Back to resultsREpositionable Versus BallOOn-expandable Prosthesis for Trans-catheter Aortic Valve Implantation (REBOOT)
Primary Purpose
Aortic Valve Disease
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
repositionable valve prosthesis
balloon-expandable valve prosthesis
Sponsored by
About this trial
This is an interventional treatment trial for Aortic Valve Disease focused on measuring TAVI, trans-femoral, Sapien, Lotus
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Sites / Locations
- Munich University Clinic, Ludwig-Maximilians University
- Segeberger Kliniken Gmbh
- Azienda Ospedaliero-Universitaria Pisana
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
repositionable valve prosthesis
balloon-expandable valve prosthesis
Arm Description
Lotus
Sapien
Outcomes
Primary Outcome Measures
Incidence of new permanent pacemaker implantation
implantation of PM
Secondary Outcome Measures
incidence of any prosthesis regurgitation
prosthesis regurgitation in echocardiography
Incidence of any conduction abnormalities
conduction abnormalities on rest ECG
Device success rate according to VARC-2 definition
combined endpoint
Mortality rate
all-cause death
Mortality rate
all-cause death
Mortality rate
all-cause death
incidence of early safety parameters according to VARC-2 definitions
combined endpoint
incidence of combined efficacy according to VARC-2 definitions
combined endpoint
incidence of combined efficacy according to VARC-2 definitions
combined endpoint
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02668484
Brief Title
REpositionable Versus BallOOn-expandable Prosthesis for Trans-catheter Aortic Valve Implantation
Acronym
REBOOT
Official Title
Randomized Comparison of Repositionable and Balloon-Expandable Prostheses in Patients Undergoing Trans-catheter Aortic Valve Implantation
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
LMU Klinikum
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Disease
Keywords
TAVI, trans-femoral, Sapien, Lotus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
116 (Actual)
8. Arms, Groups, and Interventions
Arm Title
repositionable valve prosthesis
Arm Type
Experimental
Arm Description
Lotus
Arm Title
balloon-expandable valve prosthesis
Arm Type
Active Comparator
Arm Description
Sapien
Intervention Type
Device
Intervention Name(s)
repositionable valve prosthesis
Other Intervention Name(s)
Lotus
Intervention Description
repositionable valve prosthesis implanted via trans-femoral and trans-catheter route
Intervention Type
Device
Intervention Name(s)
balloon-expandable valve prosthesis
Other Intervention Name(s)
Sapien
Intervention Description
balloon-expandable valve prosthesis implanted via trans-femoral and trans-catheter route
Primary Outcome Measure Information:
Title
Incidence of new permanent pacemaker implantation
Description
implantation of PM
Time Frame
30 days
Secondary Outcome Measure Information:
Title
incidence of any prosthesis regurgitation
Description
prosthesis regurgitation in echocardiography
Time Frame
30 days
Title
Incidence of any conduction abnormalities
Description
conduction abnormalities on rest ECG
Time Frame
30 days
Title
Device success rate according to VARC-2 definition
Description
combined endpoint
Time Frame
30 days
Title
Mortality rate
Description
all-cause death
Time Frame
30 days
Title
Mortality rate
Description
all-cause death
Time Frame
1 year
Title
Mortality rate
Description
all-cause death
Time Frame
2 years
Title
incidence of early safety parameters according to VARC-2 definitions
Description
combined endpoint
Time Frame
30 days
Title
incidence of combined efficacy according to VARC-2 definitions
Description
combined endpoint
Time Frame
1 year
Title
incidence of combined efficacy according to VARC-2 definitions
Description
combined endpoint
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julinda Mehilli, MD
Organizational Affiliation
Munich University Clinic, Ludwig-Maximilians University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Munich University Clinic, Ludwig-Maximilians University
City
Munich
State/Province
Bavaria
ZIP/Postal Code
81377
Country
Germany
Facility Name
Segeberger Kliniken Gmbh
City
Bad Segeberg
State/Province
Schleswig Holstein
ZIP/Postal Code
23795
Country
Germany
Facility Name
Azienda Ospedaliero-Universitaria Pisana
City
Pisa
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
REpositionable Versus BallOOn-expandable Prosthesis for Trans-catheter Aortic Valve Implantation
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