Percutaneous ring annuloplasty for treating tricuspid regurgitation

Early Feasibility Study (EFS) of the Cardiac Implants Percutaneous Ring Annuloplasty System for the Treatment of Functional Tricuspid Regurgitation

This study is testing a new device to see if it can safely help people with moderate to severe tricuspid regurgitation feel better by reducing the size of the heart's tricuspid valve.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Cardiac Implants LLC (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 2 sites (Hackensack, New Jersey and 1 other locations)
• Trial ID: NCT04890821 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and performance of the Cardiac Implants Percutaneous Ring Annuloplasty System in patients with moderate to severe functional tricuspid regurgitation. It involves a multi-center, prospective approach where the device is implanted via a transcatheter method through the right internal jugular vein. After approximately 90 days, the ring is adjusted to optimize the reduction of the tricuspid annulus dimension, with outcomes assessed through echocardiographic and quality of life measures.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with moderate to severe functional tricuspid regurgitation who have not responded adequately to medical therapy.

Not a fit: Patients with mild tricuspid regurgitation or those who do not have suitable anatomy for the device implantation may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a minimally invasive option for patients suffering from significant tricuspid regurgitation, potentially improving their heart function and quality of life.

How similar studies have performed: Other studies have shown promise with similar transcatheter approaches for valve repair, indicating potential for success in this novel application.

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.

Where this trial is running

Hackensack, New Jersey and 1 other locations

• Hackensack University Medical Center — Hackensack, New Jersey, United States (Not_yet_recruiting)
• Weill Cornell Medicine-New York Presbyterian Hospital — New York, New York, United States (Recruiting)

Study contacts

• Study coordinator: Nodar Kipshidze, MPH

Conditions Tricuspid Regurgitation Functional; Tricuspid Valve; Annular Dilatation; Annuloplasty; Tricuspid Valve Repair