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

Not Applicable

Completed

• Conditions: Aortic Valve Stenosis
• Interventions: Device: valve delivery guidewire; Device: pacing catheter

• Registration Number: NCT02781896
• Lead Sponsor: Groupe Hospitalier Mutualiste de Grenoble

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.

Study Timeline

• Study First Submitted: 2016-05-18
• Study First Submitted QC: 2016-05-20
• Study First Posted: 2016-05-25
• Study Start: 2017-05-12
• Primary Completion: 2018-06-29
• Study Completion: 2018-06-29
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-11
• Last Update Posted: 2018-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Left ventricular pacing	valve delivery guidewire	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.
Right ventricular pacing	pacing catheter	Rapid pacing during TAVI is provided by a temporary pacing catheter placed in the right ventricle. An additional venous vascular access is required.

Primary Outcome Measures

Name	Time	Method
Total TAVI procedural duration	1 month	Duration of TAVI procedure is calculated from the first puncture to the last sheath removal

Secondary Outcome Measures

Name	Time	Method
Incidence of the experimental technique on succes rate of the intervention, fluoroscopy time, radiation exposure, Major adverse cardiovascular event and tamponades (Safety)	1 month	Safety includes success of the intervention, fluoroscopy time, radiation exposure, Major adverse cardiovascular event and tamponades
Incidence of the experimental technique on direct and indirect costs (Cost-effectiveness)	1 month	Study costs includes direct costs (material used for the rapid pacing) and indirect costs (medical complications)
Efficacy of the experimental technique to create a blood pressure drop reaching at least 60 mmHg (Ventricular stimulation efficiency)	1 month	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.

Trial Locations

Locations (9)

Clinique Saint-Hilaire; 🇫🇷 Rouen, Normandie, France

CHU Clermont Ferrand; 🇫🇷 Clermont-Ferrand, Auvergne-Rhône-Alpes, France

Centre Hospitalier Annecy Genevois; 🇫🇷 Epagny, Auvergne-Rhône-Alpes, France

Hôpital privé Jacques Cartier; 🇫🇷 Paris, Massy, France

Institut Mutualiste Montsouris; 🇫🇷 Paris, Ile De France, France

Institut Arnault Tzanck; 🇫🇷 Saint-Laurent-du-Var, Provence-Alpes-Côte d'Azur, France

Groupement Hospitalier Mutualiste de Grenoble; 🇫🇷 Grenoble, Isère, France

Clinique Pasteur; 🇫🇷 Toulouse, Occitanie, France

Clinique du Tonkin; 🇫🇷 Villeurbanne, Auvergne-Rhône-Alpes, France