Aortic Valve Stenosis
Conditions
Keywords
TAVI, aortic valve bioprothesis, TAVI simplification, aortic stenosis, rapid left ventricular pacing, TAVR
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.
Interventions
DEVICEpacing 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.
DEVICEvalve 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
Centre Recherche Cardio Vasculaire Alpes
Groupe Hospitalier Mutualiste de Grenoble
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total TAVI procedural duration | 1 month | Duration of TAVI procedure is calculated from the first puncture to the last sheath removal |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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) |
Countries
France
Outcome results
None listed