CED: Aveir VR Coverage With Evidence Development Post-Approval Study

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05336877
• Collaborator: (none)
• Enrollment: 8,744
• Location: 1
• Anticipated Duration (Months): 66.4
• Patients Per Site Per Month: 131.8

Study Details

Study Description

Brief Summary

The purpose of this coverage with evidence development (CED) study is to evaluate complications and long-term health outcomes of the single-chamber Aveir Single-Chamber Leadless Pacemaker device (Aveir VR LP).

Condition or Disease	Intervention/Treatment	Phase
Cardiac Pacemaker; Arrythmia; Bradycardia	Device: Aveir VR Leadless Pacemaker System; Device: Single-Chamber Transvenous Pacemaker

Detailed Description

This is a non-randomized, multi-center study leveraging real-world evidence methods that merge multiple real-world datasets from Abbott and the Center for Medicare Services to compare Aveir VR LP safety and health outcomes to those in patients implanted with single-chamber transvenous pacemakers in a large patient population.

The study will enroll all Medicare patients implanted with the Aveir VR LP and, as the control group, patients implanted with a single-chamber ventricular transvenous pacemaker from any manufacturer.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 8744 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Aveir Single-Chamber Leadless Pacemaker Coverage With Evidence Development (ACED) Post-Approval Study
• Actual Study Start Date: Jun 21, 2022
• Anticipated Primary Completion Date: Jan 1, 2028
• Anticipated Study Completion Date: Jan 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
Device: Aveir VR Leadless Pacemaker System This study will utilize real-world data from patients implanted with the Aveir VR Leadless Pacemaker System. No device intervention is required in this study.	Device: Aveir VR Leadless Pacemaker System; This study will utilize real-world data from patients implanted with the Aveir VR Leadless Pacemaker System. No device intervention is required in this study.
Device: Single-Chamber Transvenous Pacemaker This study will utilize real-world data from patients implanted with a single-chamber transvenous pacemaker as a comparator to the Aveir VR LP system study arm. No device intervention is required in this study.	Device: Single-Chamber Transvenous Pacemaker; This study will utilize real-world data from patients implanted with a single-chamber transvenous pacemaker as a comparator to the Aveir VR LP system study arm. No device intervention is required in this study.

Outcome Measures

Primary Outcome Measures

1. Number of Subjects with Acute Device-Related Complications [30 days]

   Rate of acute complications in subjects implanted with an Aveir VR LP compared to subjects implanted with a single-chamber ventricular transvenous pacemaker. Acute complications are defined as a peri-procedural, device-related adverse event within 30 days post-implant.

2. Number of Subjects Alive after 2 Years [2 years]

   The 2-year survival rate of subjects implanted with an Aveir VR LP compared with subjects implanted with single-chamber ventricular transvenous pacemaker.

Secondary Outcome Measures

1. Number of Subjects with Chronic Device-Related Complications [6 months]

   Rate of chronic complications in subjects implanted with Aveir VR LP compared with subjects implanted with a single-chamber ventricular transvenous pacemaker, from 31 days through six months post implant procedure. A chronic complication is defined as a post-procedural, device-related adverse event that requires invasive intervention to resolve.

2. Number of Subjects with a Device-Related Re-Intervention [2 years]

   Rate of device-related re-intervention in subjects implanted with an Aveir VR LP compared to subjects implanted with a single-chamber ventricular transvenous pacemaker, through 2 years post implant procedure.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

The study cohort will include all Medicare patients with continuous claims data implanted with an Aveir VR leadless pacemaker or a full-system single-chamber ventricular transvenous pacemaker (from any manufacturer) in any US location

Inclusion Criteria:

Medicare beneficiaries implanted with an Aveir VR leadless pacemaker on or after the study start date (i.e., the date of Aveir VR market approval) will be included in the study.

OR

Medicare beneficiaries implanted with a full system (e.g. lead and generator) single-chamber ventricular transvenous pacemaker on or after the study start date

Exclusion Criteria:

None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Abbott	Sylmar	California	United States	91342

Sponsors and Collaborators

• Abbott Medical Devices

Investigators

• Study Director: Grant Kim, Abbott

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT05336877
• Other Study ID Numbers: ABT-CIP-10426
• First Posted: Apr 20, 2022
• Last Update Posted: Aug 11, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Bradycardia

Study Results

No Results Posted as of Aug 11, 2022