RESPOND EDGE Post Market Study

Study Overview
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Brief Summary
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The purpose of the RESPOND EDGE post market study is to collect real world clinical and device performance outcomes data with the Lotus Edge™ Valve System used in routine clinical practice to demonstrate that the commercially available Lotus Edge Valve System is a safe and effective treatment for patients with severe calcific aortic stenosis.

Detailed Description
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The RESPOND EDGE study is a prospective, open label, single arm, multi-center, observational post market study designed to collect real world clinical and device performance outcomes data of the commercially available Lotus Edge Valve used in routine clinical practice for the treatment of severe calcific aortic stenosis. Approximately 200 real-world, consecutive subjects will be enrolled at up to 20 study centers. The study duration for each subject is expected to be approximately 2 years. Implanted subjects will be contacted for follow-up at 30 days, 1 and 2 years post index procedure. Subjects who are enrolled but not implanted with a Lotus Edge valve will be followed for safety through 30 days after the initial attempted index procedure. Collection of safety events will include any serious adverse event (SAE), serious adverse device effect (SADE), adverse device effect (ADE), unanticipated serious adverse device effect (USADE), and all Valve Academic Research Consortium (VARC) events regardless of seriousness and device relationship through 2 year follow-up.

Official Title
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Repositionable Lotus Edge™ Valve System - Post Market Evaluation of Real World Clinical Outcomes

Conditions
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Aortic Valve Stenosis

Intervention / Treatment
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* Device: Lotus Edge Device


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Lotus Edge Device|The LOTUS Edge Valve System is indicated to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area [AVA] <1.0 cm2 or AVA index <0.6 cm2/m2) who are at high risk for standard surgical valve replacement.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality (Primary Safety Endpoint) | The primary safety endpoint is all-cause mortality at 30 days after the implant procedure. The primary safety endpoint will be evaluated on an intention to- treat (ITT) basis (all subjects enrolled, whether or not a Lotus Edge Valve is implanted). | 30 days | 
| Mean aortic valve pressure gradient (Primary Effectiveness Endpoint) | The primary effectiveness endpoint is the mean aortic valve pressure gradient (mmHg) at pre-discharge as determined by an independent core laboratory. The primary analysis set for the primary effectiveness endpoint is the implanted analysis set. | Within 7 days after the index procedure (Pre-discharge) |