called cylinder reconstruction in a maximum of 10 patients with isolated severe tricuspid regurgitation.
In this research project we will be using an improved bovine pericardium sheet called CardioCel® to replace the tricuspid valve at The Alfred hospital. CardioCel® is specially engineered (using the ADAP
The aim of this project is to evaluate the safety and effectiveness of repair / reconstruction of the tricuspid valve using a new pericardial sheet called CardioCel® and a surgical technique called cylinder reconstruction in a maximum of 10 patients with isolated severe tricuspid regurgitation. In this research project we will be using an improved bovine pericardium sheet called CardioCel® to replace the tricuspid valve at The Alfred hospital. CardioCel® is specially engineered (using the ADAPT TEP® technique), to reduce the risk of calcium developing on these tissues, a common cause of the tissue valve problems. Another novel aspect of this study will involve using a different technique called ‘cylinder reconstruction’ to treat tricuspid valve regurgitation. Instead of replacing the tricuspid valve with a prosthetic valve, as per standard practice, the surgeon in this study (Dr Doi) will repair/reconstruct the tricuspid valve with a cylindrical tube shaped similar to a native valve using the CardioCel®. This technique using a cylinder tube allows the new valve to be attached to the heart chamber itself, which may have a positive effect in preserving the heart function in the long term compared to conventional valve replacements where the prosthetic valve is only sutured (stitched) to the rim (annulus) of the native valve. The choice of suture placement will be dependent on the experienced cardiothoracic study surgeon’s (Dr Doi) preference. The approximate duration of the surgery will be 2-4 hours. If the TVCR is deemed unsuccessful on the intraoperative transthoracic oesophageal echocardiogram (TOE), then TVR with conventional bioprosthetic valve will be performed. If a participant withdraws from the study prior to the surgery, they will receive a TVR with conventional bioprosthetic valve. If the participant chooses to withdraw from the study following the surgery, they will be followed up as per usual valve surgery patients. The study objective is to determine whether reconstruction of the tricuspid valve with CardioCel® bovine pericardial sheet is comparable with valve replacement with a mechanical or tissue prosthesis in the early period after surgery and also to assess the heart function up to 2 years after the surgery. The potential study outcome will be implementation of this technique in patients with severe tricuspid valve regurgitation. This may increase the number of patients treated surgically to prevent deterioration of heart function.
Sponsors
The Alfred
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
No
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
Outcome results
None listed