None listed
Conditions
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.
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, 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
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.
Sponsors
4Tech Cardio, Ltd. a wholly owned subsidiary of 4Tech Inc, a Delaware corporation
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
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 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
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
Outcome results
None listed