RESDIO AP

Phase Device

GLCC Activities

  • Project Management
  • Regulatory Submissions
  • Site Management
  • Monitoring
  • Randomisation
  • Data Management

RESDIO AP

  • 300 participants
  • 4 sites in New Zealand
  • 1 site in Australia

Randomised Controlled Trial Evaluating Safety of Device Implantation in Orally Anticoagulated Patients (RESDIO-AP trial).

A randomised, single-blinded, controlled trial comparing device implantation in patients with therapeutic levels of anticoagulation (INR 2.0-3.0) to those with an INR <1.5 at the time of the surgical procedure.

This is a randomised, single blinded, controlled trial comparing device implantation in participants with therapeutic levels of anticoagulation (INR 2.0-3.0) to those with an INR <1.5 at the time of the surgical procedure. The purpose of this study is to prospectively evaluate the safety and efficacy of device implantation in patients with therapeutic levels of anticoagulation (INR 2.0-3.0) in a multi-centre randomised controlled trial. The study is to be conducted at 5 centres located in NZ and Australia.