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

NCT04372654 | Completed

• 1 other identifier: Electroducer study
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Disease; Valve Heart Disease; Pacemaker DDD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• To evaluate the occurrence of Radial Artery Occlusion

  at discharge and 1 month

• To evaluate the occurrence of allergic or adverse tissue reactions

  at discharge and 1 month

• To establish the efficacy of the ELECTRODUCER SLEEVE device

  during intervention

• To evaluate the performance of the ELECTRODUCER SLEEVE device

  during intervention

• To evaluate the impact of the ELECTRODUCER SLEEVE use on the TAVI procedure duration.

  during intervention

Study Arms (2)

Radial group

EXPERIMENTAL

Use of Electroducer Sleeve on radial route

Device: Electroducer Sleeve

femoral group

EXPERIMENTAL

Use of Electroducer Sleeve on femoral route

Device: Electroducer Sleeve

Interventions

Electroducer Sleeve DEVICE

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

Radial group; femoral group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Electroducer: lead

Study Sites (1)

GHMG

Grenoble, France

Location

MeSH Terms

Conditions

Coronary Disease; Heart Valve Diseases

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Pilot, prospective, multicenter, non-comparative study in 60 patients with a percutaneous cardiovascular intervention indication which requires temporary cardiac stimulation.

Study Record Dates

• First Submitted: April 28, 2020
• First Posted: May 4, 2020
• Study Start: July 28, 2020
• Primary Completion: January 25, 2021
• Study Completion: February 22, 2021
• Last Updated: March 1, 2021

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)