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

Not Applicable

Completed

• Conditions: Aortic Valve Disease
• Interventions: Device: balloon-expandable valve prosthesis; Device: repositionable valve prosthesis

• Registration Number: NCT02668484
• Lead Sponsor: LMU Klinikum

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.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-01-26
• Study First Submitted QC: 2016-01-26
• Study First Posted: 2016-01-29
• Primary Completion: 2017-05
• Status Verified: 2019-05
• Study Completion: 2019-05-31
• Last Update Submitted: 2019-05-31
• Last Update Posted: 2019-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
balloon-expandable valve prosthesis	balloon-expandable valve prosthesis	Sapien
repositionable valve prosthesis	repositionable valve prosthesis	Lotus

Primary Outcome Measures

Name	Time	Method
Incidence of new permanent pacemaker implantation	30 days	implantation of PM

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Segeberger Kliniken Gmbh; 🇩🇪 Bad Segeberg, Schleswig Holstein, Germany

Azienda Ospedaliero-Universitaria Pisana; 🇮🇹 Pisa, Italy

Munich University Clinic, Ludwig-Maximilians University; 🇩🇪 Munich, Bavaria, Germany