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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Aortic Valve Stenosis

Intervention / Treatment
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* Device: pacing catheter
* Device: valve delivery guidewire


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Right ventricular pacing<br>Rapid pacing during TAVI is provided by a temporary pacing catheter placed in the right ventricle. An additional venous vascular access is required. | Device: pacing catheter<br>* Rapid pacing during TAVI is required to ensure transient cardiac standstill while predilatation is performed and the valve is being positioned and deployed. In the right ventricular pacing arm, rapid pacing is provided by a standard right ventricular pacing catheter.<br>* Other names: pacing wire;|
| Experimental: Left ventricular pacing<br>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. | Device: valve delivery guidewire<br>* Rapid pacing during TAVI is required to ensure transient cardiac standstill while predilatation is performed and the valve is being positioned and deployed. In the Left ventricular pacing arm, rapid pacing is provided via the valve-delivery guidewire inserted into the left ventricle. The cathode of an external pacemaker is placed on the external end of the guidewire using an alligator clamp. The TAVI catheter provides the necessary insulation. The anode is attached directly to the subcutaneous tissue at the femoral entry site (also using an alligator clamp).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total TAVI procedural duration | Duration of TAVI procedure is calculated from the first puncture to the last sheath removal | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of the experimental technique to create a blood pressure drop reaching at least 60 mmHg (Ventricular stimulation efficiency) | Stimulation efficiency is defined as a drop in systolic blood pressure reaching at least 60 mmHg during the prolonged stimulation without loss of capture for more than 30s. | 1 month | 
| Incidence of the experimental technique on succes rate of the intervention, fluoroscopy time, radiation exposure, Major adverse cardiovascular event and tamponades (Safety) | Safety includes success of the intervention, fluoroscopy time, radiation exposure, Major adverse cardiovascular event and tamponades | 1 month | 
| Incidence of the experimental technique on direct and indirect costs (Cost-effectiveness) | Study costs includes direct costs (material used for the rapid pacing) and indirect costs (medical complications) | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TAVI, aortic valve bioprothesis, TAVI simplification, aortic stenosis, rapid left ventricular pacing, TAVR