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

Groupe Hospitalier Mutualiste de Grenoble

Status: Completed

Conditions: Aortic Valve Stenosis

Treatments: Device: pacing catheter; Device: valve delivery guidewire

Study type: Interventional

Funder types: Other

Identifiers

NCT02781896

EASY TAVI 2016

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 300 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 2 patient groups

Right ventricular pacing

Active Comparator group

Description:

Rapid pacing during TAVI is provided by a temporary pacing catheter placed in the right ventricle. An additional venous vascular access is required.

Treatment:

Device: pacing catheter

Left ventricular pacing

Experimental group

Description:

Rapid pacing during TAVI is provided by the valve delivery guidewire inserted into the left ventricle using two alligator clamps. One clamp is attached directly to the skin at the femoral entry site, the other is attached to the body of the valve delivery guidewire. No additional venous vascular access is required.

Treatment:

Device: valve delivery guidewire