To assess the safety and performance of the Trialign System for the treatment of symptomatic chronic functional tricuspid regurgitation in patients with a minimum of moderate tricuspid regurgitation.
ID
Source
Brief title
Condition
- Cardiac valve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Endpoint: Incidence of all-cause mortality at 30 days.
Secondary outcome
Technical success, defined as freedom from death at 30 days with;
1) successful access, delivery and retrieval of the device delivery system;
2) deployment and correct positioning of the intended device(s) which is
maintained and;
3) no need for additional unplanned or emergency surgery or re-intervention
related to the device or access procedure
Echocardiographic variables assessed by the Echocardiographic Core Lab at
baseline and 30-days reflecting the severity of tricuspid pathology and the
response to the Trialign device:
1) Native Tricuspid valve morphology:
*- Tenting Height (maximum, any view)
*- Tenting Area (maximum, any view)
*- Quantification of tricuspid valve and annular area
2) Tricuspid regurgitation as determined by echocardiographic methods at
baseline and 30 days.
- PISA (Proximal Isovelocity Surface Area) method
- Quantitative flow method
3) Percent tricuspid regurgitation from baseline to 30-days
Rate of adverse events, including serious adverse events
Clinical Status Endpoints:
1) New York Heart Association (NYHA) classification
2) Six-minute walk test (6MWT)
3) Minnesota Living with Heart Failure Questionnaire (MLWHF)
4) EuroQol five dimensions questionnaire (EQ-5D)
Change from baseline in clinical status endpoints and echocardiographic
variables assessed by the Echocardiographic Core Lab will be measured at
discharge, 1, 3, 6, 12, 24, 36, 48 and 60 months post procedure.
Background summary
Tricuspid Regurgitation (TR) is an important disease in which the efficiency of
the right ventricle is reduces, leading to several symptoms such as: fatigue,
anorexia, elevated jugular venous pressure, hepatomegaly, ascites, peripheral
edema, skin ulcerations, dilation of the right atrium, kidney disease and
chronic atrial fibrillation. These symptoms reduce the quality of life of the
patients.
Tricuspid regurgitation often exists in a setting of left ventricular
dysfunction and associated mitral valve disease.
The current treatment is often surgical repair of the tricuspid valve, however
this is only recommended to patients who also have mitral valve disease
requiring surgical treatment. So patients suffering from TR, but that are not
yetsevere enough to have surgical treatment of the mitral valve, often are not
eligible for the current treatment of surgical repair or replacement.
Therefore there is a large unmet need to new procedures and medical devices for
minimal invasie repair of the tricuspid valve, so that these patients can be
treated and hopefully their quality of life can be improved.
The study is designed to assess the safety and performance of the Trialign
System for the treatment of symptomatic chronic functional tricuspid
regurgitation in patients with a minimum of moderate tricuspid regurgitation
Study objective
To assess the safety and performance of the Trialign System for the treatment
of symptomatic chronic functional tricuspid regurgitation in patients with a
minimum of moderate tricuspid regurgitation.
Study design
Prospective, single-arm, multi-center study (not randomised, not blinded) in up
to 60 patients in up to 15 sites in Europe and US.
Intervention
Trialign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS)
Trialign PTVAS System is designed to perform a percutaneous suture annuloplasty
of the tricuspid annulus to treat chronic functional tricuspid
regurgitation. The Trialign PTVAS procedure utilizes catheters and wires to
deliver up to two sets of -pledgeted sutures across the tricuspid annulus near
the septal/posterior and the posterior/anterior commissures. Each set of
implants is pulled together to plicate the posterior tricuspid annulus.
The system will be delivered percutaneously via the right internal jugular
vein. The procedure will be guided by fluoroscopy and trans-esophageal
echocardiography.
The Trialign PTVAS System is intended for the treatment of symptomatic chronic
functional tricuspid regurgitation in patients with moderate to severe
tricuspid regurgitation.
Study burden and risks
In-vitro, in-vivo, and biocompatibiltiy testing has identified and mitigated
all known possible risks. The overall outcome of animal studies confirmed that
placement of the Trialign device was feasible, safe and achieved its intended
effect: reduction in annular diameter. Finally,
early experience in in the FDA early feasibility study and the Special Access
patient experiences has demonstrated safety and feasibility of the Trialign
device. The SCOUT II is now designed to assess the safety and performance of
the Trialign PTVAS in a larger patient population. Based on all the evidence
assembled to date, we believe that the potential benefit of participation in
the SCOUT II Study clearly outweighs the potential risks.
Highwood Drive 3
Tewksbury MA 01876
US
Highwood Drive 3
Tewksbury MA 01876
US
Listed location countries
Age
Inclusion criteria
1. >=18 and <=85 years old
2. New York Heart Association (NYHA) Class II, III or ambulatory IV
3. Symptomatic despite Guideline Directed Medical Therapy (GDMT) for at least 1 month; including diuretics
4. The patient is at high risk for open heart valve surgery
5. The heart team recommends tricuspid annuloplasty, in accordance with the recommendations of the 2012 ESC Valve Guidelines
6. Patient or legal guardian understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed
7. Patient is willing and able to comply with all specified study evaluations
Exclusion criteria
1. History of heart transplant
2. Severe uncontrolled hypertension (SBP >= 180 mmHg and/or DBP >= 110 mmHg)
3. Previous tricuspid valve repair or replacement (including artificial valve)
4. Presence of LVAD, trans-tricuspid pacemaker or defibrillator leads
5. Active endocarditis
6. Severe coronary artery disease
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 |
|---|---|
| CCMO | NL60930.042.17 |