Transcatheter Aortic Valve ReplacementNCT01627691
REPRISE II: REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve System
A study testing Lotus Valve System in people with Transcatheter Aortic Valve Replacement, run by Boston Scientific Corporation at 20 sites in 9 countries.
Trial summary
The purpose of this study is to evaluate the safety and performance of the Lotus™ Valve System for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with severe calcific aortic stenosis who are considered high risk for surgical valve replacement. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Transcatheter Aortic Valve Replacement
- What is being tested?
- Lotus Valve System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 20 sitesin 9 countries
- Study dates
- 8 Oct 2012to 13 May 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Subject is ≥70 years of age
- Subject has documented calcific native aortic valve stenosis
- Subject has a documented aortic annulus size between ≥19 and ≤27 mm based on pre-procedure diagnostic imaging
- Symptomatic aortic valve stenosis with NYHA Functional Class ≥ II
- Subject is considered high risk for surgical valve replacement
- Heart team assessment that the subject is likely to benefit from valve replacement.
- Subject (or legal representative) understands the study requirements and the treatment procedures, and provides written informed consent.
- Subject, family member, and/or legal representative agree(s) and subject is capable of returning to the study hospital for all required scheduled follow up visits.
Who cannot join
- Subject has a congenital unicuspid or bicuspid aortic valve.
- Subject with an acute myocardial infarction within 30 days of the index procedure
- Subject has had a cerebrovascular accident or transient ischemic attack within the past 6 months, or has any permanent neurologic defect prior to study enrollment.
- Subject is on dialysis or has serum creatinine level >3.0 mg/dL or 265 µmol/L.
- Subject has a pre-existing prosthetic heart valve (aortic or mitral) or a prosthetic ring in any position.
- subject cannot have more than moderate mitral, aortic or tricuspid regurgitation
Show all 24Show fewer
- Subject has a need for emergency surgery for any reason.
- Subject has a history of endocarditis within 12 months of index procedure or evidence of an active systemic infection or sepsis.
- Subject has echocardiographic evidence of intra-cardiac mass, thrombus or vegetation.
- Subject has low Hgb, platelet count or >700,000 cells/mm3, or low white blood cell count.
- Subject requires chronic anticoagulation therapy and cannot tolerate concomitant therapy with either aspirin or clopidogrel/ticlopidine
- Subject has active peptic ulcer disease or gastrointestinal bleed within the past 3 months, other bleeding diathesis or coagulopathy or will refuse transfusions.
- Subject has known hypersensitivity to contrast agents that cannot be adequately pre-medicated, or has known hypersensitivity to aspirin, all thienopyridines, heparin, nickel, tantalum, titanium, or polyurethanes.
- Subject has a life expectancy of less than 12 months due to non-cardiac, co-morbid conditions based on the assessment of the investigator at the time of enrollment.
- Subject has hypertrophic obstructive cardiomyopathy.
- Subject has any therapeutic invasive cardiac procedure within 30 days prior to the index procedure (except for pacemaker implantation which is allowed).
- Subject has untreated coronary artery disease.
- Subject has documented left ventricular ejection fraction <30%.
- Subject is in cardiogenic shock or has hemodynamic instability requiring inotropic support or mechanical support devices.
- Subject has severe peripheral vascular disease or symptomatic carotid or vertebral disease.
- Narrow Femoral artery lumen precludes the use of either Lotus device size, or severe iliofemoral tortuosity or calcification that would prevent safe placement of the introducer sheath.
- Current problems with substance abuse (e.g., alcohol, etc.).
- Subject is participating in another investigational drug or device study that has not reached its primary endpoint.
- Patient has preexisting untreated conduction system disorder that requires new pacemaker implantation.
Trial locations and contacts
20 sites in 9 countries.
20 sites in 9 countries
France5 sites
Hôpital Cardiologique CHRU de Lille
Lille
Hôpital Cardiologique de Lyon
Lyon
Institut Cardiovasculaire Paris Sud
Paris
Centre Hôpital Universitaire Rangueil
Toulouse
Clinique Pasteur
Toulouse
Australia4 sites
Royal Adelaide Hospital
Adelaide
Prince Charles Hospital
Brisbane
Monash Medical Center
Melbourne
St. Vincent's Hospital
Melbourne
United Kingdom4 sites
Royal Victoria Hospital
Belfast
Royal Sussex County Hospital
Brighton
The General Infirmary
Leeds
Guys and St. Thomas NHS Foundation Trust
London
Germany2 sites
Deutsches Herzzentrum München
München
Helios Klinikum Siegburg
Siegburg
About this study
Official title: REPRISE II: REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve System - Evaluation of Safety and Performance
The purpose of this study is to evaluate the safety and performance of the Lotus™ Valve System for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with severe calcific aortic stenosis who are considered high risk for surgical valve replacement.
Read the detailed description
The REPRISE II clinical study is a prospective, single-arm, multicenter study designed to evaluate the safety and performance of the Lotus Valve System for TAVR in symptomatic subjects who have severe calcific aortic valve stenosis and who are at high risk for surgical aortic valve replacement (SAVR).
- Conditions
- Transcatheter Aortic Valve Replacement
- Being tested
- Lotus Valve System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lotus Valve SystemDevice
- bioprosthetic bovine pericardial aortic valve
- delivery system
| Study group | Role | What they receive |
|---|---|---|
| Lotus Valve System | Experimental | Patients enrolled will receive the Lotus Valve. Receives: Device: Lotus Valve System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Device Performance Endpoint: Mean Aortic Valve Pressure Gradient at 30 Days Post Implant Procedure
Mean aortic valve pressure gradient at 30 days post implant procedure as measured by echocardiography and assessed by an independent core laboratory.
Measured: 30 days
Primary Safety Endpoint: All-cause Mortality at 30 Days Post Implant Procedure
Mortality at 30 days from all patients enrolled in the study (ITT population): the proportion of patients who experience an event through 30 days post-procedure out of the patients who have either had an event within 30 days post-procedure or who were event-free with last follow-up at least 23 days post-procedure
Measured: 30 days
Secondary outcomes (6)
Effective Orifice Area
Effective orifice area measured by echocardiography at 30 days and assessed by an independent core laboratory (ITT population)
Measured: 30 days
Device Performance Endpoint: Successful Vascular Access
Successful vascular access, delivery and deployment of the Lotus Valve System and successful retrieval of the delivery system as reported from site
Measured: Post-procedure
Device Performance Endpoint: Successful Retrieval
Successful retrieval (complete resheathing of the Lotus valve in the catheter and removal from the body) of the Lotus Valve System if retrieval is attempted, as reported from site
Measured: Post-procedure
Device Performance Endpoint: Successful Repositioning
Successful repositioning (partial or complete resheathing of the Lotus Valve in the catheter and redeployment in a more accurate position within the aortic valve annulus) of the Lotus Valve System if repositioning is attempted for the last valve attempted, as reported from site
Measured: Post-procedure
Device Success According to the Valve Academic Research Consortium (VARC)
Absence of procedural mortality as reported from site AND Correct positioning of a single prosthetic heart valve into the proper anatomical location as reported from site AND Intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient <20 mmHg or peak velocity <3 m/s, AND no moderate or severe prosthetic valve regurgitation as measured from an independent core lab on the post-procedure echocardiography)
Measured: Post-procedure
Grade of Aortic Valve Regurgitation
Grade of paravalvular aortic valve regurgitation at 30 days as measured by echocardiography and assessed by an independent core laboratory
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2012 (estimated)
- Study start8 Oct 2012
- Primary completion30 May 2014
- Study completion13 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Transcatheter Aortic Valve ReplacementStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicolas Dumonteil, MD, Principal investigator, Clinique Pasteur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01627691
- Sponsor's protocol ID
- TP3687
- Other IDs
- TP3687
- Status last verified
- Apr 2020
- First submitted
- 5 Jun 2012
- Last updated
- 12 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Meredith IT, Walters DL, Dumonteil N, Worthley SG, Tchetche D, Manoharan G, Blackman DJ, Rioufol G, Hildick-Smith D, Whitbourn RJ, Lefevre T, Lange R, Muller R, Redwood S, Feldman TE, Allocco DJ, Dawkins KD. 1-Year Outcomes With the Fully Repositionable and Retrievable Lotus Transcatheter Aortic Replacement Valve in 120 High-Risk Surgical Patients With Severe Aortic Stenosis: Results of the REPRISE II Study. JACC Cardiovasc Interv. 2016 Feb 22;9(4):376-384. doi: 10.1016/j.jcin.2015.10.024.
PubMed 26892084Meredith Am IT, Walters DL, Dumonteil N, Worthley SG, Tchetche D, Manoharan G, Blackman DJ, Rioufol G, Hildick-Smith D, Whitbourn RJ, Lefevre T, Lange R, Muller R, Redwood S, Allocco DJ, Dawkins KD. Transcatheter aortic valve replacement for severe symptomatic aortic stenosis using a repositionable valve system: 30-day primary endpoint results from the REPRISE II study. J Am Coll Cardiol. 2014 Sep 30;64(13):1339-48. doi: 10.1016/j.jacc.2014.05.067.
PubMed 25257635
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REPRISE II: REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve System - Evaluation of Safety and Performance
- ClinicalTrials.gov ID
- NCT01627691
- Acronym / sponsor ID
- TP3687
- Conditions
- Transcatheter Aortic Valve Replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 8 Oct 2012 (actual)
- Primary completion
- 30 May 2014 (actual)
- Study completion
- 13 May 2019 (actual)
- First posted
- 26 Jun 2012 (estimated)
- Results
- Posted 10 Sep 2019
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 this study is to evaluate the safety and performance of the Lotus™ Valve System for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with severe calcific aortic stenosis who are considered high risk for surgical valve replacement.
Detailed description
The REPRISE II clinical study is a prospective, single-arm, multicenter study designed to evaluate the safety and performance of the Lotus Valve System for TAVR in symptomatic subjects who have severe calcific aortic valve stenosis and who are at high risk for surgical aortic valve replacement (SAVR).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lotus Valve System | Experimental | Device: Lotus Valve SystemPatients enrolled will receive the Lotus Valve. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- Subject is ≥70 years of age
- Subject has documented calcific native aortic valve stenosis
- Subject has a documented aortic annulus size between ≥19 and ≤27 mm based on pre-procedure diagnostic imaging
- Symptomatic aortic valve stenosis with NYHA Functional Class ≥ II
- Subject is considered high risk for surgical valve replacement
Key exclusion criteria (24 listed)
- Subject has a congenital unicuspid or bicuspid aortic valve.
- Subject with an acute myocardial infarction within 30 days of the index procedure
- Subject has had a cerebrovascular accident or transient ischemic attack within the past 6 months, or has any permanent neurologic defect prior to study enrollment.
- Subject is on dialysis or has serum creatinine level >3.0 mg/dL or 265 µmol/L.
- Subject has a pre-existing prosthetic heart valve (aortic or mitral) or a prosthetic ring in any position.
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 Valve System* bioprosthetic bovine pericardial aortic valve * delivery system | Device | Lotus Valve System |
Primary outcome
Primary Device Performance Endpoint: Mean Aortic Valve Pressure Gradient at 30 Days Post Implant Procedure
Time frame: 30 days
Mean aortic valve pressure gradient at 30 days post implant procedure as measured by echocardiography and assessed by an independent core laboratory.
Primary Safety Endpoint: All-cause Mortality at 30 Days Post Implant Procedure
Time frame: 30 days
Mortality at 30 days from all patients enrolled in the study (ITT population): the proportion of patients who experience an event through 30 days post-procedure out of the patients who have either had an event within 30 days post-procedure or who were event-free with last follow-up at least 23 days post-procedure
6 secondary outcomes
Effective Orifice Area
Time frame: 30 days
Device Performance Endpoint: Successful Vascular Access
Time frame: Post-procedure
Device Performance Endpoint: Successful Retrieval
Time frame: Post-procedure
Device Performance Endpoint: Successful Repositioning
Time frame: Post-procedure
Device Success According to the Valve Academic Research Consortium (VARC)
Time frame: Post-procedure
Grade of Aortic Valve Regurgitation
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26892084Meredith IT, Walters DL, Dumonteil N, Worthley SG, Tchetche D, Manoharan G, Blackman DJ, Rioufol G, Hildick-Smith D, Whitbourn RJ, Lefevre T, Lange R, Muller R, Redwood S, Feldman TE, Allocco DJ, Dawkins KD. 1-Year Outcomes With the Fully Repositionable and Retrievable Lotus Transcatheter Aortic Replacement Valve in 120 High-Risk Surgical Patients With Severe Aortic Stenosis: Results of the REPRISE II Study. JACC Cardiovasc Interv. 2016 Feb 22;9(4):376-384. doi: 10.1016/j.jcin.2015.10.024.
- Derived from this study: PubMed 25257635Meredith Am IT, Walters DL, Dumonteil N, Worthley SG, Tchetche D, Manoharan G, Blackman DJ, Rioufol G, Hildick-Smith D, Whitbourn RJ, Lefevre T, Lange R, Muller R, Redwood S, Allocco DJ, Dawkins KD. Transcatheter aortic valve replacement for severe symptomatic aortic stenosis using a repositionable valve system: 30-day primary endpoint results from the REPRISE II study. J Am Coll Cardiol. 2014 Sep 30;64(13):1339-48. doi: 10.1016/j.jacc.2014.05.067.
- Individual participant dataSharing planned: No
Related trials for Transcatheter Aortic Valve Replacement
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Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
RecruitingObservational study
Valve Performance of the SAPIEN 3 Ultra RESILIA Valve: A Prospective Registry With Central Echocardiography Analysis.
Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement
Not yet recruitingObservational study
Evaluation of a Management Algorithm for TAVI Patients With Concomitant Mitral or Tricuspid Regurgitation
Aortic Stenosis, Mitral Regurgitation
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
20 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lotus Valve System in people with Transcatheter Aortic Valve Replacement, run by Boston Scientific Corporation at 20 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?
The sponsor lists 8 inclusion and 24 exclusion criteria. 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: finished, as of the sponsor's last update on 12 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in France, Australia, United Kingdom, Germany, Italy 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?
Yes. Results are posted in the registry (first posted 10 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Primary Device Performance Endpoint: Mean Aortic Valve Pressure Gradient at 30 Days Post Implant Procedure (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?
On the ClinicalTrials.gov record for NCT01627691, which also lists 2 linked publications.
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 12 May 2020.