Dysfunctional RVOT Conduit, Pulmonary Obstruction, Pulmonary Regurgitation, Pulmonary Stenosis, Pulmonary Valve Insufficiency
Conditions
Keywords
Pulmonic, Regurgitation, Pulmonary Valve Conduit, Stenosis, Congenital Heart Defect
Brief summary
To assess the safety and effectiveness of pulmonic THV implantation in subjects with dysfunctional RVOT conduit requiring treatment for moderate or severe pulmonary regurgitation (≥3+ pulmonary regurgitation) and/or RVOT conduit obstruction (mean gradient of \>=35mmHg) by TTE.
Detailed description
The study design is a multi-center, prospective, non-randomized study of up to 70 implanted subjects (US) with no site representing more than 30% of the implanted subjects. The subjects will include those subjects who have previously undergone placement of a conduit between the right ventricle and pulmonary artery and now present with a dysfunctional RVOT conduit requiring treatment for moderate or severe pulmonary regurgitation and/or RVOT conduit obstruction.
Interventions
DEVICESAPIEN Transcatheter Valve Implantation
Device Implantation
Sponsors
Edwards Lifesciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Weight must be equal to or exceed 35 kilograms. 2. In situ conduit size of ≥ 16 mm and ≤ 24 mm in diameter. 3. Subject presents with moderate or severe pulmonary regurgitation defined as ≥3+ pulmonary regurgitation by TTE or RVOT conduit obstruction with a mean gradient of \>= 35 mmHg by TTE. 4. Subject is symptomatic as evidenced by cardiopulmonary exercise testing. 5. The subject or the subject's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site. 6. The subject and the treating physician agree that the subject will return for all required post-procedure follow up visits and the subject will comply with protocol-required follow-up visits. 7. Catheterization is determined to be feasible by the treating physician.
Exclusion criteria
1. Active infection requiring current antibiotic therapy (if temporary illness, subject may be a candidate 4 weeks after discontinuation of antibiotics) 2. Previously enrolled in this study. 3. Subject with pre-existing prosthetic heart valves in any position\*. 4. Severe chest wall deformity. 5. Leukopenia (WBC\<3000 mm3). 6. Acute or chronic anemia (Hb \<9 g/dL).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Freedom From Device or Procedure Related Death or Reintervention | 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Freedom From MACCE | 6 Months | Clinical Events Committee (CEC) adjudicated. |
| Functional Improvement | 6 months | Functional improvement at 6 months as defined by: a) Improved valve hemodynamics as demonstrated via Transthoracic Echo: i) Decrease in pulmonary regurgitation to mild or less for regurgitant lesions ii) Decrease in mean pulmonary gradient to less than 30 mmHg for stenotic lesions iii) Improvement in both i) and ii) above for mixed lesions b) Improvement of ≥ 1 NYHA functional class from baseline for patients with NYHA functional class ≥ 2 at baseline c) Freedom from recurrent pulmonary stenosis. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SAPIEN THV | 79 |
| Total | 79 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Continuing FU | 49 |
| Overall Study | Death | 2 |
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Screen Failure | 2 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | SAPIEN THV |
|---|---|
| Age, Continuous | 28.0 years STANDARD_DEVIATION 13.97 |
| New York Heart Association Group Class I/II | 54 participants |
| New York Heart Association Group Class III/IV | 25 participants |
| Primary Indication Both | 62 participants |
| Primary Indication Pulmonary Regurgitation | 10 participants |
| Primary Indication Pulmonary Stenosis | 7 participants |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 52 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 47 / 79 |
| serious Total, serious adverse events | 38 / 79 |
Outcome results
Primary
Freedom From Device or Procedure Related Death or Reintervention
Time frame: 1 year
Population: Valve implant population. There were 2 screen failure patients and 10 patients where the procedure was started but the study valve not implanted, leaving 69 patients in the Valve Implant Population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SAPIEN THV | Freedom From Device or Procedure Related Death or Reintervention | 97.1 percentage of participants |
95% CI: [0.889, 0.993]
Secondary
Freedom From MACCE
Clinical Events Committee (CEC) adjudicated.
Time frame: 6 Months
Population: Valve implant population. There were 2 screen failure patients and 10 patients where the procedure was started but the study valve not implanted, leaving 69 patients in the Valve Implant Population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SAPIEN THV | Freedom From MACCE | 94.1 percentage of participants |
Comparison: Freedom from Major Adverse Cardiovascular and Cerebrovascular Event (MACCE) at 6 months in the valve implant population.95% CI: [0.851, 0.978]
Secondary
Functional Improvement
Functional improvement at 6 months as defined by: a) Improved valve hemodynamics as demonstrated via Transthoracic Echo: i) Decrease in pulmonary regurgitation to mild or less for regurgitant lesions ii) Decrease in mean pulmonary gradient to less than 30 mmHg for stenotic lesions iii) Improvement in both i) and ii) above for mixed lesions b) Improvement of ≥ 1 NYHA functional class from baseline for patients with NYHA functional class ≥ 2 at baseline c) Freedom from recurrent pulmonary stenosis.
Time frame: 6 months
Population: Valve implant population. There were 2 screen failure patients and 10 patients where procedure was started but the study valve not implanted, leaving 69 patients in the Valve Implant Population. There were 11 additional patients for which data was not available for analysis, leaving 58 patients in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SAPIEN THV | Functional Improvement | 51 participants |
Comparison: Overall functional improvement at 6 months for patients in the valve implant population with baseline and 6 month data.