First in Human Study of the DaVingi TR System in the Treatment of Patients With Functional Tricuspid Regurgitation

  • STATUS
    Recruiting
  • End date
    Jun 4, 2022
  • participants needed
    15
  • sponsor
    Cardiac Implants LLC
Updated on 4 February 2021
Investigator
Noa Avisar, Ph.D.
Primary Contact
Na Homolce Hospital (1.2 mi away) Contact
+5 other location

Summary

The DaVingi System is a percutaneous trans-catheter device delivered using right heart catheterization through the right internal jugular vein. The DaVingi System is designed for performing ring annuloplasty by using a Ring Delivery System to place a complete, flexible fabric ring around the annulus of the atrial side of the tricuspid valve. Fluoroscopy and echocardiography are used to monitor the ring placement procedure.

Description

The annuloplasty ring is a small multi-element ring, consisting of an outer fabric layer, a pre-set stakes array and internal adjustment cord that can be adjusted at a later stage after the outer layer of the ring and stakes are encapsulated in new tissue growth. Once implanted, the ring is designed to serve as a foundation for promoting new annular tissue growth, effectively growing a new adjustable annulus around the valve.

the study has been approved by Institutional Review Boards and Competent Authorities in Czech Republic, France and Israel.

Details
Condition Functional Tricuspid Regurgitation
Treatment DaVingiTR System
Clinical Study IdentifierNCT03700918
SponsorCardiac Implants LLC
Last Modified on4 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Severe tricuspid regurgitation as defined by American Society of Echocardiography
Symptoms of right ventricular failure despite appropriate medical therapy
Multidisciplinary heart team (minimum of three physicians, including cardiology and cardiac surgery representatives) recommends tricuspid annuloplasty
18 years old at time of enrollment
LVEF 30% within 45 days prior to index implant procedure
PASP < 70 mmHg via right heart catheterization (subject at rest) within 90 days prior to index implant procedure
Right Ventricle TAPSE 13 mm within 45 days prior to index implant procedure
Tricuspid valve annular diameter 40 mm as measured by baseline transthoracic echocardiography in the 4 chamber view within 45 days prior to index implant procedure
Subject has provided written informed consent
Subject agrees to comply with all required post-procedure follow-up visits, including device adjustment

Exclusion Criteria

Acutely decompensated heart failure (i.e. hemodynamically unstable or on IV inotropes)
Severe Right Ventricle dysfunction
Primary tricuspid pathology (e.g. rheumatic, congenital, infective, etc.)
Previous tricuspid valve repair or replacement
Transvalvular pacemaker or defibrillator lead is present
Severe left-sided valve disease
Right-sided intra-cardiac mass, thrombus or vegetation is present
Inability to properly guide the index implant procedure using Trans-esophagus echocardiography (e.g. acoustic window not adequate)
Subject requires chronic dialysis or renal replacement therapy
MI or known unstable angina within the 30-days prior to the implant index procedure
CVA within 3 months prior to index implant procedure
Bleeding disorders, active peptic ulcer or GI bleed
Contraindication to anticoagulation or antiplatelet medication, based on investigator's opinion
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)
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
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)
Female patients who are pregnant or lactating
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