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