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

NCT02781896 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2018-07-12

No results posted yet for this study

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.

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).

Sponsors & Collaborators

  • Centre Recherche Cardio Vasculaire Alpes

    collaborator OTHER

  • Groupe Hospitalier Mutualiste de Grenoble

    lead OTHER

Principal Investigators

  • Benjamin Faurie · Centre Recherche Cardio Vasculaire Alpes

  • Thierry Lefèvre · Massy

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-12
Primary Completion
2018-06-29
Completion
2018-06-29

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02781896 on ClinicalTrials.gov