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

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Brief Title

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

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 Type

Interventional

Primary Outcome

Total TAVI procedural duration

Secondary Outcome

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

Condition

Aortic Valve Stenosis

Intervention

pacing catheter

Study Arms / Comparison Groups

 Right ventricular pacing
Description:  Rapid pacing during TAVI is provided by a temporary pacing catheter placed in the right ventricle. An additional venous vascular access is required.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Device

Estimated Enrollment

300

Start Date

May 12, 2017

Completion Date

June 29, 2018

Primary Completion Date

June 29, 2018

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

Gender

All

Ages

18 Years - 100 Years

Accepts Healthy Volunteers

No

Contacts

Benjamin Faurie, ,

Location Countries

France

Location Countries

France

Administrative Informations

NCT ID

NCT02781896

Organization ID

EASY TAVI 2016

Responsible Party

Sponsor

Study Sponsor

Groupe Hospitalier Mutualiste de Grenoble

Collaborators

 Centre Recherche Cardio Vasculaire Alpes

Study Sponsor

Benjamin Faurie, Principal Investigator, Centre Recherche Cardio Vasculaire Alpes

Verification Date

July 2018