LEADLESS II

• Research type

  Research Study

• Full title

  The Leadless II Study – Phase 2

• IRAS ID

  282749

• Contact name

  Tom Wong

• Contact email

  tom.wong@ic.ac.uk

• Sponsor organisation

  Abbott

• Clinicaltrials.gov Identifier

  NCT02030418

• Duration of Study in the UK

  1 years, 11 months, 31 days

• Research summary

  Research Summary

  The purpose of this study is to evaluate the safety and effectiveness of the leadless pacemaker system (“leadless pacemaker”) in treating patients with a slow heart rate or irregular heartbeats. The study is intended to contribute to CE marking and other regulatory pre-market submissions.

  The Leadless Pacemaker (LP) System aims to eliminate leads, pockets, and connectors required by conventional pacemakers and their associated complications. This system may improve patient comfort by replacing a surgical procedure with a percutaneous one, eliminating the visible lump and scar at a conventional pacemaker’s pectoral implant site, and removing the need for activity restrictions to prevent dislodgement after implantation of a conventional lead. This system could also permit pacemaker patients to undergo magnetic resonance imaging (MRI) with specified machines.

  Patients will be invited to receive the pre-CE marked device, Aveir, if they are indicated for a leadless VVI(R) pacemaker and meet the eligibility criteria in the protocol.

  Participants will be followed up following the Implant, pre-discharge, 2 and 6 week visit, 3, 6, and 12 months and then every 6 months until the study is finished (for up to two years). Participants will complete questionnaires. Medical History/ Patient status, Aveir LP device assessment and programming, Healthcare utilisation and follow up data will be collected as per protocol.

  A maximum of 615 patients worldwide will be enrolled in the Leadless IDE Phase 2 study at up to 80 centres. 60 investigational centres will be in the United States, 7 sites in Canada, 3 in Australia, and up to 10 sites in Europe.

  Lay summary of study results:

  Abbott received CE Mark certification of the AVEIR™ VR Leadless Pacemaker System on 21 July 2023.
  
  URL to summary results: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fclinicaltrials.gov%252Fstudy%252FNCT04559945%253Ftab%253Dhistory%2526a%253D11%2523version-content-panel%2FNBTI%2FvCK3AQ%2FAQ%2F623f5984-d402-444d-a14f-588114466200%2F1%2FWWnLC4d31T%23version-content-panel&data=05%7C02%7Csouthbirmingham.rec%40hra.nhs.uk%7C0c553cc242d74ee4138608dcb550a84f%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638584605236312702%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=l%2Bzw8H1Fzakhau9416UG2pjNlBkoWLTuHGGulwozlrk%3D&reserved=0

• REC name

  West Midlands - South Birmingham Research Ethics Committee

• REC reference

  20/WM/0301

• Date of REC Opinion

  20 Jan 2021

• REC opinion

  Further Information Favourable Opinion