Clinical trial NCT03700918: First in Human Study of the DaVingi™ TR System in the Treatment of Patients With Functional Tricuspid Regurgitation
Official title: A First in Human Study to Assess Safety and Performance of the DaVingi™ System in the Treatment of Patients With Functional Tricuspid Regurgitation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Functional Tricuspid Regurgitation (TR)
Lead sponsor: Cardiac Implants LLC
Sponsor class: INDUSTRY
First posted: 2018-10-09
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: First in human
Primary purpose: DEVICE_FEASIBILITY

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

1. Severe tricuspid regurgitation as defined by American Society of Echocardiography.
2. Symptoms of right ventricular failure despite appropriate medical therapy.
3. Multidisciplinary heart team (minimum of three physicians, including cardiology and cardiac surgery representatives) recommends tricuspid annuloplasty.
4. ≥18 years old at time of enrollment.
5. LVEF ≥ 30% within 45 days prior to index implant procedure.
6. PASP \< 70 mmHg via right heart catheterization (subject at rest) 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 transthoracic echocardiography 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 Right Ventricle dysfunction.
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 Trans-esophagus echocardiography (e.g. acoustic window not adequate).
9. Subject requires chronic dialysis or renal replacement therapy.
10. MI or known unstable angina within the 30-days prior to the implant index procedure.
11. CVA within 3 months prior to index implant procedure.
12. Bleeding disorders, active peptic ulcer or GI bleed.
13. Contraindication to anticoagulation or antiplatelet medication, based on investigator's opinion.
14. 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).
15. 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.
16. 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).
17. Female patients who are pregnant or lactating.

Primary outcomes:
measure: Safety- the incidence and severity of device-related serious adverse device effects (SADE)
timeFrame: from time of index implant/ adjustment procedure through 30 days post-implant
measure: Device performance - Adjustment Device Technical Success: Rate of successful adjustment of the DaVingi™ TR ring at the tricuspid annulus, desired by physician
timeFrame: Immediately after procedure
Secondary outcomes:
measure: safety - Incidence of device-related major adverse cardiac events (MACE)
timeFrame: 30 days post procedure
measure: safety - Rate of procedure-related serious adverse events (SAE)
timeFrame: 30 days post procedure
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Na Homolce Hospital
city: Paris
country: France
facility: Hopital Bichat
city: Paris
country: France
facility: Institut Mutualiste Montsouris
city: Toulouse
country: France
facility: Clinique Pasteur
city: Haifa
country: Israel
facility: Rambam Health Care Campus
Study officials:
affiliation: Cardiac Implants LLC
name: Nodar Kipshidze, MPH
role: STUDY_DIRECTOR
References: