N/A
N=1,064
RESPOND Post Market Study
Aortic Valve Stenosis
Bottom Line
View on ClinicalTrials.gov: NCT02031302 ↗Enrolled (actual)
1,064
Serious AEs
46.4%
Results posted
Nov 2019
Primary outcome: Primary: All-cause Mortality — 26; 0 Participants — p=<.0001
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Lotus Valve System (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Boston Scientific Corporation
- Primary completion
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY All-cause Mortality |
120 | — |
| PRIMARY All-cause Mortality |
120 | — |
| SECONDARY Percentage of Participants With Events Included in the Safety Composite Endpoint of All-Cause Mortality and Disabling Stroke |
41; 1; 135; 0 | — |
| SECONDARY In-hospital Mortality |
18; 0 | — |
| SECONDARY Percentage of Participants With Events Included in the VARC Efficacy Composite Endpoint |
200 | — |
| SECONDARY Patients With Valve Safety Composite Outcomes at 1 Year |
219 | — |
| SECONDARY Patients With VARC Safety Composite Outcomes at 30 Days |
334; 10 | — |
| SECONDARY Patients With Moderate and Severe Paravalvular Aortic Valve Regurgitation |
179; 13 | — |
Summary
The purpose of the RESPOND post market study is to collect real world clinical and device performance outcomes data with the Lotus Valve System used in routine clinical practice to demonstrate that the commercially available Lotus Valve System is a safe and effective treatment for patients with severe calcific aortic stenosis.
Eligibility Criteria
Subjects will be evaluated for eligibility by the clinical center's heart team per the local standard of practice in accordance with the Directions for Use.
Data sourced from ClinicalTrials.gov (NCT02031302). 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.