Pilot Study Evaluating the Safety of Electroducer Sleeve Medical Device for Temporary Cardiac Stimulation During Percutaneous Cardiovascular Interventions, in All Kind of Patients
Condition: Coronary Disease; Valve Heart Disease; Pacemaker DDD
MeSH terms: Heart Diseases; Coronary Disease; Heart Valve Diseases
Study type: Interventional

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.
    

Intervention name(s): Electroducer Sleeve
Intervention type(s): Device
Intervention description(s): The device's safety will be assessed at the radial and femoral puncture site
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention 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)
Primary purpose: Other