Clinical trial NCT02781896: Direct Left Ventricular Rapid Pacing Via the Valve Delivery Guide-wire in TAVI
Official title: Direct Left Ventricular Rapid Pacing Via the Valve Delivery Guide-wire in TAVI: a Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Valve Stenosis
Keywords: TAVI
aortic valve bioprothesis
TAVI simplification
aortic stenosis
rapid left ventricular pacing
TAVR
Lead sponsor: Groupe Hospitalier Mutualiste de Grenoble
Sponsor class: OTHER
Collaborators: name: Centre Recherche Cardio Vasculaire Alpes
First posted: 2016-05-25
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Total TAVI procedural duration
timeFrame: 1 month
Secondary outcomes:
measure: Efficacy of the experimental technique to create a blood pressure drop reaching at least 60 mmHg (Ventricular stimulation efficiency)
timeFrame: 1 month
measure: Incidence of the experimental technique on succes rate of the intervention, fluoroscopy time, radiation exposure, Major adverse cardiovascular event and tamponades (Safety)
timeFrame: 1 month
measure: Incidence of the experimental technique on direct and indirect costs (Cost-effectiveness)
timeFrame: 1 month
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont Ferrand
state: Auvergne-Rhône-Alpes
city: Epagny
country: France
facility: Centre Hospitalier Annecy Genevois
state: Auvergne-Rhône-Alpes
city: Villeurbanne
country: France
facility: Clinique du Tonkin
state: Auvergne-Rhône-Alpes
city: Paris
country: France
facility: Institut Mutualiste Montsouris
state: Ile De France
city: Grenoble
country: France
facility: Groupement Hospitalier Mutualiste de Grenoble
state: Isère
city: Paris
country: France
facility: Hôpital privé Jacques Cartier
state: Massy
city: Rouen
country: France
facility: Clinique Saint-Hilaire
state: Normandie
city: Toulouse
country: France
facility: Clinique Pasteur
state: Occitanie
city: Saint-Laurent-du-Var
country: France
facility: Institut Arnault Tzanck
state: Provence-Alpes-Côte d'Azur
Study officials:
affiliation: Centre Recherche Cardio Vasculaire Alpes
name: Benjamin Faurie
role: PRINCIPAL_INVESTIGATOR
affiliation: Massy
name: Thierry Lefèvre
role: PRINCIPAL_INVESTIGATOR
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