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

NACompletedINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

May 12, 2017

Primary Completion Date

June 29, 2018

Study Completion Date

June 29, 2018

Conditions
Aortic Valve Stenosis
Interventions
DEVICE

pacing catheter

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.

DEVICE

valve delivery guidewire

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).

Trial Locations (9)

31300

Clinique Pasteur, Toulouse

38028

Groupement Hospitalier Mutualiste de Grenoble, Grenoble

63000

CHU Clermont Ferrand, Clermont-Ferrand

69100

Clinique du Tonkin, Villeurbanne

74370

Centre Hospitalier Annecy Genevois, Épagny

75014

Institut Mutualiste Montsouris, Paris

76000

Clinique Saint-Hilaire, Rouen

91300

Hôpital privé Jacques Cartier, Paris

06721

Institut Arnault Tzanck, Saint-Laurent-du-Var

All Listed Sponsors
collaborator

Centre Recherche Cardio Vasculaire Alpes

OTHER

lead

Groupe Hospitalier Mutualiste de Grenoble

OTHER

NCT02781896 - Direct Left Ventricular Rapid Pacing Via the Valve Delivery Guide-wire in TAVI | Biotech Hunter | Biotech Hunter