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

NCT03700918 | Unknown

• 1 other identifier: CLP-001
• Study Type: interventional
• Target: 15
• Locations: 3 countries
• Sites: 5

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.

Conditions

Functional Tricuspid Regurgitation (TR)

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• safety - Incidence of device-related major adverse cardiac events (MACE)

  30 days post procedure

• safety - Rate of procedure-related serious adverse events (SAE)

  30 days post procedure

Study Arms (1)

DaVingiTR System Single Arm

EXPERIMENTAL

single-arm, open label, multi-center study.

Device: DaVingiTR System

Interventions

DaVingiTR System DEVICE

DaVingiTR Tricuspid valve annuloplasty repair device

DaVingiTR System Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cardiac Implants LLC: lead

Study Sites (5)

Na Homolce Hospital

Prague, Czechia

RECRUITING

Hopital Bichat

Paris, France

RECRUITING

Institut Mutualiste Montsouris

Paris, France

RECRUITING

Clinique Pasteur

Toulouse, France

RECRUITING

Rambam Health Care Campus

Haifa, 3109601, Israel

RECRUITING

Study Officials

• Nodar Kipshidze, MPH

  Cardiac Implants LLC

  STUDY DIRECTOR

Central Study Contacts

Nodar Kipshidze, MPH

CONTACT

1-917-370-6247; Nodar@cardiac-implants.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: First in human

Study Record Dates

• First Submitted: December 31, 2017
• First Posted: October 9, 2018
• Study Start: November 11, 2017
• Primary Completion: December 1, 2021
• Study Completion: June 1, 2022
• Last Updated: November 12, 2021

Record last verified: 2021-11

Locations

FR (3); IL (1); CZ (1)