Coronary DiseaseNCT04372654
Pilot Study Evaluating the Safety of Electroducer Sleeve Medical Device for Temporary Cardiac Stimulation During Percutaneous Cardiovascular Interventions, in All Kind of Patients
A study testing Electroducer Sleeve in people with Coronary Disease and Valve Heart Disease, run by Electroducer at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Coronary Disease, Valve Heart Disease, Pacemaker DDD
- What is being tested?
- Electroducer Sleeve
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 28 Jul 2020to 22 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Coronary Disease, Valve Heart Disease, Pacemaker DDD
- Being tested
- Electroducer Sleeve
- Medical subject headings
- Coronary Disease, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electroducer SleeveDevice
The device's safety will be assessed at the radial and femoral puncture site
| Study group | Role | What they receive |
|---|---|---|
| Radial group | Experimental | Use of Electroducer Sleeve on radial route Receives: Device: Electroducer Sleeve |
| femoral group | Experimental | Use of Electroducer Sleeve on femoral route Receives: Device: Electroducer Sleeve |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: during intervention
Secondary outcomes (7)
To evaluate the occurrence of Radial Artery Occlusion
RAO evaluated by a radial artery Doppler and by a reverse Allen test
Measured: at discharge and 1 month
To evaluate the occurrence of allergic or adverse tissue reactions
Outcome evaluated through the clinical examination of the puncture site.
Measured: at discharge and 1 month
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.
Measured: during intervention
To evaluate the performance of the ELECTRODUCER SLEEVE device
Performance evaluated through the stimulation threshold (mA) measured with the external pacemaker
Measured: during intervention
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
Measured: during intervention
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.
Measured: during intervention
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.
Measured: during intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2020
- Study start28 Jul 2020
- Primary completion25 Jan 2021
- Study completion22 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Pilot, prospective, multicenter, non-comparative study in 60 patients with a percutaneous cardiovascular intervention indication which requires temporary cardiac stimulation.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Electroducer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04372654
- Sponsor's protocol ID
- Electroducer study
- Status last verified
- Oct 2020
- First submitted
- 28 Apr 2020
- Last updated
- 1 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04372654
- Acronym / sponsor ID
- Electroducer study
- Conditions
- Coronary Disease, Valve Heart Disease, Pacemaker DDD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- ElectroducerIndustry (pharma, biotech, devices)
- Study start
- 28 Jul 2020 (actual)
- Primary completion
- 25 Jan 2021 (actual)
- Study completion
- 22 Feb 2021 (actual)
- First posted
- 4 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pilot, prospective, multicenter, non-comparative study in 60 patients with a percutaneous cardiovascular intervention indication which requires temporary cardiac stimulation.
| Arm | Type | Receives |
|---|---|---|
| Radial group | Experimental | Device: Electroducer SleeveUse of Electroducer Sleeve on radial route |
| femoral group | Experimental | Device: Electroducer SleeveUse of Electroducer Sleeve on femoral route |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electroducer SleeveThe device's safety will be assessed at the radial and femoral puncture site | Device | Radial group, femoral group |
Primary outcome
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).
7 secondary outcomes
To evaluate the occurrence of Radial Artery Occlusion
Time frame: at discharge and 1 month
To evaluate the occurrence of allergic or adverse tissue reactions
Time frame: at discharge and 1 month
To establish the efficacy of the ELECTRODUCER SLEEVE device
Time frame: during intervention
To evaluate the performance of the ELECTRODUCER SLEEVE device
Time frame: during intervention
To evaluate the impact of the ELECTRODUCER SLEEVE use on the TAVI procedure duration.
Time frame: during intervention
To evaluate the patient comfort with ELECTRODUCER SLEEVE use
Time frame: during intervention
To assess the user's overall impression of the ELECTRODUCER SLEEVE device and use.
Time frame: during intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroducer Sleeve in people with Coronary Disease and Valve Heart Disease, run by Electroducer at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2021.