Coronary Disease, Pacemaker DDD, Valve Heart Disease
Conditions
Brief summary
During percutaneous cardiovascular intervention, temporary cardiac stimulation may be required. Usually this stimulation is generated via a temporary pacing catheter. In order to reduce the complexity of the procedure, a new stimulation strategy has been developed: the Direct Wire Pacing technique.In this approach, the cardiac stimulation is provided via the guidewire connected to an external pacemaker. Previous study demonstrated the superiority of the new technique compared to the former. However this technique is likely to generate electrical pain, risk of bleeding for the patient and risk of blood exposure accident for the operators. This is why the medical device ELECTRODUCER SLEEVE has been developed. This device integrates a pacing function to the introducer and the guidewire used. The Direct Wire Pacing technique is simplified, secured and more reproducible.
Detailed description
During percutaneous cardiovascular interventions such as Transcatheter Heart Valve or coronary intervention, temporary cardiac stimulation may be required. Usually this stimulation is generated via a temporary pacing catheter in the right ventricle. This procedure requires an additional venous access and the insertion of the stimulation catheter, which are both likely to generate complications. In order to reduce the complexity and increase the safety of the procedure, a new stimulation strategy has been developed: the Direct Wire Pacing technique. In this approach, the specific venous access and the implantation of a stimulation catheter are avoided. The cardiac stimulation is provided via the guidewire inserted into the left ventricle or into the coronary arteries. This guidewire is connected to an external Pacemaker using an alligator clamp (Cathode). The Pacemaker anode is also connected using a clamp attached to a needle piercing the subcutaneous tissue, obtaining a closed electrical circuit. This technique was validated during previous studies in the TAVI context through two registries and one randomized controlled trial. This study demonstrated the superiority of the new technique by showing a reduction of the procedural duration, radiation exposure and costs; with similar efficacy and safety. However the subcutaneous needle insertion is likely to generate electrical pain, risk of bleeding for the patient and risk of blood exposure accident for the operators. This subcutaneous anode increases the stimulation threshold (mA) which can cause stimulation failures. Moreover, several technical difficulties preclude general adoption by the scientific community. This is why the medical device ELECTRODUCER SLEEVE has been developed. This device integrates a pacing function to the introducer and the guidewire used during percutaneous cardiovascular interventions. The guidewire then behaves like an intra-cardiac cathode. Thanks to the device, the complex manipulation of needles and clamps during the intervention are avoided as well as pole inversions. The Direct Wire Pacing technique used during the coronary and structural interventions is thus simplified, secured and more reproducible.
Interventions
DEVICEElectroducer Sleeve
The device's safety will be assessed at the radial and femoral puncture site
Sponsors
Electroducer
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Pilot, prospective, multicenter, non-comparative study in 60 patients with a percutaneous cardiovascular intervention indication which requires temporary cardiac stimulation.
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Patients ≥ 18 years old * Patients with a percutaneous cardiovascular intervention indication, requiring temporary cardiac stimulation * Procedure carried out with a 6Fr TERUMO introducer ≥ 65 mm * Procedure performed by femoral or radial routes * Patients able to understand and provide informed consent * Patients able to perform the planned follow-up visit one month after the procedure.
Exclusion criteria
* Patients requiring a definitive PM * Pregnant or breastfeeding woman * Patiens under judicial protection, tutorship or curatorship * Negative Allen test or absence of radial pulse in the artery or vein used for intervention * Patient participating in another interventional clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess the peri procedural safety of ELECTRODUCER SLEEVE device used for temporary cardiac pacing during percutaneous cardiovascular interventions, by radial and femoral routes of access. | during intervention | The device safety is assessed through the occurrence of bleeding complications at the access site where the ELECTRODUCER SLEEVE was used, including: Hematoma formation (EASY Classification) and Access-site Bleeding (BARC classification). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the occurrence of allergic or adverse tissue reactions | at discharge and 1 month | Outcome evaluated through the clinical examination of the puncture site. |
| To establish the efficacy of the ELECTRODUCER SLEEVE device | during intervention | Outcome evaluated through the capture in the surface electrocardiogram : each spike delivered on the guidewire is follow by its hemodynamic effect. |
| To evaluate the performance of the ELECTRODUCER SLEEVE device | during intervention | Performance evaluated through the stimulation threshold (mA) measured with the external pacemaker |
| To evaluate the occurrence of Radial Artery Occlusion | at discharge and 1 month | RAO evaluated by a radial artery Doppler and by a reverse Allen test |
| To evaluate the patient comfort with ELECTRODUCER SLEEVE use | during intervention | Confort evaluated using the Echelle Visuelle Analogique de la douleur from 0 to 10: 0 being the absence of pain and 10 being unbearable pain. |
| To assess the user's overall impression of the ELECTRODUCER SLEEVE device and use. | during intervention | Outcome evaluated by a satisfaction questionnaire developed by Electroducer, composed of four questions and a free comment section. |
| To evaluate the impact of the ELECTRODUCER SLEEVE use on the TAVI procedure duration. | during intervention | Procedure duration is defined between the first vascular puncture and the last introducer removal and compared to the EASY TAVI study data |
Countries
France
Outcome results
None listed