REpositionable Versus BallOOn-expandable Prosthesis for Trans-catheter Aortic Valve Implantation

Aortic Valve Disease Clinical Trial

— REBOOT  

Official title:

Randomized Comparison of Repositionable and Balloon-Expandable Prostheses in Patients Undergoing Trans-catheter Aortic Valve Implantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02668484
• Other study ID #: GEMucS001-15
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: May 31, 2019

Study information

• Verified date: May 2019
• Source: Klinikum der Universitaet Muenchen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: May 31, 2019
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Symptomatic aortic valve disease in need of valve replacement

2. Heart team (including at least a cardiac surgeon and an interventional cardiologist) agrees on the eligibility that trans-femoral TAVI is appropriate.

3. Study patient is an adult of legal consent age.

4. Study patient has provided written informed consent to participate in the study

Exclusion Criteria:

1. Life expectancy < 12 months due to co-morbid conditions.

2. Native aortic valve annulus size and morphology not suitable for Lotus or Sapien prosthesis implantation

3. Preexisting bioprosthetic valve or ring in aortic valve position.

4. Pre-existing pacemaker or ICD/CRT.

5. Cardiogenic shock or hemodynamic instability.

6. History of active endocarditis

7. Contraindications for a trans-femoral access.

8. Severe left ventricular dysfunction with LVEF <30%.

9. Severe mitral valve insufficiency.

10. Echocardiographic evidence of intracardiac mass, thrombus or vegetation.

11. Patients actively participating in another drug or device investigational study and have not yet completed the primary endpoint follow-up period.

12. Patients suffering from dementia.

13. Pregnant or nursing women

Related Conditions & MeSH terms

• Aortic Valve Disease

Intervention

Device:
• repositionable valve prosthesis
repositionable valve prosthesis implanted via trans-femoral and trans-catheter route
• balloon-expandable valve prosthesis
balloon-expandable valve prosthesis implanted via trans-femoral and trans-catheter route

Locations

Country	Name	City	State
Germany	Segeberger Kliniken Gmbh	Bad Segeberg	Schleswig Holstein
Germany	Munich University Clinic, Ludwig-Maximilians University	Munich	Bavaria
Italy	Azienda Ospedaliero-Universitaria Pisana	Pisa

Sponsors (1)

Lead Sponsor	Collaborator
Klinikum der Universitaet Muenchen

Countries where clinical trial is conducted

Germany,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of new permanent pacemaker implantation	implantation of PM	30 days
Secondary	incidence of any prosthesis regurgitation	prosthesis regurgitation in echocardiography	30 days
Secondary	Incidence of any conduction abnormalities	conduction abnormalities on rest ECG	30 days
Secondary	Device success rate according to VARC-2 definition	combined endpoint	30 days
Secondary	Mortality rate	all-cause death	30 days
Secondary	Mortality rate	all-cause death	1 year
Secondary	Mortality rate	all-cause death	2 years
Secondary	incidence of early safety parameters according to VARC-2 definitions	combined endpoint	30 days
Secondary	incidence of combined efficacy according to VARC-2 definitions	combined endpoint	1 year
Secondary	incidence of combined efficacy according to VARC-2 definitions	combined endpoint	2 years