- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04372654
Pilot Study Evaluating the Safety of Electroducer Sleeve Medical Device for Temporary Cardiac Stimulation During Percutaneous Cardiovascular Interventions, in All Kind of Patients
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Grenoble, France
- GHMG
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Radial group
Use of Electroducer Sleeve on radial route
|
The device's safety will be assessed at the radial and femoral puncture site
|
EXPERIMENTAL: femoral group
Use of Electroducer Sleeve on femoral route
|
The device's safety will be assessed at the radial and femoral puncture site
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
Time Frame: 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).
|
during intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To evaluate the occurrence of Radial Artery Occlusion
Time Frame: at discharge and 1 month
|
RAO evaluated by a radial artery Doppler and by a reverse Allen test
|
at discharge and 1 month
|
To evaluate the occurrence of allergic or adverse tissue reactions
Time Frame: at discharge and 1 month
|
Outcome evaluated through the clinical examination of the puncture site.
|
at discharge and 1 month
|
To establish the efficacy of the ELECTRODUCER SLEEVE device
Time Frame: during intervention
|
Outcome evaluated through the capture in the surface electrocardiogram : each spike delivered on the guidewire is follow by its hemodynamic effect.
|
during intervention
|
To evaluate the performance of the ELECTRODUCER SLEEVE device
Time Frame: during intervention
|
Performance evaluated through the stimulation threshold (mA) measured with the external pacemaker
|
during intervention
|
To evaluate the impact of the ELECTRODUCER SLEEVE use on the TAVI procedure duration.
Time Frame: during intervention
|
Procedure duration is defined between the first vascular puncture and the last introducer removal and compared to the EASY TAVI study data
|
during intervention
|
To evaluate the patient comfort with ELECTRODUCER SLEEVE use
Time Frame: 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.
|
during intervention
|
To assess the user's overall impression of the ELECTRODUCER SLEEVE device and use.
Time Frame: during intervention
|
Outcome evaluated by a satisfaction questionnaire developed by Electroducer, composed of four questions and a free comment section.
|
during intervention
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Electroducer study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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