Coronary Disease Clinical Trial
Official title:
Pilot Study Evaluating the Safety of Electroducer Sleeve Medical Device for Temporary Cardiac Stimulation During Percutaneous Cardiovascular Interventions, in All Kind of Patients
Verified date | October 2020 |
Source | Electroducer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | February 22, 2021 |
Est. primary completion date | January 25, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
France | GHMG | Grenoble |
Lead Sponsor | Collaborator |
---|---|
Electroducer |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 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). | during intervention | |
Secondary | To evaluate the occurrence of Radial Artery Occlusion | RAO evaluated by a radial artery Doppler and by a reverse Allen test | at discharge and 1 month | |
Secondary | To evaluate the occurrence of allergic or adverse tissue reactions | Outcome evaluated through the clinical examination of the puncture site. | at discharge and 1 month | |
Secondary | To establish the efficacy of the ELECTRODUCER SLEEVE device | Outcome evaluated through the capture in the surface electrocardiogram : each spike delivered on the guidewire is follow by its hemodynamic effect. | during intervention | |
Secondary | To evaluate the performance of the ELECTRODUCER SLEEVE device | Performance evaluated through the stimulation threshold (mA) measured with the external pacemaker | during intervention | |
Secondary | To evaluate the impact of the ELECTRODUCER SLEEVE use on the TAVI procedure duration. | Procedure duration is defined between the first vascular puncture and the last introducer removal and compared to the EASY TAVI study data | during intervention | |
Secondary | To evaluate the patient comfort with ELECTRODUCER SLEEVE use | 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. | during intervention | |
Secondary | To assess the user's overall impression of the ELECTRODUCER SLEEVE device and use. | Outcome evaluated by a satisfaction questionnaire developed by Electroducer, composed of four questions and a free comment section. | during intervention |
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