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| General |
| Study Status |
Study Pending |
Application Number /
Requirement Number |
P230007 / PAS002 |
| Date Original Protocol Accepted |
05/31/2024
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| Date Current Protocol Accepted |
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| Study Name |
Registry-Based Real-World Use Surveillance
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| Device Name |
TriClip G4 System
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| Clinical Trial Number(s) |
NCT03904147
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| General Study Protocol Parameters |
| Study Design |
Comprehensive/Linked/RegistryBased Surveillance
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| Data Source |
External Registry
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| Comparison Group |
No Control
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| Analysis Type |
Descriptive
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| Study Population |
Transit. Adolescent A (distinctively) : 18-21 yrs,
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
Design: This is a prospective, single-arm, observational, multi-center, post-approval study. Patients in the TriClip PAS will be treated and followed per the hospital standard of care.
Objective: The objective of the TriClip PAS is to assess the real-world performance of the TriClip™ System in a contemporary real-world setting as well as to assess clinical outcomes of the device in patient populations underrepresented in the TRILUMINATE Pivotal trial
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| Study Population |
All consecutive patients who are at least 18 years old from the general population who undergo an attempted TriClip procedure and are entered into the TVT Registry
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| Sample Size |
Number of subjects: This study will involve all consecutive patients treated within the first 2 years following the approval of TriClip™ System or a total of 5,000 consecutively treated patients, whichever is greater, who are entered into the TVT Registry. Additionally, this study will enroll a minimum of 100 patients from each of the following racial and ethnic groups (Black/African American, Asian, American Indian/Alaskan Native, Native Hawaiian/Pacific Islander, and Hispanic or Latino ethnicity). If required, enrollment will continue in these racial and ethnic groups (past the 5,000 consecutive patients) until the specific enrollment is met.
Assumptions for sample size estimation: N/A
Number of sites: A minimum of 50 US commercial sites participating in the TVT registry.
Sites location: US commercial sites. Additionally, A representative subset of sites will be selected based on procedural volume/implanter experience and geographical location in order to evaluate outcomes in a cohort of patients that is not overrepresented by a specific type of site. Additionally, at least 50% of the sites included in this representative group will not have participated in the TRILUMINATE Pivotal trial.
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| Key Study Endpoints |
The following endpoints will be collected from the first implant procedure via the TVT Registry Tricuspid Valve Data Collection Form:
• All-cause mortality through 1 year
• Stroke through 1 year
• Hospitalizations through 1 year
• Heart failure hospitalizations through 1 year (pending addition to the data collection form)
• Tricuspid valve (TV) re-intervention through 1 year
• Adverse events (AE) through 1 year
• TR grade at baseline, discharge, 30 days, and 1 year
• NYHA Class at baseline, 30 days, and 1 year
• KCCQ-12 score at baseline, 30 days, and 1 year
• Six-Minute Walk Test (6MWT) at baseline, 30 days, and 1 year
The following endpoints will be reported from 2 years through 5 years post-procedure annually via linking the TVT Registry data with the CMS claims database:
• All-cause mortality
• Stroke
• Hospitalizations
• Heart failure hospitalizations
• TV reintervention
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| Follow-up Visits and Length of Follow-up |
Clinical assessment and echocardiographic data at baseline, procedure, discharge, 30 days post-procedure, and 1-year post-procedure will be captured through the TVT Registry Tricuspid Valve Data Collection Form. Long-term endpoints from 2 years through 5 years post-procedure will be reported annually by linking the TVT Registry data with the CMS claims database.
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