Longitudinal Coverage With Evidence Development Study on Micra AV Leadless Pacemakers (Micra AV CED)

NCT04235491 | Active Not Recruiting

• 1 other identifier: Micra AV CED Study
• Study Type: observational
• Target: 37,000
• Locations: 1 country
• Sites: 1

Brief Summary

The primary purpose of the study is to meet the CMS mandated Coverage with Evidence Development requirement in the National Coverage Determination for Leadless Pacemakers as they apply to Medtronic Micra devices. The study uses administrative claims data of the Medicare population implanted with Micra AV leadless pacemakers or dual-chamber transvenous pacemakers. Patients are enrolled through submission of claims or encounter data to CMS.

Conditions

Bradycardia

Outcome Measures

Primary Outcomes (2)

• Acute complication rate

  Micra AV leadless pacemaker system and/or procedure related complications at 30 days. Acute complications include embolism/thrombosis, event at the puncture site, cardiac effusion/perforation, device-related complication, or other complications following the implantation of a Micra AV leadless pacemaker system. Subjects' administrative claims data will be reviewed to determine the occurrence of an acute complication.

  30 days

• The 2-year survival of patients implanted with a Micra AV leadless pacemaker

  Estimate the 2-year survival rate of patients implanted with a Micra AV leadless pacemaker

  2 years

Secondary Outcomes (2)

• Chronic complication rate

  6 months

• Device-related re-intervention rates

  2 years

Study Arms (2)

Micra AV leadless pacemaker therapy

All Medicare patients implanted with a Micra AV leadless pacemaker system

Dual Chamber Transvenous pacemaker

All Medicare patients implanted with full system (e.g. lead and generator) dual-chamber transvenous pacemakers

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study cohort will include all Medicare patients with continuous claims data implanted with a Micra AV leadless pacemaker or a full-system dual-chamber transvenous pacemaker in any US location.

You may qualify if:

• Medicare beneficiaries implanted with a Micra AV leadless pacemaker (CPT 0387T or 33274 or ICD-10 PCS 02HK3NZ) on or after the study start date will be included in the study.
• \- Medicare beneficiaries implanted with a dual-chamber ventricular transvenous pacemaker \[CPT 33208 or 33213 or 33214 or ICD-10 PCS ((0JH606Z or 0JH636Z) + (02H60JZ or 02H63JZ or 02H70JZ or 02H73JZ) + (02HK0JZ or 02HK3JZ))\] on or after the study start date.

You may not qualify if:

• None

Sponsors & Collaborators

• Medtronic: lead

Study Sites (1)

Emory University

Atlanta, Georgia, 30308, United States

Location

Related Publications (1)

• El-Chami MF, Higuera L, Longacre C, Stromberg K, Crossley G, Piccini JP. Two-year outcomes of Micra AV leadless pacemakers in the Micra AV CED study. Europace. 2024 Nov 1;26(11):euae273. doi: 10.1093/europace/euae273.

  PMID: 39485833 DERIVED

MeSH Terms

Conditions

Bradycardia

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mikhael El Chami, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2020
• First Posted: January 22, 2020
• Study Start: February 6, 2020
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)