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Aveir VR Coverage With Evidence Development Post-Approval Study (CED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05336877
Recruitment Status : Not yet recruiting
First Posted : April 20, 2022
Last Update Posted : June 22, 2022
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

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
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.

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Study Type : Observational
Estimated 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
Estimated Study Start Date : July 1, 2022
Estimated Primary Completion Date : January 1, 2028
Estimated Study Completion Date : January 1, 2028

Group/Cohort 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.




Primary Outcome Measures :
  1. Number of Subjects with Acute Device-Related Complications [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05336877


Contacts
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Contact: Clay Cohorn 972 309 8087 clay.cohorn@abbott.com
Contact: Binh Ngo 8184932060 binh.ngo1@abbott.com

Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Study Director: Clay Cohorn Abbott
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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT05336877    
Other Study ID Numbers: ABT-CIP-10426
First Posted: April 20, 2022    Key Record Dates
Last Update Posted: June 22, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Bradycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes