The purpose of this study is to assess the safety and performance of the Trialign System for the treatment of symptomatic chronic functional tricuspid regurgitation (FTR) in patients with a minimum of moderate tricuspid regurgitation. The procedure will be performed with the PTVAS device using a non-surgical percutaneous approach to tricuspid valve repair in patients who have FTR with a minimum of moderate tricuspid regurgitation.
A prospective, single-arm, multi-center study, enrolling symptomatic patients with chronic functional tricuspid regurgitation. The study will include up to 60 subjects from up to 15 sites in Europe and the United States. Follow-up evaluations will be conducted through 5 years post implantation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) is delivered by a percutaneous transcatheter procedure. 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.
Vivantes Klinikum Am Urban
Berlin, Germany
RECRUITINGHerzzentrum Brandenburg in Bernau
Bernau bei Berlin, Germany
RECRUITINGCardioVascular Center Frankfurt
Frankfurt, Germany
RECRUITINGMedizinisches Versorgungszentrum Prof. Mathey, Prof. Schofer GmbH
Hamburg, Germany
RECRUITINGHerzzentrum Leipzig - Universitätsklinik
Leipzig, Germany
RECRUITINGGerman Heart Center Munich
Munich, Germany
RECRUITINGOspedale San Raffaele
Milan, Italy
RECRUITINGAzienda Ospedaliero Universitaria Pisana
Pisa, Italy
RECRUITINGAmphia Ziekenhuis
Breda, Netherlands
NOT_YET_RECRUITINGUniversity Medical Center Groningen
Groningen, Netherlands
RECRUITING...and 1 more locations
Incidence of all-cause mortality at 30 days.
Incidence of all-cause mortality at 30 days.
Time frame: 30-days
Technical success
Technical success, defined as freedom from death at 30 days with: * successful access, delivery and retrieval of the device delivery system; * deployment and correct positioning of the intended device(s) which is maintained and; * no need for additional unplanned or emergency surgery or re-intervention related to the device or access procedure
Time frame: 30 Days
Echocardiographic variable: tenting height (maximum, any view)
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
Time frame: Change from Baseline at 30 days
Echocardiographic variable: tenting area (maximum, any view)
Echocardiographic variable assessed by the Echocardiographic Core Lab at baseline and 30-days reflecting the severity of tricuspid pathology and the response to the Trialign device
Time frame: Change from Baseline at 30 days
Echocardiographic variable: Quantification of tricuspid valve and annular area (maximum, any view)
Echocardiographic variable assessed by the Echocardiographic Core Lab at baseline and 30-days reflecting the severity of tricuspid pathology and the response to the Trialign device
Time frame: Change from Baseline at 30 days
Tricuspid regurgitation as determined by echocardiographic methods
As measured by the PISA method and the Quantitative Flow method
Time frame: Change from Baseline at 30 days
Percent tricuspid regurgitation from baseline to 30-days
Percent tricuspid regurgitation from baseline to 30-days
Time frame: Change from Baseline at 30 days
Adverse Events
Rate of adverse events, including serious adverse events
Time frame: Up to 60 months post procedure
New York Heart Association (NYHA) classification
Change in New York Heart Association (NYHA) classification
Time frame: Change from Baseline at discharge and then 1, 3, 6, 12, 24, 36, 48 and 60 months post procedure
Six-Minute Walk Test (6MWT)
Change in the Six-Minute Walk Test (6MWT)
Time frame: Change from Baseline at discharge and then 1, 3, 6, 12, 24, 36, 48 and 60 months post procedure
Minnesota Living with Heart Failure Questionnaire (MLWHF)
Score on the Minnesota Living with Heart Failure Questionnaire (MLWHF)
Time frame: Change from Baseline at discharge and then 1, 3, 6, 12, 24, 36, 48 and 60 months post procedure
EuroQol Five Dimensions Questionnaire (EQ-5D)
Score on the EuroQol Five Dimensions Questionnaire (EQ-5D)
Time frame: Change from Baseline at discharge and then 1, 3, 6, 12, 24, 36, 48 and 60 months post procedure
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