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

Groupe Hospitalier Mutualiste de Grenoble300 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

300

Conditions

Aortic Valve Stenosis

Interventions

pacing catheterDEVICE

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.

valve delivery guidewireDEVICE

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).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Locations (9)

CHU Clermont Ferrand

Clermont-Ferrand, Auvergne-Rhône-Alpes, France

Centre Hospitalier Annecy Genevois

Épagny, Auvergne-Rhône-Alpes, France

Clinique du Tonkin

Villeurbanne, Auvergne-Rhône-Alpes, France

Groupement Hospitalier Mutualiste de Grenoble

Outcomes

Primary Outcomes

Total TAVI procedural duration

Duration of TAVI procedure is calculated from the first puncture to the last sheath removal

Time frame: 1 month

Secondary Outcomes

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.

Time frame: 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

Time frame: 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)

Time frame: 1 month

Data from ClinicalTrials.gov

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