WAVECREST PMCF STUDY - CHX_IP015

• Research type

  Research Study

• Full title

  A PROSPECTIVE, MULTICENTER, NON-RANDOMIZED, POST-MARKET CLINICAL FOLLOW-UP STUDY TO CONFIRM SAFETY AND PERFORMANCE OF THE COHEREX WAVECREST® LEFT ATRIAL APPENDAGE OCCLUSION SYSTEM IN CURRENT MEDICAL PRACTICE IN PATIENTS WITH NON-VALVULAR ATRIAL FIBRILLATION WAVECREST PMCF STUDY - CHX_IP015

• IRAS ID

  231907

• Contact name

  David John Ryvet HILDICK-SMITH

• Contact email

  david.hildick-smith@bsuh.nhs.uk

• Sponsor organisation

  Coherex Medical

• Clinicaltrials.gov Identifier

  NCT03204695

• Duration of Study in the UK

  0 years, 6 months, days

• Research summary

  Research Summary

  This is a post-market, prospective, non-randomized standard of care, clinical follow-up study (PMCF) designed to confirm safety and performance of the WaveCrest Left Atrial Appendage Occlusion System following its CE-mark approval, in patients with non-valvular atrial fibrillation who are at increased risk of stroke. The device will be used within the approved CE-mark indication and no additional tests or data will be collected other than those included in standard medical practice. Up to 65 patients will be included in the study in up to 15 hospitals in Europe, of which up to 8 in each of the two UK sites.
  The purpose of this study is to confirm the safety and effectiveness of the WaveCrest device in treating patients who have atrial fibrillation (an abnormal heart rhythm) and are at increased risk of stroke. The device is permanently implanted to close the left atrial appendix (LAA), a pocket in the heart. After the implant, patients will be followed for 45 days after the implant procedure.

  Summary of Results

  The WaveCrest PMCF study was designed to confirm safety and performance of the WaveCrest device following minor system enhancements in current medical practice in patients with non-valvular atrial fibrillation.
  The study was put on enrollment hold in May 2018 and enrollment never resumed. In August 2022 decision was made to prematurely terminate the study.
  The study was initially designed to include 65 subjects, however, the study was prematurely closed when 27 subjects were enrolled.

• REC name

  London - Brighton & Sussex Research Ethics Committee

• REC reference

  17/LO/2058

• Date of REC Opinion

  8 Jan 2018

• REC opinion

  Further Information Favourable Opinion