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

A First in Human Study to Assess Safety and Performance of the DaVingi™ System in the Treatment of Patients With Functional Tricuspid Regurgitation

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.

Study Overview

• Status: Recruiting
• Conditions: Functional Tricuspid Regurgitation (TR)
• Intervention / Treatment: Device: DaVingiTR System

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.

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Prague, Czechia
    • Recruiting
    • Na Homolce Hospital
    • Principal Investigator: Petr Neuzil, MD
    • Contact: Petr Moucka, Mgr; Phone Number: +420257272392; Email: Petr.Moucka@homolka.cz
• France
  • Paris, France
    • Recruiting
    • Institut Mutualiste Montsouris
    • Contact: Imane Bagdadi; Email: Imane.Bagdadi@imm.fr
    • Principal Investigator: Christophe Caussin, MD
  • Paris, France
    • Recruiting
    • Hôpital Bichat
    • Contact: Reza Farnoud, Dr.; Email: reza.farnoud.bch@aphp.fr
    • Principal Investigator: Marina Urena Alcazar, MD
  • Toulouse, France
    • Recruiting
    • Clinique Pasteur
    • Principal Investigator: Didier Tchetche, MD
    • Contact: Frederic Petit; Email: fpetit@clinique-pasteur.com
• Israel
  • Haifa, Israel, 3109601
    • Recruiting
    • Rambam Health Care Campus
    • Contact: Ludmila Helmer; Phone Number: +97247772180; Email: l_helmer@rambam.health.gov.il
    • Principal Investigator: Kerner Arthur, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DaVingiTR System Single Arm; single-arm, open label, multi-center study.	Device: DaVingiTR System; DaVingiTR Tricuspid valve annuloplasty repair device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety- the incidence and severity of device-related serious adverse device effects (SADE)	the incidence and severity of device-related serious adverse device effects (SADE) from time of index implant/ adjustment procedure through 30 days post-implant	from time of index implant/ adjustment procedure through 30 days post-implant
Device performance - Adjustment Device Technical Success: Rate of successful adjustment of the DaVingi™ TR ring at the tricuspid annulus, desired by physician	Implant Device Technical Success and Adjustment Device Technical Success	Immediately after procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
safety - Incidence of device-related major adverse cardiac events (MACE)	Incidence of device-related major adverse cardiac events (MACE)	30 days post procedure
safety - Rate of procedure-related serious adverse events (SAE)	Rate of procedure-related serious adverse events (SAE)	30 days post procedure

Collaborators and Investigators

• Sponsor: Cardiac Implants LLC

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2017
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: December 31, 2017
• First Submitted That Met QC Criteria: October 6, 2018
• First Posted (Actual): October 9, 2018

Study Record Updates

• Last Update Posted (Actual): November 12, 2021
• Last Update Submitted That Met QC Criteria: November 10, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Tricuspid Valve Insufficiency
• Other Study ID Numbers: CLP-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No