AVEIR DR i2i Study
“AveirTM DR i2i Study” Aveir Dual-Chamber Leadless i2i IDE Study
Duration of Study in the UK
1 years, 11 months, 2 days
This research study is to evaluate the safety and effectiveness of the Aveir Dual-Chamber leadless pacemaker system (“leadless pacemaker system”) 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.
Participants are invited to receive the device if they are indicated for a Pacemaker and meet the study eligibility criteria.
Participants receive follow up at Implant, Pre-Discharge, 1-Month post discharge, 3-Months, 6-Months and 12-Months. After 12 months, follow-up is scheduled every 6 months until the study is finished.
Pre-Discharge, all participants will have a Chest X-ray to check the position of the pacemakers, and an ECG. At 3-Month Visit, participants are asked to wear a Holter Monitor to assess coordination between the two pacemakers.
At all scheduled follow up visits, all participants will be asked of any cardiac medication taken daily and an assessment of the pacemaker system will be performed. The participant will also be asked to complete a questionnaire.
- Up to 30 patients enrolled in the study will be asked to complete a 6-minute walk assessment to be performed any time from 1-Month Visit to 3-Month Visit.
- Up to 30 patients enrolled in the study will be asked to walk on a treadmill to assess the pacemaker during exercise. This is to be performed any time from 1-Month to 3-Month Visit.
- Up to 50 patients enrolled in the study will be asked to wear a Holter monitor for 24 hours and record any symptoms they feel whilst wearing the monitor in a diary. This is to be performed any time from 3-Month to 6-Month Visit.
This Study will enroll up to 550 participants at up to 80 sites worldwide, including sites in the United States, Canada, Europe, and Asia-Pacific.
HSC REC B
Date of REC Opinion
12 Jan 2022
Further Information Favourable Opinion