Functional Tricuspid Regurgitation, Heart Valve Diseases, Tricuspid Valve Insufficiency
Conditions
Brief summary
The primary objective of the study is to generate feasibility safety and performance data for the 4Tech TriCinch Coil System in symptomatic patients suffering from moderate to severe functional tricuspid regurgitation with annular dilatation. The TriCinch Coil System is a percutaneous catheter-based medical device for tricuspid valve repair.
Interventions
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.
Sponsors
4Tech Cardio Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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. Major of age( ≥ 18 years old or older per local regulation) 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 and/or pulmonic valve stenosis and/or regurgitation more than or equal to moderate 6. Mitral 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All-cause mortality of the Per Protocol cohort at 30 days post procedure. | 30 days post procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Echocardiographic changes in Effective Regurgitant Orifice Area (EROA) compared to Baseline | 30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure | as assessed by the flow convergence method |
| 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 | The severity of patients' heart failure symptoms is assessed using the New York Heart Association (NYHA) classification. Patients are ranked from Class I (no limitation of physical activity) to Class IV (unable to carry on any physical activity without discomfort). |
| 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 | — |
| Exercise tolerance (Six Minute Walk Test) | 30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure | — |
| Quality of Life evaluation using the Kansas City Cardiomyopathy Questionnaire (KCCQ). | 30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure | The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. |
| 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 | — |
Countries
United States
Outcome results
None listed