Clinical trial NCT03225612: Safety and Performance of the Trialign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS)
Official title: Safety and Performance of the Trialign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) for Symptomatic Chronic Functional Tricuspid Regurgitation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Symptomatic Functional Tricuspid Regurgitation
Tricuspid Valve Insufficiency
Heart Valve Disease
Lead sponsor: Mitralign, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Genae
name: Regulatory and Clinical Research Institute Inc
name: CardioVascular Research Foundation, Korea
First posted: 2017-07-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Chronic functional tricuspid regurgitation (FTR) with a minimum of moderate tricuspid regurgitation;
* ≥18 and ≤85 years old;
* NYHA II, III, or ambulatory IV;
* Symptomatic despite Guideline Directed medical Therapy (GDMT), at minimum, patient on diuretic use;
* patient is at high risk for open heart valve surgery
* LVEF ≥35%
* Tricuspid valve annular diameter ≤55 mm (or 29 mm/m\^2)

Exclusion Criteria:

* Pregnant or lactating female;
* Severe uncontrolled hypertension (SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg);
* Previous tricuspid valve repair or replacement;
* Severe coronary artery disease;
* MI or known unstable angina within the 30-days prior to the index procedure;
* Any PCI within 30 days prior to the index procedure or planned 3 months post the index procedure;
* Chronic oral steroid use (≥6 months);
* Life expectancy of less than 12-months

Primary outcomes:
measure: Incidence of all-cause mortality at 30 days.
timeFrame: 30-days
Secondary outcomes:
measure: Technical success
timeFrame: 30 Days
measure: Echocardiographic variable: tenting height (maximum, any view)
timeFrame: Change from Baseline at 30 days
measure: Echocardiographic variable: tenting area (maximum, any view)
timeFrame: Change from Baseline at 30 days
measure: Echocardiographic variable: Quantification of tricuspid valve and annular area (maximum, any view)
timeFrame: Change from Baseline at 30 days
measure: Tricuspid regurgitation as determined by echocardiographic methods
timeFrame: Change from Baseline at 30 days
measure: Percent tricuspid regurgitation from baseline to 30-days
timeFrame: Change from Baseline at 30 days
measure: Adverse Events
timeFrame: Up to 60 months post procedure
measure: New York Heart Association (NYHA) classification
timeFrame: Change from Baseline at discharge and then 1, 3, 6, 12, 24, 36, 48 and 60 months post procedure
measure: Six-Minute Walk Test (6MWT)
timeFrame: Change from Baseline at discharge and then 1, 3, 6, 12, 24, 36, 48 and 60 months post procedure
measure: Minnesota Living with Heart Failure Questionnaire (MLWHF)
timeFrame: Change from Baseline at discharge and then 1, 3, 6, 12, 24, 36, 48 and 60 months post procedure
measure: EuroQol Five Dimensions Questionnaire (EQ-5D)
timeFrame: Change from Baseline at discharge and then 1, 3, 6, 12, 24, 36, 48 and 60 months post procedure
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Vivantes Klinikum Am Urban
city: Bernau bei Berlin
country: Germany
facility: Herzzentrum Brandenburg in Bernau
city: Frankfurt
country: Germany
facility: CardioVascular Center Frankfurt
city: Hamburg
country: Germany
facility: Medizinisches Versorgungszentrum Prof. Mathey, Prof. Schofer GmbH
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig - Universitätsklinik
city: Munich
country: Germany
facility: German Heart Center Munich
city: Milan
country: Italy
facility: Ospedale San Raffaele
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Porto
country: Portugal
facility: C. Hospitalar Vila Nova de Gaia/Espinho, E.P.E.
Study officials:
affiliation: Medizinisches Versorgungszentrum Prof. Mathey, Prof. Schofer GmbH
name: Prof. Dr. med Joachim Schofer
role: PRINCIPAL_INVESTIGATOR
References: