Congenital Heart Disease, Pulmonary Disease, Pulmonary Regurgitation, Tetralogy of Fallot, Transcatheter Pulmonary Valve Replacement (TPVR)
Conditions
Brief summary
To demonstrate the safety and effectiveness of the Edwards Alterra Adaptive Prestent in conjunction with the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) System in subjects with a dysfunctional right ventricular outflow tract/pulmonary valve (RVOT/PV) who are indicated for treatment of pulmonary regurgitation (PR). Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.
Interventions
DEVICEEdwards Alterra Adaptive Prestent with SAPIEN 3 THV
The Edwards Alterra Adaptive Prestent is designed to reduce the diameter of large irregular RVOTs and provide a circular, semi-rigid landing zone to place an Edwards SAPIEN 3 THV.
Sponsors
Edwards Lifesciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single arm, prospective, multi-center study
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. The candidate/candidate's legally authorized representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent. 2. Weight is ≥ 20 kg (44 lbs). 3. RVOT/PV with moderate or greater PR by TTE. 4. RVOT/PV proximal and distal landing zone diameter ≥ 27 mm and ≤ 38 mm, and minimum of 35 mm from contractile tissue to lowest pulmonary artery takeoff.
Exclusion criteria
1. Active infection requiring current antibiotic therapy (if temporary illness, patient may be a candidate 2 weeks after discontinuation of antibiotics). 2. History of or active endocarditis (active treatment with antibiotics) within the past 180 days. 3. Leukopenia (WBC \< 2000 cells/μL), anemia (Hgb \< 7 g/dL), thrombocytopenia (platelets \< 50,000 cells/μL) or any known blood clotting disorder. 4. Inappropriate anatomy for introduction and delivery of the Alterra Adaptive Prestent or the SAPIEN 3 THV. 5. Need for concomitant atrial septal defect or ventricular septal defect closure or other concomitant interventional procedures other than pulmonary artery or branch pulmonary artery stenting or angioplasty 6. Interventional/surgical procedures within 30 days prior to the Alterra or valve implant procedure 7. Any planned surgical, percutaneous coronary or peripheral procedure to be performed within the 30 day follow-up from the Alterra or valve implant procedure 8. History of or current intravenous drug use 9. Major or progressive non-cardiac disease resulting in a life expectancy of less than one year 10. Known hypersensitivity to aspirin or heparin and cannot be treated with other antiplatelet and/or antithrombotic medications 11. Known hypersensitivity to nitinol, cobalt-chromium, nickel or contrast media that cannot be adequately pre-medicated 12. Currently participating in an investigational drug or another device study \[Note: Trials requiring extended follow up for products that were investigational, but have since become commercially available, are not considered investigational devices.\] 13. Positive urine or serum pregnancy test in female patients of child-bearing potential 14. Renal insufficiency (creatinine \> 3.0 mg/dL) and/or renal replacement therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Main Cohort: THV Dysfunction | 6 months | Number of patients with THV dysfunction, defined as a non-hierarchical composite of: * RVOT/PV Reintervention * Moderate or greater total Pulmonic Regurgitation via Transthoracic Echocardiography (TTE) * Mean RVOT/PV Gradient \>= 35mmHg via TTE |
| PDS Registry: Acute PDS Success | 24 hours | Number of patients with acute PDS success, defined as a non-hierarchical composite of: * Single THV implanted in the desired location * Right ventricle to pulmonary artery (RV-PA) peak-to-peak gradient \< 35 mmHg post-THV implantation * Less than moderate total pulmonary regurgitation by discharge TTE (or earliest evaluable TTE) * Free of SAPIEN 3 / Alterra explant at 24 hours post-implantation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Main Cohort: Improvement in Total Pulmonary Regurgitation From Baseline | 30 days | Number of patients with improvement in total pulmonary regurgitation |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TPVR - Main Cohort Implantation of Edwards Alterra Adaptive Prestent and Edwards SAPIEN 3 THV using Commander Delivery System.
Edwards Alterra Adaptive Prestent with SAPIEN 3 THV: The Edwards Alterra Adaptive Prestent is designed to reduce the diameter of large irregular RVOTs and provide a circular, semi-rigid landing zone to place an Edwards SAPIEN 3 THV. | 61 |
| TPVR - PDS Registry Implantation of Edwards Alterra Adaptive Prestent and Edwards SAPIEN 3 THV using Pulmonic Delivery System (PDS).
Edwards Alterra Adaptive Prestent with SAPIEN 3 THV: The Edwards Alterra Adaptive Prestent is designed to reduce the diameter of large irregular RVOTs and provide a circular, semi-rigid landing zone to place an Edwards SAPIEN 3 THV. | 25 |
| Total | 86 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
| Overall Study | Did not meet eligibility criteria | 1 | 0 |
Baseline characteristics
| Characteristic | TPVR - Main Cohort | TPVR - PDS Registry | Total |
|---|---|---|---|
| Age, Continuous | 29.5 years STANDARD_DEVIATION 16.44 | 29.1 years STANDARD_DEVIATION 17.23 | 29.4 years STANDARD_DEVIATION 16.57 |
| Race/Ethnicity, Customized Race Asian | 5 Participants | 3 Participants | 8 Participants |
| Race/Ethnicity, Customized Race Black or African American | 7 Participants | 4 Participants | 11 Participants |
| Race/Ethnicity, Customized Race Hispanic or Latino | 3 Participants | 2 Participants | 5 Participants |
| Race/Ethnicity, Customized Race Multiple Races | 2 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized Race Unknown | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Race White | 43 Participants | 13 Participants | 56 Participants |
| Sex: Female, Male Female | 27 Participants | 11 Participants | 38 Participants |
| Sex: Female, Male Male | 34 Participants | 14 Participants | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 61 | 1 / 25 |
| other Total, other adverse events | 35 / 61 | 11 / 25 |
| serious Total, serious adverse events | 8 / 61 | 5 / 25 |
Outcome results
Primary
Main Cohort: THV Dysfunction
Number of patients with THV dysfunction, defined as a non-hierarchical composite of: * RVOT/PV Reintervention * Moderate or greater total Pulmonic Regurgitation via Transthoracic Echocardiography (TTE) * Mean RVOT/PV Gradient \>= 35mmHg via TTE
Time frame: 6 months
Population: Valve implant population, 1 subject did not complete the 6 month follow up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TPVR - Main Cohort | Main Cohort: THV Dysfunction | 0 Participants |
Primary
PDS Registry: Acute PDS Success
Number of patients with acute PDS success, defined as a non-hierarchical composite of: * Single THV implanted in the desired location * Right ventricle to pulmonary artery (RV-PA) peak-to-peak gradient \< 35 mmHg post-THV implantation * Less than moderate total pulmonary regurgitation by discharge TTE (or earliest evaluable TTE) * Free of SAPIEN 3 / Alterra explant at 24 hours post-implantation
Time frame: 24 hours
Population: Attempted implant population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TPVR - Main Cohort | PDS Registry: Acute PDS Success | 22 Participants |
Secondary
Main Cohort: Improvement in Total Pulmonary Regurgitation From Baseline
Number of patients with improvement in total pulmonary regurgitation
Time frame: 30 days
Population: Valve implant population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TPVR - Main Cohort | Main Cohort: Improvement in Total Pulmonary Regurgitation From Baseline | 60 Participants |