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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P180029 / PAS002 |
| Date Original Protocol Accepted |
12/06/2019
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| Date Current Protocol Accepted |
03/30/2021
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| Study Name |
RWU of LOTUS Edge Valve System
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| Device Name |
LOTUS Edge Valve System
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| General Study Protocol Parameters |
| Study Design |
Comprehensive/Linked/RegistryBased Surveillance
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| Data Source |
External Registry
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| Comparison Group |
No Control
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| Analysis Type |
Descriptive
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| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
To monitor device performance and assess safety and effectiveness outcomes associated with use of the LOTUS Edge™ Valve System (LOTUS Edge) for transcatheter aortic valve replacement (TAVR) in routine clinical practice using data collected in the Society of Thoracic Surgeons/American College of Cardiology (STS/ACC) Transcatheter Valve Therapy Registry (TVT Registry™). Additionally, longer-term safety and effectiveness will be monitored using linkage to CMS claims data for outcomes and adverse events starting with the end of one-year post-implant through five years post-implant.
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| Study Population |
All patients with an attempted LOTUS Edge valve implant in the aortic position, and entered into the TVT Registry, from the date of PMA approval (April 23, 2019) through June 30, 2021.
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| Sample Size |
There is no minimum sample size. It is anticipated that approximately 2000 patients will receive an attempted LOTUS Edge implant during this time period and will be entered into the TVT Registry.
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| Key Study Endpoints |
This surveillance will monitor the following: (1) device success (intra-procedure); (2) all-cause mortality, all stroke, life-threatening/major bleeding, new requirement for dialysis, peri-procedural myocardial infarction, and repeat procedure for valve-related dysfunction (surgical or interventional therapy) at 30 days and 12 months; (3) neurological (non-stroke), vascular complications, and quality of life (KCCQ) outcomes at 30 days and 12 months; and (4) all-cause mortality, all stroke, and repeat procedure for valve-related dysfunction (surgical or interventional therapy) at 2-5 year post implantation.
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| Follow-up Visits and Length of Follow-up |
Successfully implanted patients will be followed through the registry for one year, and patients who can be linked to CMS claims data will be followed through five years. Patients with attempted but unsuccessful implants will be followed through discharge.
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
1685 (Attempted implant - ITT)
1661 (Implanted)
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| Actual Number of Sites Enrolled |
161 participating centers
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| Patient Follow-up Rate |
97.5% overall follow-up rate for both ITT & Implanted at 30 days
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| Final Safety Findings |
Site-reported Safety Outcomes at 30 Days – Implanted Patients:
All-cause mortality: 3.8% (61/1592)
Stroke: 4.1% (66/1592)
Aortic valve reintervention: 0.1% (1/1592)
Major bleeding event: 1.2% (19/1592)
Myocardial infarction: 0.4% (6/1592)
New permanent pacemaker: 28.5% (453/1592)
Atrial fibrillation: 1.6% (25/1592)
The average morbidity and mortality (STS) risk score in this population at baseline was 4.8%+/-3.8 compared to 6.7%+/-4.0 in the RCT. This may indicate that the average operative risk in the TVT population was lower than the average operative risk for patients in the RCT.
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| Final Effect Findings |
Implanted Patients:
From baseline to 30 days, 79% of patients improved by at least one NYHA functional class and 36.3% improved by at least 2 NYHA functional classes.
KCCQ overall summary score change from baseline at 30 days: 22.6 +/- 27.12
Mean Gradient at 30 days: 12.88 /-+ 6.56 mmHg
Aortic valve area post procedure: 1.85 +/- 0.58 cm2
At 30 days, paravalvular aortic regurgitation was graded: 80.3% none, 11.8% mild, 1% moderate, 0.1% severe, and 6.8% not documented.
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| Study Strengths & Weaknesses |
This study was intended to evaluate the longer-term safety and effectiveness of the LOTUS Edge Valve System (through 5 years). Due to voluntary recall and discontinuation of the LOTUS Edge system, the study timeline was truncated and safety and effectiveness data is presented through 30 day follow-up only; thus, long-term outcomes are not available from this study. The overall follow-up rate at 30 days was 97.5% for both ITT & implanted populations, and acute outcomes continue to support early safety and performance of the device. It should be noted that some subjects did not complete all visit assessments (e.g., echocardiographic imaging) and/or withdrew or were lost to follow-up. Incomplete data may introduce bias to study outcomes.
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| Recommendations for Labeling Changes |
No labeling changes recommended. The device has been recalled and discontinued, and is no longer commercially available.
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