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Trial registered on ANZCTR


Registration number
ACTRN12620000564954p
Ethics application status
Submitted, not yet approved
Date submitted
9/04/2020
Date registered
14/05/2020
Date last updated
14/05/2020
Date data sharing statement initially provided
14/05/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of repairing the heart valve with CardioCel®
Scientific title
Evaluation of Outcomes Following Tricuspid Valve Cylinder Reconstruction with CardioCel® in Isolated Severe Tricuspid Regurgitation
Secondary ID [1] 300962 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tricuspid Regurgitation 316983 0
Condition category
Condition code
Cardiovascular 315147 315147 0 0
Other cardiovascular diseases
Surgery 315436 315436 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 317292 0
Treatment: Surgery
Intervention code [2] 317490 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323420 0
Residual tricuspid regurgitation on TTE

Timepoint [1] 323420 0
12 months and 24 months postoperatively
Primary outcome [2] 323687 0
Right ventricular function on TTE
Timepoint [2] 323687 0
12 months and 24 months postoperatively
Secondary outcome [1] 381882 0
Reintervention for tricuspid valve will be assessed by patient medical records
Timepoint [1] 381882 0
12 months and 24 months postoperatively
Secondary outcome [2] 382580 0
Permanent pacemaker implantation will be assessed by patient medical records
Timepoint [2] 382580 0
12 months and 24 months postoperatively
Secondary outcome [3] 382581 0
Prosthetic valve infection will be assessed by patient medical records
Timepoint [3] 382581 0
12 months and 24 months postoperatively

Eligibility
Key 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
Minimum age
18 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
This is an exploratory study and the sample size is pragmatically designed. Descriptive statistics will be analysed using SPSS statistical package. Parametric data will be reported as means (standard deviations), non-parametric data will be presented as median with an interquartile range, and categorical data presented as frequencies and percentages.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 16406 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 29951 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 305408 0
Hospital
Name [1] 305408 0
The Alfred
Address [1] 305408 0
55 Commerical Road
Melbourne VIC 3004
Country [1] 305408 0
Australia
Primary sponsor type
Hospital
Name
The Alfred
Address
55 Commerical Road
Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 305806 0
None
Name [1] 305806 0
Address [1] 305806 0
Country [1] 305806 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 305731 0
The Alfred Ethics Committee
Ethics committee address [1] 305731 0
55 Commercial Rd
Melbourne VIC 3004
Ethics committee country [1] 305731 0
Australia
Date submitted for ethics approval [1] 305731 0
21/10/2019
Approval date [1] 305731 0
Ethics approval number [1] 305731 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101386 0
Dr Atsuo Doi
Address 101386 0
Alfred Hospital
Department of Cardiothoracic Surgery and Transplantation
55 Commercial Rd
Melbourne VIC 3004
Country 101386 0
Australia
Phone 101386 0
+6139076 3133
Fax 101386 0
Email 101386 0
a.doi@alfred.org.au
Contact person for public queries
Name 101387 0
Dr Christina Kure
Address 101387 0
Alfred Hospital
Department of Cardiothoracic Surgery and Transplantation
55 Commercial Rd
Melbourne VIC 3004
Country 101387 0
Australia
Phone 101387 0
+6139076 3133
Fax 101387 0
Email 101387 0
a.doi@alfred.org.au
Contact person for scientific queries
Name 101388 0
Dr Atsuo Doi
Address 101388 0
Alfred Hospital
Department of Cardiothoracic Surgery and Transplantation
55 Commercial Rd
Melbourne VIC 3004
Country 101388 0
Australia
Phone 101388 0
+6139076 3133
Fax 101388 0
Email 101388 0
a.doi@alfred.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
To protect the privacy of research participants
What supporting documents are/will be available?
Study protocol
Informed consent form
How or where can supporting documents be obtained?
Type [1] 7577 0
Study protocol
Citation [1] 7577 0
Link [1] 7577 0
Email [1] 7577 0
a.doi@alfred.org.au
Other [1] 7577 0
Attachment [1] 7577 0
Type [2] 7578 0
Informed consent form
Citation [2] 7578 0
Link [2] 7578 0
Email [2] 7578 0
a.doi@alfred.org.au
Other [2] 7578 0
Attachment [2] 7578 0
Summary results
No Results