Clinical trial NCT02668484: REpositionable Versus BallOOn-expandable Prosthesis for Trans-catheter Aortic Valve Implantation
Official title: Randomized Comparison of Repositionable and Balloon-Expandable Prostheses in Patients Undergoing Trans-catheter Aortic Valve Implantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Valve Disease
Keywords: TAVI
trans-femoral
Sapien
Lotus
Lead sponsor: LMU Klinikum
Sponsor class: OTHER
First posted: 2016-01-29
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of new permanent pacemaker implantation
timeFrame: 30 days
Secondary outcomes:
measure: incidence of any prosthesis regurgitation
timeFrame: 30 days
measure: Incidence of any conduction abnormalities
timeFrame: 30 days
measure: Device success rate according to VARC-2 definition
timeFrame: 30 days
measure: Mortality rate
timeFrame: 30 days
measure: Mortality rate
timeFrame: 1 year
measure: Mortality rate
timeFrame: 2 years
measure: incidence of early safety parameters according to VARC-2 definitions
timeFrame: 30 days
measure: incidence of combined efficacy according to VARC-2 definitions
timeFrame: 1 year
measure: incidence of combined efficacy according to VARC-2 definitions
timeFrame: 2 years
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Munich University Clinic, Ludwig-Maximilians University
state: Bavaria
city: Bad Segeberg
country: Germany
facility: Segeberger Kliniken Gmbh
state: Schleswig Holstein
city: Pisa
country: Italy
facility: Azienda Ospedaliero-Universitaria Pisana
Study officials:
affiliation: Munich University Clinic, Ludwig-Maximilians University
name: Julinda Mehilli, MD
role: PRINCIPAL_INVESTIGATOR
References: