Early Feasibility Study of the Cardiac Implants Percutaneous Ring Annuloplasty System

Launched by CARDIAC IMPLANTS LLC · May 12, 2021

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment for patients with moderate to severe tricuspid regurgitation, a condition where the heart's tricuspid valve does not close properly, leading to blood flowing backward into the heart. The study is focused on a device called the Cardiac Implants annuloplasty ring, which is delivered through a small tube inserted into the body. The trial aims to assess how safe and effective this method is, including the possibility of adjusting the ring about 90 days after it is implanted.

To participate in this study, individuals must be at least 18 years old and have been diagnosed with moderate to severe tricuspid regurgitation. They should also have symptoms of right heart failure despite taking medications. Participants will work with a team of doctors who specialize in heart conditions and will undergo evaluations to ensure they meet certain health criteria. If eligible, they can expect close monitoring during and after the procedure to track their progress and any changes in their condition. This trial is currently recruiting participants, and it’s an opportunity for those affected to potentially benefit from a new treatment approach.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Moderate to severe functional tricuspid regurgitation (TR) defined by ASE guidelines and the European Association of Echocardiography guidelines.
• • 2. Tricuspid valve annular diameter ≥ 40mm or \> 21 mm/m2 as measured by baseline TTE in a 4-chamber view within 90 days prior to index implant procedure.
• • 3. Age ≥ 18 years old at the time of enrollment.
• • 4. New York Heart Associate Classification ≥ II.
• • 5. Symptoms of right heart failure despite optimized medical therapy.
• • 6. Multidisciplinary heart team (minimum of four physicians, including imaging, Structural Heart Disease Interventionalist, Heart Failure Cardiologist, and Cardiac Surgeon) agree that percutaneous tricuspid annuloplasty is a reasonable treatment.
• • 7. Left Ventricular Ejection Fraction (LVEF) ≥ 30% within 90 days prior to index implant procedure
• • 8. The subject has suitable anatomy for investigational device implantation as per imaging requirements.
• • 9. The subject has read and signed the informed consent prior to study related procedures.
• • 10. The subject is willing and able to comply with all required follow-up evaluations and assessments.
• Exclusion Criteria:
• • 1. Acute decompensated heart failure requiring hospital admission with 4 weeks of enrollment.
• • 2. Severe RV dysfunction as assessed by echocardiography.
• • 3. Primary (organic) tricuspid pathology (e.g. rheumatic, congenital, infective, etc.).
• • 4. Currently participating in another investigational drug or device study.
• • 5. Systolic pulmonary arterial pressure (sPAP) \> 70 mmHg as measured by Transthoracic Echocardiography (TTE).
• • 6. 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.
• • 7. Tricuspid valve stenosis.
• • 8. Aortic, mitral and/or pulmonic valve stenosis and/or regurgitation more than moderate.
• • 9. Intra-cardiac thrombus, mass or vegetation requiring active treatment.
• • 10. Prior tricuspid repair or tricuspid replacement.
• • 11. Known allergy to contrast media, stainless steel or nitinol that cannot be adequately pre-medicated.
• • 12. History of cardiac transplantation.
• • 13. Contraindication to Transthoracic/Transesophageal Echocardiography (TTE/TEE).
• • 14. Endocarditis or severe infection within 12 months of scheduled implant procedure.
• • 15. Myocardial Infarction (MI), percutaneous coronary intervention (PCI), or known unstable angina within the 60 days prior to the index procedure.
• • 16. Cerebro-Vascular Accident within the previous 3 months.
• • 17. Hemodynamic instability or on IV inotropes.
• • 18. Contraindication to anticoagulant therapy and dual antiplatelet therapy.
• • 19. Documented history of bleeding diathesis, hypercoagulable or active peptic ulcer or gastrointestinal bleeding within 3 months of scheduled implant procedure.
• • 20. Severe renal impairment or on dialysis.
• • 21. Any condition that, in the opinion of the investigator, may render the subject unable to complete the study (e.g. life expectancy \< 1 year), or lead to difficulties for subject compliance with study requirements.
• • 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 transvalvular pacemaker or defibrillator leads which are determined as immobile or interfering with the procedure, as evaluated by echocardiography.
• • 28. Inadequate TEE acoustic window for appropriate visualization of the tricuspid valve that is required for guiding the index implant procedure.
• • 29. Contra-indicated for blood transfusion or refuses transfusion.
• • 30. Patient undergoing emergency treatment.
• • 31. Patient without appropriate jugular access.