Brief Summary
Prospective, multi-center study to assess safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System
Brief Title
The TRICURE EFS Study
Detailed Description
The study is a multi-center, prospective single arm study designed to evaluate the safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System.
Central Contacts
Central Contact Role
Contact
Central Contact Phone
+41796015318
Central Contact Email
gerteis@tricares.de
Completion Date
Completion Date Type
Estimated
Conditions
Tricuspid Valve Regurgitation
Heart Valve Diseases
Cardiovascular Diseases
Eligibility Criteria
Inclusion Criteria:
* Adult patients
* Tricuspid regurgitation grade 3 (severe) on a scale of 0 (none) to 5 (torrential)
* Institutional Heart Team evaluates patient as being at increased operative risk
Exclusion Criteria:
* Patient in need of emergent intervention
* Patient who is hemodynamically unstable
* Anatomical contraindications for implantation with study device
* Patient who is currently participating in another clinical investigation where the primary endpoint was not reached yet
* Adult patients
* Tricuspid regurgitation grade 3 (severe) on a scale of 0 (none) to 5 (torrential)
* Institutional Heart Team evaluates patient as being at increased operative risk
Exclusion Criteria:
* Patient in need of emergent intervention
* Patient who is hemodynamically unstable
* Anatomical contraindications for implantation with study device
* Patient who is currently participating in another clinical investigation where the primary endpoint was not reached yet
Inclusion Criteria
Inclusion Criteria:
* Adult patients
* Tricuspid regurgitation grade 3 (severe) on a scale of 0 (none) to 5 (torrential)
* Institutional Heart Team evaluates patient as being at increased operative risk
* Adult patients
* Tricuspid regurgitation grade 3 (severe) on a scale of 0 (none) to 5 (torrential)
* Institutional Heart Team evaluates patient as being at increased operative risk
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT06506942
Org Class
Industry
Org Full Name
TRiCares
Org Study Id
2301
Overall Status
Recruiting
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
The TRICURE EFS TRiCares Topaz Transfemoral TRICUspid Heart Valve REplacement System Early Feasibility Study
Primary Outcomes
Outcome Description
Composite rate of major adverse events (MAEs) at 30 days, including mortality, myocardial infarction, stroke and major complications.
Outcome Measure
Composite of MAE
Outcome Time Frame
30 day post-intervention
Outcome Description
Device success defined as a reduction in tricuspid regurgitation immediately post-intervention
Outcome Measure
Device Success
Outcome Time Frame
immediately post-intervention
Secondary Outcomes
Outcome Description
Change in distance (m) compared to baseline assessment
Outcome Time Frame
30 days, 6 months, annual for five years post-intervention
Outcome Measure
Six minute walk test
Outcome Description
Number of patients presenting with reduction in TR grade compared to baseline assessment
Outcome Time Frame
30 days, 6 months, annual for five years post-intervention
Outcome Measure
Reduction in Tricuspid Regurgitation (TR) Grade
Outcome Description
Number of patients presenting with improvement in NYHA classification
Outcome Time Frame
30 days, 6 months, annual for five years post-intervention
Outcome Measure
New York Heart Association (NYHA) Function Class
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Mohamed Azeem Latib
Investigator Email
mlatib@montefiore.org
Investigator Phone
646-773-2076
Investigator Department
Medicine
Investigator Division
Cardiology
Investigator Sponsor Organization
Montefiore
Study Department
Medicine
Study Division
Cardiology
Categories Mesh Debug
Heart/Cardiovascular --- TRICUSPID VALVE INSUFFICIENCY
Heart/Cardiovascular --- HEART VALVE DISEASES
Blood Disorders --- CARDIOVASCULAR DISEASES
Heart/Cardiovascular --- CARDIOVASCULAR DISEASES
Brain, Spinal Cord & Nervous System --- HEART DISEASES
Heart/Cardiovascular --- HEART DISEASES
MeSH Terms
TRICUSPID VALVE INSUFFICIENCY
HEART VALVE DISEASES
CARDIOVASCULAR DISEASES
HEART DISEASES