Safety and Performance of the Trialign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS)
SCOUT-II
1 other identifier
interventional
60
4 countries
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2017
Longer than P75 for not_applicable
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 22, 2017
CompletedFirst Submitted
Initial submission to the registry
June 14, 2017
CompletedFirst Posted
Study publicly available on registry
July 21, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2022
CompletedFebruary 7, 2018
February 1, 2018
1 year
June 14, 2017
February 6, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of all-cause mortality at 30 days.
Incidence of all-cause mortality at 30 days.
30-days
Secondary Outcomes (11)
Technical success
30 Days
Echocardiographic variable: tenting height (maximum, any view)
Change from Baseline at 30 days
Echocardiographic variable: tenting area (maximum, any view)
Change from Baseline at 30 days
Echocardiographic variable: Quantification of tricuspid valve and annular area (maximum, any view)
Change from Baseline at 30 days
Tricuspid regurgitation as determined by echocardiographic methods
Change from Baseline at 30 days
- +6 more secondary outcomes
Study Arms (1)
Open Label
EXPERIMENTALNon-randomized, open label clinical study that intends to treat up to 60 subjects with the Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) using standard of care techniques and services that are typically used for structural heart procedures.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mitralign, Inc.lead
- Genaecollaborator
- Regulatory and Clinical Research Institute Inccollaborator
- CardioVascular Research Foundation, Koreacollaborator
Study Sites (11)
Vivantes Klinikum Am Urban
Berlin, 10967, Germany
Herzzentrum Brandenburg in Bernau
Bernau bei Berlin, 16321, Germany
CardioVascular Center Frankfurt
Frankfurt, 60389, Germany
Medizinisches Versorgungszentrum Prof. Mathey, Prof. Schofer GmbH
Hamburg, 22527, Germany
Herzzentrum Leipzig - Universitätsklinik
Leipzig, 04289, Germany
German Heart Center Munich
Munich, 80636, Germany
Ospedale San Raffaele
Milan, 20132, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, 56126, Italy
Amphia Ziekenhuis
Breda, 4818 CK, Netherlands
University Medical Center Groningen
Groningen, 9713 GZ, Netherlands
C. Hospitalar Vila Nova de Gaia/Espinho, E.P.E.
Porto, Portugal
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Prof. Dr. med Joachim Schofer
Medizinisches Versorgungszentrum Prof. Mathey, Prof. Schofer GmbH
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 14, 2017
First Posted
July 21, 2017
Study Start
May 22, 2017
Primary Completion
June 1, 2018
Study Completion
November 1, 2022
Last Updated
February 7, 2018
Record last verified: 2018-02