TRICUS STUDY - Safety and Efficacy of the TricValve® Device
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03723239|
Recruitment Status : Active, not recruiting
First Posted : October 29, 2018
Last Update Posted : February 2, 2021
|Condition or disease||Intervention/treatment||Phase|
|Severe Tricuspid Regurgitation||Device: TricValve® System||Not Applicable|
TricValve® Transcatheter Bicaval Valves is a system of two self-expanding biological valves for the treatment of patients with hemodynamically relevant tricuspid insufficiency and caval reflux. The prostheses are implanted percutaneously into the inferior and superior vena cava without disturbing the native tricuspid valve. It is especially intended for use for patients at extreme risk or who are inoperable for open surgical therapy.
Pre-Clinical and Clinical preliminary studies have shown an acceptable safety and performance profile of the TricValve® Transcatheter Bicaval Valves System. Given that the medical device is a potential long-term treatment for patients with tricuspid insufficiency, clinical data for long-term treatment periods is necessary. Thus, the current study is designed to investigate the safety and performance for at least 30 days and up to 5 years.
The study has been approved by the Kaunas Regional Biomedical Research Ethics Committee.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||TRICUS STUDY - Safety and Efficacy of the TricValve® Transcatheter Bicaval Valves System in the Superior and Inferior Vena Cava in Patients With Severe Tricuspid Regurgitation.|
|Actual Study Start Date :||September 12, 2018|
|Estimated Primary Completion Date :||July 2021|
|Estimated Study Completion Date :||July 2026|
Experimental: TricValve® System Single-Arm
Minimally invasive catheter-supported, bicaval tricuspid valve (self-expanding) replacement
Device: TricValve® System
The TricValve® Delivery System is inserted from the femoral vein to access the inferior vena cava (IVC) and superior vena cava (SVC) of the heart under fluoroscopy guidance. The appropriately sized TricValve® is unsheathed at the implantation site and positions itself as per the anatomy - self expanding frame.
- Percentage of participants with major adverse events [ Time Frame: 30 days ]The percentage of participants with major adverse events (death, myocardial infarction, cardiac tamponade, cardiac surgery for failed TricValve® implantation, stroke. Major bleeding according to Valve Academic Research Consortium (VARC) criteria)
- Change of New York Heart Association (NYHA) functional class [ Time Frame: 6 months ]Change of New York Heart Association (NYHA) functional class from III or IV to a lower one
- Successful implantation [ Time Frame: Up to Discharge (≤ 10 days post index procedure) ]The percentage of surviving participants with successful access, delivery and retrieval of the device delivery system, and deployment and correct positioning of the intended device(s), and no need for additional unplanned or emergency surgery or re-intervention related to the device or access procedure.
- Unrestricted movement of cusps [ Time Frame: Up to 30 days, up to 6 months, up to 5 years ]The percentage of medical devices with unrestricted movement of cusps after implantation as assessed with echocardiography (nominal)
- Cusp insufficiency [ Time Frame: Up to 30 days, up to 6 months, up to 5 years ]The change of the degree of cusp insufficiency as assessed with echocardiography (ordinal) from a higher to a lower value
- Device success [ Time Frame: Up to 30 days, up to 6 months, up to 5 years ]Device success as measured by number of patients who are alive with intended device in place with no additional surgical or interventional procedures related to the TricValve®.
- NYHA functional class [ Time Frame: Up to 30 days, up to 5 years ]Number of Patients with improvement of NYHA functional class
- 6 Minute Walk Test [ Time Frame: Up to 30 days, up to 6 months, up to 5 years ]Improvement in distance (m) in the 6 Minute Walk Test
- Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: Up to 30 days, up to 6 months, up to 5 years ]Number of Patients with improvement in quality of life as assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ, a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Range of 0-100, in which higher scores reflect better health status.)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03723239
|LSMUH Kauno Kliniko|
|Principal Investigator:||Alexander Lauten, Prof.Dr.med.||Charite University, Berlin, Germany|
|Principal Investigator:||Rimantas Benetis, Prof.||Hospital of Lithuanian University of Health Sciences Kauno Klinikos|