N/A
N=197
PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - Nested Registry 3/Valve-in-Valve
Aortic Stenosis · Cardiomyopathy, Hypertrophic
Bottom Line
View on ClinicalTrials.gov: NCT03225001 ↗Enrolled (actual)
197
Serious AEs
55.9%
Results posted
Jan 2018
Primary outcome: Primary: Number of Participants With All-Cause Mortality, All Stroke, Moderate or Severe Obstruction, or Moderate or Severe Paravalvular Leak (Composite) — 28 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Edwards SAPIEN XT transcatheter valve, Model 9300TFX (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Edwards Lifesciences
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With All-Cause Mortality, All Stroke, Moderate or Severe Obstruction, or Moderate or Severe Paravalvular Leak (Composite) |
28 | — |
| SECONDARY Number of Participants With Mortality From Any Cause |
8 | — |
Summary
To assess the safety and effectiveness of the SAPIEN XT transcatheter heart valve in patients with a failing surgical aortic bioprosthetic valve.
Eligibility Criteria
Inclusion Criteria
- Patient has senile degenerative aortic valve stenosis with echocardiographically derived criteria: mean gradient >40 mmHg or jet velocity greater than 4.0 m/s and an initial aortic valve area (AVA) of ≤0.8 cm2 or indexed EOA < 0.5 cm2/m2. Qualifying echo must be within 60 days of the date of the procedure.
- Patient was symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater.
- The heart team agreed (and verified in the case review process) that valve implantation would likely benefit the patient.
- The study patient or the study patient's legal representative was informed of the nature of the study, agreed to its provisions and had provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.
- Heart team consensus that the risk of surgical mortality or major morbidity ≥ 50%.
- Stenosed or insufficient surgically implanted bioprosthetic valve in the aortic position.
Exclusion Criteria
- Bioprosthetic valve labeled external diameter < 21mm.
- Surgical or transcatheter valve in another position on the same side of the heart (mitral and tricuspid rings are not an exclusion).
- Infectious endocarditis within 6 months.
- Acute myocardial infarction ≤ 1 month (30 days) before the intended treatment.
Data sourced from ClinicalTrials.gov (NCT03225001). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.