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

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.

Study Overview

• Status: Completed
• Conditions: Aortic Valve Disease
• Intervention / Treatment: Device: repositionable valve prosthesis; Device: balloon-expandable valve prosthesis

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 Type: Interventional
• Enrollment (Actual): 116
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bavaria
    • Munich, Bavaria, Germany, 81377
      • Munich University Clinic, Ludwig-Maximilians University
  • Schleswig Holstein
    • Bad Segeberg, Schleswig Holstein, Germany, 23795
      • Segeberger Kliniken Gmbh
• Italy
  • Pisa, Italy
    • Azienda Ospedaliero-Universitaria Pisana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: repositionable valve prosthesis; Lotus	Device: repositionable valve prosthesis; repositionable valve prosthesis implanted via trans-femoral and trans-catheter route; Other Names: Lotus
Active Comparator: balloon-expandable valve prosthesis; Sapien	Device: balloon-expandable valve prosthesis; balloon-expandable valve prosthesis implanted via trans-femoral and trans-catheter route; Other Names: Sapien

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of new permanent pacemaker implantation	implantation of PM	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of any prosthesis regurgitation	prosthesis regurgitation in echocardiography	30 days
Incidence of any conduction abnormalities	conduction abnormalities on rest ECG	30 days
Device success rate according to VARC-2 definition	combined endpoint	30 days
Mortality rate	all-cause death	30 days
Mortality rate	all-cause death	1 year
Mortality rate	all-cause death	2 years
incidence of early safety parameters according to VARC-2 definitions	combined endpoint	30 days
incidence of combined efficacy according to VARC-2 definitions	combined endpoint	1 year
incidence of combined efficacy according to VARC-2 definitions	combined endpoint	2 years

Collaborators and Investigators

• Sponsor: LMU Klinikum
• Investigators: Principal Investigator: Julinda Mehilli, MD, Munich University Clinic, Ludwig-Maximilians University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): May 31, 2019

Study Registration Dates

• First Submitted: January 26, 2016
• First Submitted That Met QC Criteria: January 26, 2016
• First Posted (Estimate): January 29, 2016

Study Record Updates

• Last Update Posted (Actual): June 3, 2019
• Last Update Submitted That Met QC Criteria: May 31, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: TAVI; Lotus; trans-femoral; Sapien
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Aortic Valve Disease
• Other Study ID Numbers: GEMucS001-15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO