First in Human Study of the DaVingi™ TR System in the Treatment of Patients With Functional Tricuspid Regurgitation
NCT ID: NCT03700918
Last Updated: 2021-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
15 participants
INTERVENTIONAL
2017-11-11
2022-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
the study has been approved by Institutional Review Boards and Competent Authorities in Czech Republic, France and Israel.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
DaVingiTR System Single Arm
single-arm, open label, multi-center study.
DaVingiTR System
DaVingiTR Tricuspid valve annuloplasty repair device
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
DaVingiTR System
DaVingiTR Tricuspid valve annuloplasty repair device
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cardiac Implants LLC
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Nodar Kipshidze, MPH
Role: STUDY_DIRECTOR
Cardiac Implants LLC
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Na Homolce Hospital
Prague, , Czechia
Hopital Bichat
Paris, , France
Institut Mutualiste Montsouris
Paris, , France
Clinique Pasteur
Toulouse, , France
Rambam Health Care Campus
Haifa, , Israel
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Petr Moucka, Mgr
Role: primary
Reza Farnoud, Dr.
Role: primary
Imane Bagdadi
Role: primary
Frederic Petit
Role: primary
Ludmila Helmer
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CLP-001
Identifier Type: -
Identifier Source: org_study_id