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This clinical trial aims to evaluate the safety and demonstrate the efficacy of treatment to improve tricuspid regurgitation (TR) symptoms in patients with severe and clinically symptomatic TR through long-term implantation of an investigational medical device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment to Improve TR Symptoms with Investigational Medical Device Implantation | Experimental | Participants assigned to this arm will receive an investigational medical device designed to improve symptoms of severe and clinically symptomatic tricuspid regurgitation (TR). Following device implantation, participants will be monitored in a specialized facility for at least 24 hours with real-time observation of vital signs. The device's safety and efficacy will be assessed over 12 months through scheduled visits, with clinical progress monitored throughout. Device removal may be performed if adverse events occur or if deemed necessary by the investigator. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pivot Extend Tricuspid Regurgitation Spacer Device | Device | The Pivot Extend Tricuspid Regurgitation Spacer Device is an investigational implant designed to reduce tricuspid regurgitation (TR) by occupying the regurgitant orifice and improving leaflet coaptation. The device is implanted via a transcatheter procedure under imaging guidance. Following implantation, participants will undergo post-procedural monitoring for at least 24 hours to ensure safety and device stability. The device is intended for long-term placement, with scheduled follow-up assessments at designated intervals over a 12-month period to evaluate its safety and efficacy. Device removal may be performed if adverse events occur or if deemed necessary by the investigator. |
| Measure | Description | Time Frame |
|---|---|---|
| Major Adverse Cardiac Events(MACEs) | Occurrence Ratio of Major Adverse Cardiac Events (MACEs) | 1 month post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Device Success | The rate of the device successfully placed at target location | during procedure |
| Procedural Success(1) | Changes in TR Grade: The number of the participants who had at least 1 TR grade drop, confirmed through echocardiography |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Markus Reinthaler, MD, PhD | Contact | +49 (0) 157 37972007 | reinthal@gmail.com | |
| Seung-Whan Lee, MD, PhD | Contact | +82 1688-7575 | seungwlee@amc.seoul.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Israeli-Georgian Medical Research Clinic Healthycore | Recruiting | Tbilisi | K'alak'i T'bilisi | 0102 | Georgia |
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| ID | Term |
|---|---|
| D014262 | Tricuspid Valve Insufficiency |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Multi-center, open label, single arm, early feasibility study
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| 1-month, 6-month, 12-month post-procedure |
| Procedural Success(2) | The occurrence rate of MACEs associated with the trial device or procedure | 1-month, 6-month, 12-month post-procedure |
| Clinical Outcomes(1) | Changes in anatomical structure: Changes in right ventricular volume from baseline confirmed through cardiac CT | 6-month, 12-month post-procedure |
| Clinical Outcomes(2) | Changes in NHYA Functional Class: The number of participants whose NYHA functional class improved compared to baseline | 1-month, 6-month, 12-month post-procedure |
| Clinical Outcomes(3) | Changes in Six Minute Walk Test (6MWT): Changes in distance compared to baseline | 1-month, 6-month, 12-month post-procedure |
| Clinical Outcomes(4) | Changes in KCCQ score: Changes in the assessed KCCQ score compared to baseline | 1-month, 6-month, 12-month post-procedure |
| Clinical Outcomes(5) | Changes in edema score: The number of participants who had at least 1 level improvement in edema score compared to baseline | 1-month, 6-month, 12-month post-procedure |
| Clinical Outcomes(6) | Changes in eGFR (estimated glomerular filtration rate): Changes in eGFR compared to baseline | 1-month, 6-month, 12-month post-procedure |
| Tbilisi Heart and Vascular Clinic | Recruiting | Tbilisi | K'alak'i T'bilisi | 0159 | Georgia |
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| Tbilisi Heart Center | Recruiting | Tbilisi | K'alak'i T'bilisi | 0186 | Georgia |
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