Aortic Valve DiseaseREBOOTNCT02668484
REpositionable Versus BallOOn-expandable Prosthesis for Trans-catheter Aortic Valve Implantation
A study testing repositionable valve prosthesis and balloon-expandable valve prosthesis in people with Aortic Valve Disease, run by LMU Klinikum at 3 sites in 2 countries.
Trial summary
There are different aortic valve prosthesis used for treatment of aortic valve disease through catheter-based procedures. The current study aims to compare two different aortic valve prosthesis regarding their outcomes at 30-day and 2-year follow-up. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Disease
- What is being tested?
- repositionable valve prosthesis and balloon-expandable valve prosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Jan 2016to 31 May 2019
- Phase
- Interventional
- 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
Who may be able to join
- Symptomatic aortic valve disease in need of valve replacement
- Heart team (including at least a cardiac surgeon and an interventional cardiologist) agrees on the eligibility that trans-femoral TAVI is appropriate.
- Study patient is an adult of legal consent age.
- Study patient has provided written informed consent to participate in the study
Who cannot join
- Life expectancy < 12 months due to co-morbid conditions.
- Native aortic valve annulus size and morphology not suitable for Lotus or Sapien prosthesis implantation
- Preexisting bioprosthetic valve or ring in aortic valve position.
- Pre-existing pacemaker or ICD/CRT.
- Cardiogenic shock or hemodynamic instability.
- History of active endocarditis
Show all 13Show fewer
- Contraindications for a trans-femoral access.
- Severe left ventricular dysfunction with LVEF <30%.
- Severe mitral valve insufficiency.
- Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
- Patients actively participating in another drug or device investigational study and have not yet completed the primary endpoint follow-up period.
- Patients suffering from dementia.
- Pregnant or nursing women
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Germany2 sites
Segeberger Kliniken Gmbh
Bad Segeberg, Schleswig-Holstein, 23795
Munich University Clinic, Ludwig-Maximilians University
Munich, Bavaria, 81377
About this study
Official title: Randomized Comparison of Repositionable and Balloon-Expandable Prostheses in Patients Undergoing Trans-catheter Aortic Valve Implantation
There are different aortic valve prosthesis used for treatment of aortic valve disease through catheter-based procedures. The current study aims to compare two different aortic valve prosthesis regarding their outcomes at 30-day and 2-year follow-up.
Read the detailed description
Important improvements in aortic valve prostheses technology has been made aiming comparable performance of these prosthesis to surgical valve ones.
The experience with the early generation of aortic valve prostheses revealed some important differences regarding the incidence of paravalvular leakage, need for pacemaker or valve thrombosis among them. Currently the new generations of valve prostheses such as Sapien 3 balloon-expandable valve and Lotus, repositionable valve are the most frequently used devices. There are registry data about the clinical performance of these valve types but a randomized comparison is missing.
- Conditions
- Aortic Valve Disease
- Being tested
- repositionable valve prosthesis, balloon-expandable valve prosthesis
- Keywords
- TAVI, trans-femoral, Sapien, Lotus
- Medical subject headings
- Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repositionable valve prosthesisDevice
Also called Lotus
repositionable valve prosthesis implanted via trans-femoral and trans-catheter route
balloon-expandable valve prosthesisDevice
Also called Sapien
balloon-expandable valve prosthesis implanted via trans-femoral and trans-catheter route
| Study group | Role | What they receive |
|---|---|---|
| repositionable valve prosthesis | Experimental | Lotus Receives: Device: repositionable valve prosthesis |
| balloon-expandable valve prosthesis | Active comparator | Sapien Receives: Device: balloon-expandable valve prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of new permanent pacemaker implantation
implantation of PM
Measured: 30 days
Secondary outcomes (9)
incidence of any prosthesis regurgitation
prosthesis regurgitation in echocardiography
Measured: 30 days
Incidence of any conduction abnormalities
conduction abnormalities on rest ECG
Measured: 30 days
Device success rate according to VARC-2 definition
combined endpoint
Measured: 30 days
Mortality rate
all-cause death
Measured: 30 days
Mortality rate
all-cause death
Measured: 1 year
Mortality rate
all-cause death
Measured: 2 years
incidence of early safety parameters according to VARC-2 definitions
combined endpoint
Measured: 30 days
incidence of combined efficacy according to VARC-2 definitions
combined endpoint
Measured: 1 year
incidence of combined efficacy according to VARC-2 definitions
combined endpoint
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionMay 2017
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve DiseaseStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- LMU Klinikum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Julinda Mehilli, LMU Klinikum
- Investigators
- Julinda Mehilli, MD, Principal investigator, Munich University Clinic, Ludwig-Maximilians University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02668484
- Sponsor's protocol ID
- GEMucS001-15
- Acronym
- REBOOT
- Status last verified
- May 2019
- First submitted
- 26 Jan 2016
- Last updated
- 3 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparison of Repositionable and Balloon-Expandable Prostheses in Patients Undergoing Trans-catheter Aortic Valve Implantation
- ClinicalTrials.gov ID
- NCT02668484
- Acronym / sponsor ID
- REBOOT / GEMucS001-15
- Conditions
- Aortic Valve Disease
- Keywords
- TAVI, trans-femoral, Sapien, Lotus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- LMU KlinikumUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 29 Jan 2016 (estimated)
- 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.
There are different aortic valve prosthesis used for treatment of aortic valve disease through catheter-based procedures. The current study aims to compare two different aortic valve prosthesis regarding their outcomes at 30-day and 2-year follow-up.
Detailed description
Important improvements in aortic valve prostheses technology has been made aiming comparable performance of these prosthesis to surgical valve ones.
The experience with the early generation of aortic valve prostheses revealed some important differences regarding the incidence of paravalvular leakage, need for pacemaker or valve thrombosis among them. Currently the new generations of valve prostheses such as Sapien 3 balloon-expandable valve and Lotus, repositionable valve are the most frequently used devices. There are registry data about the clinical performance of these valve types but a randomized comparison is missing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| repositionable valve prosthesis | Experimental | Device: repositionable valve prosthesisLotus |
| balloon-expandable valve prosthesis | Active comparator | Device: balloon-expandable valve prosthesisSapien |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Symptomatic aortic valve disease in need of valve replacement
- Heart team (including at least a cardiac surgeon and an interventional cardiologist) agrees on the eligibility that trans-femoral TAVI is appropriate.
- Study patient is an adult of legal consent age.
- Study patient has provided written informed consent to participate in the study
Key exclusion criteria (13 listed)
- Life expectancy < 12 months due to co-morbid conditions.
- Native aortic valve annulus size and morphology not suitable for Lotus or Sapien prosthesis implantation
- Preexisting bioprosthetic valve or ring in aortic valve position.
- Pre-existing pacemaker or ICD/CRT.
- Cardiogenic shock or hemodynamic instability.
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 |
|---|---|---|
| repositionable valve prosthesisAlso: Lotusrepositionable valve prosthesis implanted via trans-femoral and trans-catheter route | Device | repositionable valve prosthesis |
| balloon-expandable valve prosthesisAlso: Sapienballoon-expandable valve prosthesis implanted via trans-femoral and trans-catheter route | Device | balloon-expandable valve prosthesis |
Primary outcome
Incidence of new permanent pacemaker implantation
Time frame: 30 days
implantation of PM
9 secondary outcomes
incidence of any prosthesis regurgitation
Time frame: 30 days
Incidence of any conduction abnormalities
Time frame: 30 days
Device success rate according to VARC-2 definition
Time frame: 30 days
Mortality rate
Time frame: 30 days
Mortality rate
Time frame: 1 year
Mortality rate
Time frame: 2 years
incidence of early safety parameters according to VARC-2 definitions
Time frame: 30 days
incidence of combined efficacy according to VARC-2 definitions
Time frame: 1 year
incidence of combined efficacy according to VARC-2 definitions
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2019.
- 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.
Julinda Mehilli, MD principal investigator
Munich University Clinic, Ludwig-Maximilians University
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing repositionable valve prosthesis and balloon-expandable valve prosthesis in people with Aortic Valve Disease, run by LMU Klinikum at 3 sites in 2 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 4 inclusion and 13 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 3 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, Italy. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of new permanent pacemaker implantation (time frame: 30 days). 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 3 Jun 2019.