Direct Left Ventricular Rapid Pacing Via the Valve Delivery Guide-wire in TAVI

Direct Left Ventricular Rapid Pacing Via the Valve Delivery Guide-wire in TAVI: a Randomized Study

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.

Inclusion Criteria:

• Subject is eligible for a TAVI
• Access considered for aortic valve bioprothesis delivery is transfemoral
• Aortic valve bioprothesis considered is Edwards Sapien 3® et/ou XT®
• Subject is ≥ 18 years of age
• Subject has signed informed consent form

Exclusion Criteria:

• Pregnancy
• Subject already included in this study
• Subject included in another study and whose inclusion in EASY TAVI implies a deviation in either study