Aortic Valve StenosisRESPOND EDGENCT04009720
RESPOND EDGE Post Market Study
An observational study of Aortic Valve Stenosis, run by Boston Scientific Corporation at 13 sites in 9 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- Lotus Edge Device
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 13 sitesin 9 countries
- Study dates
- 11 Oct 2019to 2 Jun 2021
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
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.
Trial locations and contacts
13 sites in 9 countries.
13 sites in 9 countries
United Kingdom5 sites
Royal Victoria Belfast
Belfast, BT12 6BA
Royal Sussex County Hospital
Brighton
The General Infirmary
Leeds
Oxford John Radcliffe Hospital
Oxford
New Cross Hospital
Wolverhampton
About this study
Official title: Repositionable Lotus Edge™ Valve System - Post Market Evaluation of Real World Clinical Outcomes
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.
Read the 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.
- Conditions
- Aortic Valve Stenosis
- Being tested
- Lotus Edge Device
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lotus Edge DeviceDevice
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 being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Within 7 days after the index procedure (Pre-discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start11 Oct 2019
- Primary completion9 Dec 2020
- Study completion2 Jun 2021
Why it stopped: study device Lotus Edge was removed from the market
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicolas Dumonteil, MD, Principal investigator, Clinique PasteurRajesh K Kharbanda, MD, PhD, Principal investigator, Oxford Heart Centre, John Radcliffe Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04009720
- Sponsor's protocol ID
- S2361
- Acronym
- RESPOND EDGE
- Status last verified
- Jul 2021
- First submitted
- 2 Jul 2019
- Last updated
- 15 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repositionable Lotus Edge™ Valve System - Post Market Evaluation of Real World Clinical Outcomes
- ClinicalTrials.gov ID
- NCT04009720
- Acronym / sponsor ID
- RESPOND EDGE / S2361
- Conditions
- Aortic Valve Stenosis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: study device Lotus Edge was removed from the market
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 11 Oct 2019 (actual)
- Primary completion
- 9 Dec 2020 (actual)
- Study completion
- 2 Jun 2021 (actual)
- First posted
- 5 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lotus Edge DeviceThe 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. | Device | – |
Primary outcome
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.
Results and safety
The study was stopped early (reason given: study device Lotus Edge was removed from the market). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas Dumonteil, MD principal investigator
Clinique Pasteur
Rajesh K Kharbanda, MD, PhD principal investigator
Oxford Heart Centre, John Radcliffe Hospital
13 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Stenosis, run by Boston Scientific Corporation at 13 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United Kingdom, Denmark, Finland, France, Germany and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: study device Lotus Edge was removed from the market). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (Primary Safety Endpoint) (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2021.