Pilot Study Evaluating the Safety of Electroducer Sleeve Medical Device for Temporary Cardiac Stimulation During Percutaneous Cardiovascular Interventions, in All Kind of Patients

NCT ID: NCT04372654

Last Updated: 2021-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-28
• Study Completion Date: 2021-02-22

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.

Conditions

Coronary Disease; Valve Heart Disease; Pacemaker DDD

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Radial group

Use of Electroducer Sleeve on radial route

Group Type: EXPERIMENTAL

Electroducer Sleeve

Intervention Type: DEVICE

The device's safety will be assessed at the radial and femoral puncture site

femoral group

Use of Electroducer Sleeve on femoral route

Group Type: EXPERIMENTAL

Electroducer Sleeve

Intervention Type: DEVICE

The device's safety will be assessed at the radial and femoral puncture site

Interventions

Electroducer Sleeve

The device's safety will be assessed at the radial and femoral puncture site

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Electroducer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

GHMG

Grenoble, , France

Countries

France

Other Identifiers

Electroducer study

Identifier Type: -

Identifier Source: org_study_id