functional tricuspid regurgitation (TR)
Conditions
Interventions
The enrolled patient will undergo 2 interventions.
1) The index implant procedure. The initial percutane transkatheter
implantation of the Cardiac Implants DaVingi* TR annuloplastyring.
2) The index
Sponsors
Cardiac Implants LLC.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Moderate to Severe functional tricuspid regurgitation (FTR) as defined by ASE2. 2. Symptoms of right ventricular (RV) failure despite guideline directed medical therapy, NYHA Class II-IV. 3. Multidisciplinary heart team (minimum of three physicians, including Imaging and heart Failure cardiologists and cardiac surgery representatives) agree that percutaneous tricuspid annuloplasty is a reasonable treatment option and consider the subject to be a high risk for surgical annuloplasty. 4. >=18 years old at time of enrollment. 5. LVEF >= 30% within 45 days prior to index implant procedure. 6. PASP = 13 mm within 45 days prior to index implant procedure. 8. Tricuspid valve annular diameter >= 40 mm as measured by baseline TTE in the 4 chamber view within 45 days prior to index implant procedure. 9. Subject has provided written informed consent. 10. Subject agrees to comply with all required post-procedure follow-up visits, including device adjustment.
Exclusion criteria
Exclusion criteria: 1. Acutely decompensated heart failure (i.e. hemodynamically unstable or on IV inotropes). 2. Severe RV dysfunction per ASE guidelines3. 3. Primary tricuspid pathology (e.g. rheumatic, congenital, infective, etc.). 4. Previous tricuspid valve repair or replacement. 5. Transvalvular pacemaker or defibrillator lead is present. 6. Severe left-sided valve disease. 7. Right-sided intra-cardiac mass, thrombus or vegetation is present. 8. Inability to properly guide the index implant procedure using TEE (e.g. acoustic window not adequate). 9. MI or known unstable angina within the 30-days prior to the implant index procedure. 10. CVA within 3 months prior to index implant procedure. 11. Bleeding disorders, active peptic ulcer or GI bleed. 12. Contraindication to anticoagulation or antiplatelet medication, based on investigator*s opinion. 13. Chronic oral steroid or immunomodulator use (>= 6 months) or other condition that could impair healing response (e.g. cardiac sarcoidosis or other chronic inflammatory disease). 14. Any condition that, in the opinion of the investigator, may render the subject unable to complete the study (life expectancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety endpoints - Implant Device SADE: the incidence and severity of device-related serious adverse device effects (SADE) from time of index implant procedure through 30 days post-implant. - Adjustment Device SADE: the incidence and severity of device-related serious adverse device effects (SADE) from time of index adjustment procedure through 30 days post-adjustment. Performance Endpoints - Implant Device Technical Success: Rate of successful delivery, deployment and implantation of a DaVingi* TR ring onto the tricuspid annulus, defined as (a) number of stakes embedded in tissue at the end of the procedure (by fluoroscopic and/or echocardiographic assessment) (b) the ring is in stable position on the atrial side of the tricuspid valve as evidence by post-procedure cine CT showing concordant motion of the stakes with the plane of the tricuspid annulus. Note: Implant Device Technical Success shall be assessed at the time of the index procedure after all DaVingi* TR ring devices have been used at the annulus - Adjustment Device Technical Success: Rate of successful adjustment of the DaVingi* TR ring at the tricuspid annulus (i.e., level of annular contraction desired by physician is achieved). The co-primary performance endpoint will also be reported for each individual component of the endpoint. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety Endpoints • Incidence of device-related major adverse cardiac events (MACE)5 through 30 days post-implant and through 365 days post-index adjustment procedure. • Rate of procedure-related serious adverse events (SAE) through 30 days post-implant and through 365 days-post index adjustment procedure. Performance Endpoints • Implant Procedural Success: Implant Device Technical Success met and no SADE(s) within 24 hours post index implant procedure. • Adjustment Procedural Success: Adjustment Device Technical Success met and no SADE(s) within 24 hours post index adjustment procedure. • Ability to maintain improvement in TR: at 30, 90, 180- and 365-days post-index adjustment procedure, relative to baseline. • Change in Quality of Life assessment: by KCCQ at 90, 180- and 365-days years post-index adjustment procedure, relative to baseline. • Change in 6MWT: at 90, 180, and 365 days post-index adjustment procedure, relative to baseline. • Number of heart failure hospitalizations: through 365 days post-index adjustment procedure, as compared to 365-day interval prior to enrollment. • The need for re-intervention for TR: at 30, 90, 180- and 365-days post-index adjustment procedure. • Changes in NYHA Class: at 30, 90, 180- and 365-days post-index adjustment procedure, relative to baseline. | — |
Countries
Netherlands
Outcome results
None listed