Aortic Stenosis, Aortic Valve Stenosis
Conditions
Keywords
Transcatheter aortic valve implantation (TAVI), SAPIEN 3 Ultra THV, Edwards Lifesciences
Brief summary
This study will evaluate real-world outcomes for the SAPIEN 3 Ultra Transcatheter Heart Valve System in transcatheter aortic valve implantation centres that are implementing minimalist periprocedural practices and facilitating early discharge home.
Detailed description
This is a prospective, observational, single-arm, multicentre, post-market study.
Interventions
Subjects will undergo TAVI
Sponsors
Edwards Lifesciences
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 79 Years
Healthy volunteers
No
Inclusion criteria
1. Will undergo TAVI with the Edwards SAPIEN 3 Ultra System 2. Less than 80 years of age at time of the procedure 3. Low surgical risk 4. Meets clinical and procedural requirements for early discharge 5. The subject or subject's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent
Exclusion criteria
1. Medical, social, or psychological conditions that preclude appropriate consent and follow-up, including subjects under guardianship 2. Considered to be part of a vulnerable population 3. Active SARS-CoV-2 infection (Coronavirus-19 \[COVID-19\]) or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments 4. Cannot tolerate an anticoagulation/antiplatelet regimen 5. Active bacterial endocarditis 6. Participating in a drug or device study that has not reached its primary endpoint
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of Index Hospitalization | Discharge from hospital, expected to be within 1-5 days post-procedure | Number of days in hospital after the procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stroke | 1 year | Number of patients who had a stroke |
| New Requirement for Permanent Pacemaker | 1 year | Number of patients who received a new permanent pacemaker |
| Aortic Valve Reintervention | 1 year | Number of patients who required valve reintervention |
| Death | 1 year | Number of patients who died |
| Mean Gradient | At discharge from hospital, expected to be within 1-5 days post-procedure | Mean gradient (mmHg) |
| Effective Orifice Area | At discharge from hospital, expected to be within 1-5 days post-procedure | Aortic valve area (cm2) |
| Discharge Location | At discharge from hospital, expected to be within 1-5 days post-procedure | Number of patients who were discharged to home or self-care (routine discharge) |
| Aortic Regurgitation | At discharge from hospital, expected to be within 1-5 days post-procedure | Number of patients who had moderate or greater aortic regurgitation |
Countries
Austria, Finland, France, Germany, Italy, Norway, Portugal, Spain, Switzerland, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Transcatheter Aortic Valve Implantation (TAVI) Patients receive Transcatheter Aortic Valve Implantation (TAVI) | 500 |
| Total | 500 |
Baseline characteristics
| Characteristic | Transcatheter Aortic Valve Implantation (TAVI) | — |
|---|---|---|
| Age, Continuous | 74.7 years STANDARD_DEVIATION 4.11 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 217 Participants | — |
| Sex: Female, Male Male | 283 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 9 / 500 |
| other Total, other adverse events | 42 / 500 |
| serious Total, serious adverse events | 157 / 500 |
Outcome results
Primary
Length of Index Hospitalization
Number of days in hospital after the procedure
Time frame: Discharge from hospital, expected to be within 1-5 days post-procedure
Population: As treated - all patients enrolled in the trial
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transcatheter Aortic Valve Implantation (TAVI) | Length of Index Hospitalization | 3.3 days | Standard Error 0.11 |
Secondary
Aortic Regurgitation
Number of patients who had moderate or greater aortic regurgitation
Time frame: At discharge from hospital, expected to be within 1-5 days post-procedure
Population: Patients implanted with study valve who received an echocardiogram at discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transcatheter Aortic Valve Implantation (TAVI) | Aortic Regurgitation | 2 Participants |
Secondary
Aortic Valve Reintervention
Number of patients who required valve reintervention
Time frame: 1 year
Population: As treated - all patients enrolled in the trial
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transcatheter Aortic Valve Implantation (TAVI) | Aortic Valve Reintervention | 3 Participants |
Secondary
Death
Number of patients who died
Time frame: 1 year
Population: As treated - all patients enrolled in the trial
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transcatheter Aortic Valve Implantation (TAVI) | Death | 9 Participants |
Secondary
Discharge Location
Number of patients who were discharged to home or self-care (routine discharge)
Time frame: At discharge from hospital, expected to be within 1-5 days post-procedure
Population: As treated - all patients enrolled in the trial
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Transcatheter Aortic Valve Implantation (TAVI) | Discharge Location | 436 participants |
Secondary
Effective Orifice Area
Aortic valve area (cm2)
Time frame: At discharge from hospital, expected to be within 1-5 days post-procedure
Population: Patients implanted with study valve who received an echocardiogram at discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transcatheter Aortic Valve Implantation (TAVI) | Effective Orifice Area | 1.6 cm2 | Standard Error 0.02 |
Secondary
Mean Gradient
Mean gradient (mmHg)
Time frame: At discharge from hospital, expected to be within 1-5 days post-procedure
Population: Patients implanted with study valve who received an echocardiogram at discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transcatheter Aortic Valve Implantation (TAVI) | Mean Gradient | 12.8 mmHg | Standard Error 0.24 |
Secondary
New Requirement for Permanent Pacemaker
Number of patients who received a new permanent pacemaker
Time frame: 1 year
Population: As treated - all patients enrolled in the trial who did not previously have a permanent pacemaker implanted
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transcatheter Aortic Valve Implantation (TAVI) | New Requirement for Permanent Pacemaker | 51 Participants |
Secondary
Stroke
Number of patients who had a stroke
Time frame: 1 year
Population: As treated - all patients enrolled in the trial
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transcatheter Aortic Valve Implantation (TAVI) | Stroke | 7 Participants |