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

Recruiting

• Conditions: Functional tricuspid regurgitation with annular dilatation.; 10046973

• Registration Number: NL-OMON50495
• Lead Sponsor: 4 Tech Cardio Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 15

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. NOTE: At
this time, the Heart team will not recommend TriCinch Coil Implantation on
patients with a history of cardiac surgery. For more information, refer to
Section 8.1.1.
NOTE 2: The Heart team will recommend TriCinch Coil implantation for patients
classified as high-risk for open heart surgery. For more information, refer to
Section 8.1.
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)
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 >=5
mmHg at normal heart rate)
5. Aortic 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 dual 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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>All-cause mortality of the primary endpoint cohort at 30 days post procedure. </p><br>