The purpose of this study is to determine whether a left ventricular rapid pacing using the valve delivery guide-wire in transcatheter aortic valve implantation (TAVI) reduces the overall procedure duration in comparison with the conventional method.
Use of temporary pacing via a right ventricular lead in TAVI is still mandatory to ensure transient cardiac standstill while predilatation is performed and the valve is being positioned and deployed. This requires an additional venous vascular access and a pacing catheter which are both likely to generate complications.
This study compares the standard right ventricular rapid pacing to a new and simplified technique : a left ventricular rapid pacing is provided via the back-up 0.035 " guidewire. The cathode of an external pacemaker is placed on the tip of the 0.035" wire and the anode on a needle inserted into the groin. Insulation is ensured by the balloon or TAVI catheter.
ClinicalTrials.gov ID: NCT02781896
Sponsor
Groupe Hospitalier Mutualiste de Grenoble
Primary endpoints
Assess the impact of the ventricular pacing strategy on the total duration of a TAVI procedure
CERC Services
- Project management
- Safety reporting
- Monitoring activities
- CRF and Data management
- Clinical Events Committee (CEC) activities
- Statistical Analysis
- Final study report
Countries
France
Number of investigational sites
10
Number of patients
300
