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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Disease
Valve Heart Disease
Pacemaker DDD
Lead sponsor: Electroducer
Sponsor class: INDUSTRY
First posted: 2020-05-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pilot, prospective, multicenter, non-comparative study in 60 patients with a percutaneous cardiovascular intervention indication which requires temporary cardiac stimulation.
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
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.
timeFrame: during intervention
Secondary outcomes:
measure: To evaluate the occurrence of Radial Artery Occlusion
timeFrame: at discharge and 1 month
measure: To evaluate the occurrence of allergic or adverse tissue reactions
timeFrame: at discharge and 1 month
measure: To establish the efficacy of the ELECTRODUCER SLEEVE device
timeFrame: during intervention
measure: To evaluate the performance of the ELECTRODUCER SLEEVE device
timeFrame: during intervention
measure: To evaluate the impact of the ELECTRODUCER SLEEVE use on the TAVI procedure duration.
timeFrame: during intervention
measure: To evaluate the patient comfort with ELECTRODUCER SLEEVE use
timeFrame: during intervention
measure: To assess the user's overall impression of the ELECTRODUCER SLEEVE device and use.
timeFrame: during intervention
Other outcomes:
Locations:
city: Grenoble
country: France
facility: GHMG
Study officials:
References: