The Leadless II Study – Phase 2
Duration of Study in the UK
1 years, 11 months, 31 days
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.
West Midlands - South Birmingham Research Ethics Committee
Date of REC Opinion
20 Jan 2021
Further Information Favourable Opinion