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RESPOND EDGE Post Market Study (RESPOND EDGE)
| Condition or disease | Intervention/treatment |
|---|---|
| Aortic Valve Stenosis | Device: Lotus Edge Device |
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.
| Study Type : | Observational [Patient Registry] |
| Actual Enrollment : | 200 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 2 Years |
| Official Title: | Repositionable Lotus Edge™ Valve System - Post Market Evaluation of Real World Clinical Outcomes |
| Actual Study Start Date : | October 11, 2019 |
| Actual Primary Completion Date : | December 9, 2020 |
| Estimated Study Completion Date : | December 31, 2022 |
- All-cause mortality (Primary Safety Endpoint) [ Time Frame: 30 days ]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).
- Mean aortic valve pressure gradient (Primary Effectiveness Endpoint) [ Time Frame: Within 7 days after the index procedure (Pre-discharge) ]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.
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date | July 2, 2019 | ||||||
| First Posted Date | July 5, 2019 | ||||||
| Last Update Posted Date | June 4, 2021 | ||||||
| Actual Study Start Date | October 11, 2019 | ||||||
| Actual Primary Completion Date | December 9, 2020 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures |
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| Original Primary Outcome Measures | Same as current | ||||||
| Change History | |||||||
| Current Secondary Outcome Measures | Not Provided | ||||||
| Original Secondary Outcome Measures | Not Provided | ||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title | RESPOND EDGE Post Market Study | ||||||
| Official Title | Repositionable Lotus Edge™ Valve System - Post Market Evaluation of Real World Clinical Outcomes | ||||||
| Brief Summary | 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 |
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. |
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| Study Type | Observational [Patient Registry] | ||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | 2 Years | ||||||
| Biospecimen | Not Provided | ||||||
| Sampling Method | Non-Probability Sample | ||||||
| Study Population | All subjects who are candidates for Transcatheter Aortic Valve Implantation (TAVI), signed the Informed Consent Form and are selected to receive a LOTUS Edge valve will be evaluated for enrollment in this study. | ||||||
| Condition | Aortic Valve Stenosis | ||||||
| Intervention | 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.
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| Study Groups/Cohorts | Not Provided | ||||||
| Publications * | Not Provided | ||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status | Active, not recruiting | ||||||
| Actual Enrollment |
200 | ||||||
| Original Estimated Enrollment | Same as current | ||||||
| Estimated Study Completion Date | December 31, 2022 | ||||||
| Actual Primary Completion Date | December 9, 2020 (Final data collection date for primary outcome measure) | ||||||
| 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. | ||||||
| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers | No | ||||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries | Denmark, Finland, France, Germany, Ireland, Italy, Netherlands, Sweden, United Kingdom | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number | NCT04009720 | ||||||
| Other Study ID Numbers | S2361 | ||||||
| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Boston Scientific Corporation | ||||||
| Study Sponsor | Boston Scientific Corporation | ||||||
| Collaborators | Not Provided | ||||||
| Investigators |
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| PRS Account | Boston Scientific Corporation | ||||||
| Verification Date | June 2021 | ||||||
