AVEIR DR i2i Study
Research type
Research Study
Full title
“AveirTM DR i2i Study” Aveir Dual-Chamber Leadless i2i IDE Study
IRAS ID
308539
Contact name
Tom Wong
Contact email
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 11 months, 2 days
Research summary
Summary of Research
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.Additionally:
- 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.
Summary of Results
The Aveir™ Dual-Chamber (DR) i2i Study was a prospective, multi-center, international, single-aim, pivotal investigational study designed to evaluate the safety and effectiveness of the Aveir DR Leadless Pacemaker (LP) system in a subject population indicated for a DDD(R) pacemaker to support regulato1y approval for both DDD(R) and AAI(R) pacing indications.
The Aveir DR LP system supports the implantation and use of an Aveir LP within the targeted chamber(s) of the heart for monitoring a patient's heart rate and providing rate-responsive bradycardia pacing therapy to regulate the heart rate. The Aveir LP (model LSP201A - right atrial and LSP202V right ventricular) is designed to provide bradycardia pacing as a pulse generator with built-in battery and electrodes for implantation in the right ventricle and/or right atrium. Abbott submitted a PMA clinical study report with 3-month data for the Aveir DR i2i Study to FDA in 2022, which reports on the primary and secondary safety and effectiveness data per the Global CIP. The Aveir DR system received FDA approval on June 29, 2023, Health Canada approval on August 14, 2023, and CE Mark approval from TUV on June 3, 2024.
Subjects were considered enrolled in the Aveir DR i2i Study upon providing written informed consent. Subject enrollment in the Aveir DR i2i IDE study began on February 2, 2022 in Czech Republic, February 24, 2022 in the US, April 7, 2022 in Canada, October 14, 2022 in Hong Kong, November 25, 2022 in Japan, and February 9, 2023 in Taiwan. The study enrolled 464 de novo subjects at 77 sites worldwide and 36 upgrade subjects at 16 sites worldwide as of the data cut-off date. By the cutoff date of June 14, 2024, de novo subjects with an attempted implant had a mean follow-up duration of 13.3 ± 5.5 subject-months (median duration 12.1 subject-months) with a cumulative total of 6,007 subject-months, upgrade subjects with an attempted implant had a mean follow-up duration of 11.8 ± 5.6 subject-months (median duration 11.5 subject-months) with a cumulative total of 425 subjectmonths.
There were three primary endpoints (one safety and two effectiveness) in this investigation. The primary safety endpoint evaluated the Aveir DR LP system complication-free-rate in de novo subjects based on CEC adjudication of adverse events at 12 months post-implant per the European CIP (ABTCIP-10428) and the Czech Republic CIP (ABT-CIP-10439) and 3 months post-implant per the Global CIP (ABT-CIP-10416). Among the 300 evaluable subjects, 88.6% of subjects were free from complications within 12 months post-implant. The one-sided 97.5% lower confidence bound for the complication-free rate was 84.5% and exceeded the performance goal of 76.5% (p<0.0001). Hence, the primary safety endpoint was met.
The primary effectiveness endpoint# 1 evaluated the composite success rate of acceptable atrial pacing thresholds and P-wave amplitudes in de novo subjects. Among the 292 subjects in the evaluable population, the 12-month composite success Rate was 92.8%. The one-sided 97.5% lower confidence bound for the success Rate was 89.7% and exceeded the performance goal of 80.0% (p<0.0001). Hence, the prima1y effectiveness endpoint # 1 was met.
The primary effectiveness endpoint #2 evaluated the 3-month AV synchrony success rate at rest while seated in de novo subjects. Among the 277 subjects in the evaluable population, the success RateAv was 98.2%. The one-sided 97.5% lower confidence bound for the success RateAv was 96.6% and exceeded the perfo1mance goal of 83% (p<0.0001). Hence, the prima1y effectiveness endpoint #2 was met.
There were 16 deaths in the de novo coho1t (3.4%, 16/464) as of the data cut-off date of which 3 were adjudicated as cardiovascular related and 2 out of 3 deaths were adjudicated as device or procedure related. The rate of SADEs in the de novo cohort of the Aveir DR i2i IDE study as of the data cut-off date is 15.0%. The rate of de novo cohort ADEs in the Aveir DR i2i IDE study as of the data cut-off date is 31.9%. Although there have been no CEC adjudicated UADEs/USADEs, Abbott reported 2 UADEs/USADEs to FDA: one (1) for a higher than anticipated rate of post-procedural device dislodgements and one (1) for an event of inability to release and re-dock LP to the delivery catheter.
Device electrical measurements and i2i measurements showed appropriate stability through the 24- month follow-up visit or the last visit as of the data cut-off date. In-clinic AV synchrony measurements showed excellent results with greater than 96% mean AV synchrony across all postures or activities at the 3-month visit. Results on the upgrade cohort are summarized in Appendix H.
The totality of data through the data cut-off date demonstrates that the Aveir DR Leadless Pacemaker System met the pre-specified primary safety and effectiveness endpoints and provides valid scientific evidence to conclude that the probable benefit to health from the use of the Aveir DR Leadless Pacemaker System outweighs any probable risk or injury.REC name
HSC REC B
REC reference
21/NI/0196
Date of REC Opinion
12 Jan 2022
REC opinion
Further Information Favourable Opinion