A First-in-Human Study to Assess Safety and Performance of the Cardiac Implants Percutaneous Ring Annuloplasty System in the Treatment of Patients with Functional Tricuspid Regurgitatio

Withdrawn

• Conditions: 10046973; functional tricuspid regurgitation (TR)

• Registration Number: NL-OMON55204
• Lead Sponsor: Cardiac Implants LLC.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

1. Moderate to Severe functional tricuspid regurgitation (FTR) as defined by
ASE2.
2. Symptoms of right ventricular (RV) failure despite guideline directed
medical therapy, NYHA Class II-IV.
3. Multidisciplinary heart team (minimum of three physicians, including Imaging
and heart Failure cardiologists and cardiac surgery representatives) agree that
percutaneous tricuspid annuloplasty is a reasonable treatment option and
consider the subject to be a high risk for surgical annuloplasty.
4. >=18 years old at time of enrollment.
5. LVEF >= 30% within 45 days prior to index implant procedure.
6. PASP < 70 mmHg within 90 days prior to index implant procedure.
7. Right Ventricle TAPSE >= 13 mm within 45 days prior to index implant
procedure.
8. Tricuspid valve annular diameter >= 40 mm as measured by baseline TTE in the
4 chamber view within 45 days prior to index implant procedure.
9. Subject has provided written informed consent.
10. Subject agrees to comply with all required post-procedure follow-up visits,
including device adjustment.

Exclusion Criteria

1. Acutely decompensated heart failure (i.e. hemodynamically unstable or on IV
inotropes).
2. Severe RV dysfunction per ASE guidelines3.
3. Primary tricuspid pathology (e.g. rheumatic, congenital, infective, etc.).
4. Previous tricuspid valve repair or replacement.
5. Transvalvular pacemaker or defibrillator lead is present.
6. Severe left-sided valve disease.
7. Right-sided intra-cardiac mass, thrombus or vegetation is present.
8. Inability to properly guide the index implant procedure using TEE (e.g.
acoustic window not adequate).
9. MI or known unstable angina within the 30-days prior to the implant index
procedure.
10. CVA within 3 months prior to index implant procedure.
11. Bleeding disorders, active peptic ulcer or GI bleed.
12. Contraindication to anticoagulation or antiplatelet medication, based on
investigator*s opinion.
13. Chronic oral steroid or immunomodulator use (>= 6 months) or other condition
that could impair healing response (e.g. cardiac sarcoidosis or other chronic
inflammatory disease).
14. Any condition that, in the opinion of the investigator, may render the
subject unable to complete the study (life expectancy < 1 year), or lead to
difficulties for subject compliance with study requirements.
15. Subject is enrolled in another investigational study which has not
completed the required primary endpoint follow-up period (Note: patients
involved in a long-term surveillance phase of another study are eligible for
this study).
16. Female patients who are pregnant or lactating.

Study & Design

• Study Type: Interventional
• Study Design: Not specified