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Completed

NCT Number: NCT02781896

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

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.

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Key information

Conditions

Aortic Valve Stenosis Aortic Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Clermont Ferrand, Clermont-Ferrand, Auvergne-Rhône-Alpes, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pacing catheter

Device

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.

Other names: transvenous stimulation electrode, pacing lead, pacing wire

valve delivery guidewire

Device

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).

Primary outcomes

  1. Total TAVI procedural duration

    Time frame: 1 month

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

Secondary outcomes

  1. Efficacy of the experimental technique to create a blood pressure drop reaching at least 60 mmHg (Ventricular stimulation efficiency)

    Time frame: 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.

  2. Incidence of the experimental technique on succes rate of the intervention, fluoroscopy time, radiation exposure, Major adverse cardiovascular event and tamponades (Safety)

    Time frame: 1 month

    Safety includes success of the intervention, fluoroscopy time, radiation exposure, Major adverse cardiovascular event and tamponades

  3. Incidence of the experimental technique on direct and indirect costs (Cost-effectiveness)

    Time frame: 1 month

    Study costs includes direct costs (material used for the rapid pacing) and indirect costs (medical complications)

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier Mutualiste de Grenoble

Other

Collaborators

  • Centre Recherche Cardio Vasculaire Alpes

Registry information

Official study title

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

Acronym: EASY TAVI

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 25, 2016
Registry last updated
Jul 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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