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Trial registered on ANZCTR


Registration number
ACTRN12617000829314
Ethics application status
Approved
Date submitted
31/05/2017
Date registered
6/06/2017
Date last updated
1/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Clinical Trial Evaluation of the Percutaneous 4Tech TriCinch Coil Tricuspid Valve Repair System
Scientific title
Assessment of the All Cause Mortality at 30 days for Patients suffering from Tricuspid Regurgitation implanted with the Percutaneous 4Tech TriCinch Coil System
Secondary ID [1] 292078 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
functional tricuspid regurgitation 303499 0
Condition category
Condition code
Cardiovascular 302918 302918 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients enrolled in this study with all eligibility criteria confirmed will be implanted with the TriCinch Coil System. This device offers a percutaneous treatment (access through the vein at the groin) to treat the leaking tricuspid valve, without the need for surgical intervention. This procedure is done by an interventional cardiologist or a cardiac surgeon under a general anaesthetic or deep sedation without the need for respiratory assistance and is expected to last 60-90 minutes initially.
The TriCinch Coil System implantation is as follows: 1) A delivery system that consists of a catheter (a hollow tube) that is attached to a handle is inserted in the patient's body through a vein in the groin. The delivery system contains a small anchor and a stent.
2) The small anchor is permanently placed in the wall of the tricuspid valve. The anchor is connected to a tensioning band that is connected to a stent at the opposite end. The stent (a mesh-like metal tube that expands, when deployed, to fit the patient's anatomy) is permanently deployed in a large vein called the inferior vena cave (IVC).
3) Then, the delivery system is removed and the procedure is complete.
Intervention code [1] 298221 0
Treatment: Devices
Comparator / control treatment
not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 302314 0
All-cause mortality of the Per Protocol cohort at 30 days post procedure.
Timepoint [1] 302314 0
30 days post procedure
Secondary outcome [1] 335446 0
Number of individual adverse events related to the system or procedure. Adverse Events will be assessed based on the available source documentation. Severity will be assessed per based on ISO 14155 definitions. Serious Adverse Events will be adjudicated by an independent Clinical Events Committee for their relationship to the device and/or the device procedure.
Timepoint [1] 335446 0
30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure
Secondary outcome [2] 335447 0
Echocardiographic changes compared to Baseline by means of echocardiographic semi-quantitative and quantitative measures (e.g. TV annular diameter, TV area, vena contracta, PISA EROA, Quantitative EROA, TV Regurgitant Volume, RA, RV, IVC dimensions, TAPSE). The independent Echo core lab measurements will be used to evaluate this secondary endpoint.
Timepoint [2] 335447 0
30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure
Secondary outcome [3] 335448 0
Functional changes as compared to Baseline for New York Heart Association (NYHA) classification,
Timepoint [3] 335448 0
30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure
Secondary outcome [4] 335449 0
Rate of Heart Failure event post-procedure defined as a heart failure hospitalization or a heart failure hospitalization equivalent
Timepoint [4] 335449 0
30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure
Secondary outcome [5] 335563 0
Exercise tolerance (Six Minute Walk Test)
Timepoint [5] 335563 0
30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure
Secondary outcome [6] 335564 0
Quality of Life evaluation (Kansas City Cardiomyopathy Questionnaire).
Timepoint [6] 335564 0
30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure
Secondary outcome [7] 337604 0
Changes in peripheral oedema will be evaluated using weight and diuretics dosage as a surrogate.
Timepoint [7] 337604 0
30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure
Secondary outcome [8] 337605 0
New onset of Atrial Fibrillation will be evaluated using the ECG collected at each follow-up visit
Timepoint [8] 337605 0
30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure
Secondary outcome [9] 337606 0
Change in average dosages of concomitant cardiac medications (including diuretics) will be evaluated based on the dosages reported on the medication form at each follow-up.
Timepoint [9] 337606 0
30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure
Secondary outcome [10] 337607 0
Kidney function will be evaluated using the creatinine and creatinine clearance levels (blood tests)
Timepoint [10] 337607 0
30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure
Secondary outcome [11] 337608 0
Change in NT Pro BNP will be evaluated through blood tests at each follow-up
Timepoint [11] 337608 0
30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure
Secondary outcome [12] 337609 0
Procedure time will be evaluated from first skin incision to skin closure (time)
Timepoint [12] 337609 0
Procedure
Secondary outcome [13] 337610 0
Radiation dose during the procedure will be evaluated from the X ray machine in the cath lab
Timepoint [13] 337610 0
Procedure
Secondary outcome [14] 337611 0
Technical success defined as (per MVARC) at post-procedure and 30 days post-procedure: absence of procedural mortality; and successful access, delivery, and retrieval of the device delivery system; and successful deployment and correct positioning of the first intended device; and freedom from emergency surgery or reintervention related to the device or access procedure.
Timepoint [14] 337611 0
post-procedure and 30 days post-procedure

Eligibility
Key inclusion criteria
1. Moderate to severe functional tricuspid regurgitation (TR) defined as: TR severity 2+ to 4+ (according to semi-quantitative echocardiographic color flow doppler evaluation); and Annular diameter greater or equal to 40 mm confirmed by echocardiography
2. 18 years old or older
3. Subject has read and signed the informed consent prior to study related procedures.
4. Willing and able to comply with all required follow-up evaluations and assessments.
5. The 'Heart Team' assessment recommends TriCinch Coil Implantation
NOTE: At this time, the Heart team will not recommend TriCinch Coil Implantation on patients with a history of cardiac surgery.
NOTE 2: The Heart team will recommend TriCinch Coil implantation for patients classified as high-risk for open heart surgery.
6. New York Heart Associate Classification greater or equal to II.
7. Left Ventricular Ejection Fraction greater or equal to 30%.
8. Heart failure symptoms (such as fluid retention and severe oedema, liver stasis) despite on optimized medical therapy by the local heart team; at minimum subject on diuretic use
9. Subject has suitable anatomy for investigational device implantation as per imaging requirements
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Currently participating in another investigational drug or device study.
2. Subject with Systolic pulmonary arterial pressure (sPAP) > 60mmHg as measured by Transthoracic Echocardiography (TTE)
NOTE: In case the sPAP measured by TTE is 60 mmHg or more, a right heart catheter should be performed during screening to confirm whether or not the patient can be enrolled into the study
3. Subject requiring another cardiac procedure in the framework of the index procedure; subject requiring a percutaneous procedure within 30 days before or after the procedure or a cardiac surgical procedure within 3 months before or after the procedure
4. Moderate or Severe tricuspid valve stenosis (defined as a mean gradient greater or equal to 5 mmHg at normal heart rate)
5. Aortic, mitral and/or pulmonic valve stenosis and/or regurgitation more than moderate
6. Intra-cardiac thrombus, mass or vegetation requiring active treatment.
7. Implanted inferior vena cava (IVC) filter.
8. Prior tricuspid repair or tricuspid replacement
9. Known allergy to contrast media, silicone, PET, Co-Cr, stainless steel or nitinol that cannot be adequately pre-medicated
10. History of cardiac transplantation
11. Contraindication to Transthoracic/Transoesophageal Echocardiography (TTE/TOE).
12. Endocarditis or severe infection within 12 months of scheduled implant procedure
13. Myocardial Infarction (MI) or known unstable angina within the 30 days prior to the index procedure
14. Cerebro Vascular Accident within the previous 6 months
15. Hemodynamic instability or on IV inotropes
16. Contraindication to anticoagulant therapy and antiplatelet therapy
17. Documented history of bleeding diathesis, hypercoagulable or active peptic ulcer or gastrointestinal bleeding within 3 months of scheduled implant procedure
18. Severe renal impairment or on dialysis
19. Life expectancy less than 12 months.
20. Acute anemia
21. Chronic Oral Steroid Use greater or equal to 6 months
22. Pregnant or lactating female of childbearing potential with a positive pregnancy test 24 hours before any study-related radiation exposure
23. Pulmonary embolism within the last 6 months
24. Tricuspid Valve Tethering distance > 10 mm
25. Presence of trans-tricuspid pacemaker or defibrillator leads which are determined as immobile or interfering with the procedure, as evaluated by echocardiography.
26. Contra-indicated for blood transfusion or refuses transfusion
27. Patient undergoing emergency treatment
28. Patient without appropriate venous access

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
Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
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)
NSW,QLD,VIC
Recruitment outside Australia
Country [1] 8940 0
France
State/province [1] 8940 0
Country [2] 8941 0
Denmark
State/province [2] 8941 0
Country [3] 8942 0
Netherlands
State/province [3] 8942 0
Country [4] 8943 0
Germany
State/province [4] 8943 0
Country [5] 8944 0
United Kingdom
State/province [5] 8944 0
Country [6] 9128 0
Canada
State/province [6] 9128 0
Quebec, British Columbia

Funding & Sponsors
Funding source category [1] 296611 0
Commercial sector/Industry
Name [1] 296611 0
4Tech Cardio, Ltd. a wholly owned subsidiary of 4Tech Inc, a Delaware corporation
Address [1] 296611 0
Ballybrit Business Park
Unit 3
Galway, H91DT7C

Country [1] 296611 0
Ireland
Primary sponsor type
Commercial sector/Industry
Name
4Tech Cardio, Ltd. a wholly owned subsidiary of 4Tech Inc, a Delaware corporation
Address
Ballybrit Business Park
Unit 3
Galway, H91DT7C
Country
Ireland
Secondary sponsor category [1] 295571 0
Commercial sector/Industry
Name [1] 295571 0
Mobius Medical Pty Ltd
Address [1] 295571 0
Suite 1002
23 Hunter Street
Sydney NSW 2000
Country [1] 295571 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297839 0
The Monash Health Human Research Ethics Committee (HREC)
Ethics committee address [1] 297839 0
Monash Health, 246 Clayton Road, Clayton, Victoria, 3168
Ethics committee country [1] 297839 0
Australia
Date submitted for ethics approval [1] 297839 0
19/04/2017
Approval date [1] 297839 0
23/06/2017
Ethics approval number [1] 297839 0
Initial protocol approval

Summary
Brief summary
The purpose of this clinical study is to evaluate a new, medical device called the TriCinch Coil System. This is an early phase study. This device is designed to treat patients suffering from tricuspid valve disease, It has not been approved by the Therapeutic Goods Administration (TGA) as a treatment for tricuspid valve regurgitation in Australia.,
The study is a multi-centre study, which means that up to 20 hospitals may be participating in this study. Implantation of the TriCinch Coil System will be attempted in up to 90 patients in this study.
The goal of this clinical study is to evaluate the safety and performance of the TriCinch Coil System as a new method to treat leaking tricuspid valves which cause regurgitation (backflow of blood). Through the trial, information will be collected about the safety of the device, the success of placing the device, and its ability to reduce tricuspid regurgitation in a less invasive way for patients who have a high risk for undergoing open-heart surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75234 0
Dr Robert Gooley
Address 75234 0
Monash Heart, Level 2
246 Clayton Road
Clayton,
VIC 3168
Country 75234 0
Australia
Phone 75234 0
+61 3 9594 2680
Fax 75234 0
Email 75234 0
Robert.Gooley@monashhealth.org
Contact person for public queries
Name 75235 0
Mr Julien Delumeau
Address 75235 0
4TECH Cardio Ltd
Ballybrit Business Park
Unit 3
Galway, H91DT7C
Country 75235 0
Ireland
Phone 75235 0
+33 7 85 10 59 70
Fax 75235 0
Email 75235 0
Julien.Delumeau@4tech.ie
Contact person for scientific queries
Name 75236 0
Mr Julien Delumeau
Address 75236 0
4TECH Cardio Ltd
Ballybrit Business Park
Unit 3
Galway, H91DT7C
Country 75236 0
Ireland
Phone 75236 0
+33 7 85 10 59 70
Fax 75236 0
Email 75236 0
Julien.Delumeau@4tech.ie

No data has been provided for results reporting
Summary results
Not applicable