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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03294200




Registration number
NCT03294200
Ethics application status
Date submitted
22/09/2017
Date registered
26/09/2017
Date last updated
31/07/2020

Titles & IDs
Public title
Clinical Trial Evaluation of the Percutaneous 4Tech TriCinch Coil Tricuspid Valve Repair System
Scientific title
Clinical Trial Evaluation of the Percutaneous 4Tech TriCinch Coil Tricuspid Valve Repair System
Secondary ID [1] 0 0
CIP 2101-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tricuspid Regurgitation 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - TriCinch Coil System implantation

Experimental: Tricinch Coil System treatment -


Treatment: Devices: TriCinch Coil System implantation
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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
All-cause mortality of the Per Protocol cohort at 30 days post procedure.
Timepoint [1] 0 0
30 days post procedure
Secondary outcome [1] 0 0
Number of individual adverse events related to the system or procedure.
Timepoint [1] 0 0
30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure
Secondary outcome [2] 0 0
Echocardiographic changes compared to Baseline by means of echocardiographic semi-quantitative and quantitative measures
Timepoint [2] 0 0
30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure
Secondary outcome [3] 0 0
Functional changes as compared to Baseline for New York Heart Association (NYHA) classification
Timepoint [3] 0 0
30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure
Secondary outcome [4] 0 0
Rate of Heart Failure event post-procedure defined as a heart failure hospitalization or a heart failure hospitalization equivalent
Timepoint [4] 0 0
30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure
Secondary outcome [5] 0 0
Exercise tolerance (Six Minute Walk Test)
Timepoint [5] 0 0
30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure
Secondary outcome [6] 0 0
Quality of Life evaluation (Kansas City Cardiomyopathy Questionnaire).
Timepoint [6] 0 0
30 days, three (3), six (6), twelve (12) and twenty-four (24) months 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 = 40 mm confirmed by echocardiography

2. = 18 years old

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

6. New York Heart Associate Classification = II.

7. Left Ventricular Ejection Fraction = 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
Sex
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)

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 =5 mmHg at
normal heart rate)

5. Aortic, mitral and/or pulmonic valve stenosis and/or regurgitation more than or equal
to moderate

6. Mitral valve stenosis and/or regurgitation more than moderate

7. Intra-cardiac thrombus, mass or vegetation requiring active treatment.

8. Implanted inferior vena cava (IVC) filter.

9. Prior tricuspid repair or tricuspid replacement

10. Known allergy to contrast media, silicone, PET, Co-Cr, stainless steel or nitinol that
cannot be adequately pre-medicated

11. History of cardiac transplantation

12. Contraindication to Transthoracic/Transoesophageal Echocardiography (TTE/TOE).

13. Endocarditis or severe infection within 12 months of scheduled implant procedure

14. Myocardial Infarction (MI) or known unstable angina within the 30 days prior to the
index procedure

15. Cerebro Vascular Accident within the previous 6 months

16. Hemodynamic instability or on IV inotropes

17. Contraindication to anticoagulant therapy and antiplatelet therapy

18. Bleeding disorders or hypercoagulable condition (at risk of blood clots)

19. Active peptic ulcer or active GI bleeding within 3 months of scheduled implant
procedure

20. Severe renal impairment or on dialysis

21. Life expectancy less than 12 months.

22. Acute anemia

23. Chronic Oral Steroid Use = 6 months

24. Pregnant or lactating female of childbearing potential with a positive pregnancy test
24 hours before any study-related radiation exposure

25. Pulmonary embolism within the last 6 months

26. Tricuspid Valve Tethering distance > 10 mm

27. Presence of trans-tricuspid pacemaker or defibrillator leads which are determined as
immobile or interfering with the procedure, as evaluated by echocardiography.

28. Contra-indicated for blood transfusion or refuses transfusion

29. Patient undergoing emergency treatment

30. Patient without appropriate venous access

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/08/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/07/2020
Sample size
Target
Accrual to date
Final
18
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
St Vincent's Hospital - Darlinghurst
Recruitment hospital [2] 0 0
Prince Charles Hospital - Chermside
Recruitment hospital [3] 0 0
Monash Heart - Clayton
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
4032 - Chermside
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Brugge
Country [2] 0 0
Denmark
State/province [2] 0 0
Copenhagen
Country [3] 0 0
France
State/province [3] 0 0
Toulouse
Country [4] 0 0
Germany
State/province [4] 0 0
Frankfurt am Main
Country [5] 0 0
Netherlands
State/province [5] 0 0
Nieuwegein
Country [6] 0 0
Netherlands
State/province [6] 0 0
Rotterdam
Country [7] 0 0
United Kingdom
State/province [7] 0 0
Brighton
Country [8] 0 0
United Kingdom
State/province [8] 0 0
Leeds
Country [9] 0 0
United Kingdom
State/province [9] 0 0
London
Country [10] 0 0
United Kingdom
State/province [10] 0 0
Oxford

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
4Tech Cardio Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The objective of the study is to generate safety and performance data for the 4Tech TriCinch
Coil System in symptomatic patients suffering from significant functional tricuspid
regurgitation with annular dilatation.

The TriCinch Coil System is a percutaneous catheter-based medical device for tricuspid valve
repair.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03294200
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03294200