Clinical Trial Evaluation of the Percutaneous 4Tech TriCinch Coil Tricuspid Valve Repair System

Tricuspid Regurgitation Clinical Trial

Official title:

Clinical Trial Evaluation of the Percutaneous 4Tech TriCinch Coil Tricuspid Valve Repair System

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03294200
• Other study ID #: CIP 2101-01
• Status: Terminated
• Phase: N/A
• Start date: August 28, 2017
• Est. completion date: July 14, 2020

Study information

• Verified date: July 2020
• Source: 4Tech Cardio Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: July 14, 2020
• Est. primary completion date: July 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Tricuspid Regurgitation
• Tricuspid Valve Insufficiency

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Australia	Prince Charles Hospital	Chermside	Queensland
Australia	Monash Heart	Clayton	Victoria
Australia	St Vincent's Hospital	Darlinghurst	New South Wales
Belgium	AZ Sint Jan Brugge-Oostende AV	Brugge
Denmark	Rigshospitalet	Copenhagen
France	Clinique Pasteur	Toulouse
Germany	CardioVascular Center Frankfurt	Frankfurt am Main
Netherlands	St Antonius Hospital	Nieuwegein
Netherlands	Erasmus Medical Center	Rotterdam
United Kingdom	Brighton & Sussex University Hospitals - Sussex County Hospital	Brighton
United Kingdom	Leeds General Infirmary	Leeds
United Kingdom	Kings College Hospital	London
United Kingdom	John Radcliffe Hospital	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
4Tech Cardio Ltd.

Countries where clinical trial is conducted

Australia,  Belgium,  Denmark,  France,  Germany,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality of the Per Protocol cohort at 30 days post procedure.		30 days post procedure
Secondary	Number of individual adverse events related to the system or procedure.		30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure
Secondary	Echocardiographic changes compared to Baseline by means of echocardiographic semi-quantitative and quantitative measures		30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure
Secondary	Functional changes as compared to Baseline for New York Heart Association (NYHA) classification		30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure
Secondary	Rate of Heart Failure event post-procedure defined as a heart failure hospitalization or a heart failure hospitalization equivalent		30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure
Secondary	Exercise tolerance (Six Minute Walk Test)		30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure
Secondary	Quality of Life evaluation (Kansas City Cardiomyopathy Questionnaire).		30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure