To confirm the safety and performance of the TriClip* Tricuspid Valve Repair System in a real-world setting.
ID
Source
Brief title
Condition
- Cardiac valve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is Acute Procedural Success (APS) defined as successful
implantation of the TriClip* device with resulting TR reduction at least 1
grade at discharge (30-day echocardiogram will be used if discharge is
unavailable or uninterpretable). Subjects who die or undergo tricuspid valve
surgery before discharge are considered to be an APS failure.
Secondary outcome
Secundary endpoint:
The secondary endpoint is a composite endpoint of all-cause mortality or
tricuspid valve re-intervention/re-operation at 1 year.
Clinical Endpoints:
Assessed at discharge, 30-days, 1 year and annually through 5 years (unless
indicated)
• Major Adverse Event (MAE) - MAE defined as a composite of cardiovascular
mortality, myocardial infarction, stroke, new onset renal failure, endocarditis
requiring surgery, and non-elective CV surgery for TriClip* device-related AE
post-procedure
• Device Related Adverse Events (including Tricuspid valve stenosis, device
embolization, Single Leaflet Device Attachment (SLDA), Myocardial perforation,
or the need for Tricuspid valve replacement instead of repair due at least in
part to the TriClip* procedure or the presence of the TriClip* device)
• All-cause mortality
• TR grade, including change from baseline
• Number and duration of re-hospitalizations and reason for re-hospitalization
(i.e., heart failure, cardiovascular, non-cardiovascular)
• NYHA Functional Class improvement, Kansas City Cardiomyopathy questionnaire
• Composite of tricuspid valve re-intervention/re-operation or worsening of TR
• Composite of all-cause mortality or tricuspid valve
re-intervention/re-operation
Background summary
TR, or tricuspid valve insufficiency, is a failure of the tricuspid valve (TV)
to close completely during systole resulting in leakage or *regurgitation* of
blood from the right ventricle (RV) to the right atrium with each contraction
of the RV. Symptoms associated with TR, are generally those of right-sided
heart failure, include ascites, peripheral edema, hepatomegaly, decreased
appetite, jugular vein enlargement and/or abdominal fullness. Additionally, TR
severity is associated with worse survival regardless of LVEF or pulmonary
artery pressure.TR has long been an overlooked condition.
Current treatment guidelines for TR indicate medical therapy to address venous
congestion (e.g., diuretics) and/or treatment of the underlying disease to
reduce TR (e.g., surgery)
The *Trial to Evaluate Treatment with Abbott Transcatheter Clip Repair System
in Patients with Moderate or Greater Tricuspid Regurgitation (TRILUMINATE)* was
initiated to investigate the safety and performance of the Tricuspid Valve
Repair System (TVRS; also known as TriClip*). Six-month outcomes from the
TRILUMINATE study were recently published in Lancet1. Both the primary safety
and performance endpoints of the clinical study were successfully met.
Tricuspid regurgitation (TR) was successfully reduced in 85.5% of the subjects
who had available echocardiogram data and imaging at 30 day. At 6 months, only
five (6.0%) subjects experienced a major adverse event (MAE). Furthermore,
subjects treated with the TriClip* device also experienced a significant
improvement in quality of life and functional capacity1.
The TriClip* bRIGHT EU post-approval study (PAS) study is designed to confirm
the safety and performance of the TriClip* device in a contemporary real-world
setting.
Study objective
To confirm the safety and performance of the TriClip* Tricuspid Valve Repair
System in a real-world setting.
Study design
The bRIGHT PAS study is a prospective, single arm, open-label, multi-center,
post market registry, conducted to satisfy condition of CE Marking for the
TriClip* TVRS.
Study burden and risks
The study follows the standard care and additional TTE's are made and blood
withdrawals are performed specifically for the study. The additional risks are
considered minimal.
Standaardruiter 13
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Standaardruiter 13
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Listed location countries
Age
Inclusion criteria
1. Subjects (>=18 years age) have severe tricuspid regurgitation and are
symptomatic despite
medical therapy.
2. Subjects eligible to receive the TriClip* per the current approved intended
use and target patient
population.
3. Subject must provide written informed consent prior to study procedure.
Exclusion criteria
1. Subjects participating in another clinical study that may impact the
follow-up or results of this
study.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT04483089 |
| CCMO | NL74504.100.20 |