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| Name | Class |
|---|---|
| Genae | INDUSTRY |
| Regulatory and Clinical Research Institute Inc | OTHER |
| CardioVascular Research Foundation, Korea | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open Label | Experimental | Non-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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of all-cause mortality at 30 days. | Incidence of all-cause mortality at 30 days. | 30-days |
| Measure | Description | Time Frame |
|---|---|---|
| Technical success | Technical success, defined as freedom from death at 30 days with:
| 30 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patricia Keating | Contact | 978-863-2445 | pkeating@mitralign.com | |
| Gisella Blanchette | Contact | 978.863.2435 | gblanchette@mitralign.com |
| Name | Affiliation | Role |
|---|---|---|
| Prof. Dr. med Joachim Schofer | Medizinisches Versorgungszentrum Prof. Mathey, Prof. Schofer GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vivantes Klinikum Am Urban | Recruiting | Berlin | 10967 | Germany |
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|
| 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 | 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 | 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 | Change from Baseline at 30 days |
| Tricuspid regurgitation as determined by echocardiographic methods | As measured by the PISA method and the Quantitative Flow method | Change from Baseline at 30 days |
| Percent tricuspid regurgitation from baseline to 30-days | Percent tricuspid regurgitation from baseline to 30-days | Change from Baseline at 30 days |
| Adverse Events | Rate of adverse events, including serious adverse events | Up to 60 months post procedure |
| New York Heart Association (NYHA) classification | Change in New York Heart Association (NYHA) classification | 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) | 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) | 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) | Change from Baseline at discharge and then 1, 3, 6, 12, 24, 36, 48 and 60 months post procedure |
| Herzzentrum Brandenburg in Bernau | Recruiting | Bernau bei Berlin | 16321 | Germany |
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| CardioVascular Center Frankfurt | Recruiting | Frankfurt | 60389 | Germany |
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| Medizinisches Versorgungszentrum Prof. Mathey, Prof. Schofer GmbH | Recruiting | Hamburg | 22527 | Germany |
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| Herzzentrum Leipzig - Universitätsklinik | Recruiting | Leipzig | 04289 | Germany |
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| German Heart Center Munich | Recruiting | Munich | 80636 | Germany |
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| Ospedale San Raffaele | Recruiting | Milan | 20132 | Italy |
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| Azienda Ospedaliero Universitaria Pisana | Recruiting | Pisa | 56126 | Italy |
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| Amphia Ziekenhuis | Not yet recruiting | Breda | 4818 CK | Netherlands |
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| University Medical Center Groningen | Recruiting | Groningen | 9713 GZ | Netherlands |
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| C. Hospitalar Vila Nova de Gaia/Espinho, E.P.E. | Recruiting | Porto | Portugal |
|
| ID | Term |
|---|---|
| D014262 | Tricuspid Valve Insufficiency |
| D006349 | Heart Valve Diseases |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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