Longitudinal Coverage With Evidence Development Study on Micra AV Leadless Pacemakers (Micra AV CED)
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|ClinicalTrials.gov Identifier: NCT04235491|
Recruitment Status : Active, not recruiting
First Posted : January 22, 2020
Last Update Posted : February 28, 2022
|Condition or disease|
The Micra AV CED study is a study of the Medicare beneficiary population implanted with Micra AV leadless pacemakers or dual-chamber transvenous pacemakers and will be executed by analyzing administrative claims data. The study consists of two primary objectives: estimate the (1) acute overall complication rate, and (2) the 2-year survival rate of patients implanted with a Micra AV leadless pacemaker. As part of the secondary objectives of the study, a comparative analysis of Micra AV leadless pacemakers to dual-chamber transvenous pacemakers will be conducted.
The analysis will be in CMS claims data and is subject to a central IRB. However, individual hospitals are not engaged in research and local IRB oversight is not necessary.
|Study Type :||Observational|
|Estimated Enrollment :||37000 participants|
|Official Title:||Longitudinal Coverage With Evidence Development Study on Micra AV Leadless Pacemakers|
|Actual Study Start Date :||February 6, 2020|
|Estimated Primary Completion Date :||June 2024|
|Estimated Study Completion Date :||June 2024|
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
- Acute complication rate [ Time Frame: 30 days ]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.
- The 2-year survival of patients implanted with a Micra AV leadless pacemaker [ Time Frame: 2 years ]Estimate the 2-year survival rate of patients implanted with a Micra AV leadless pacemaker
- Chronic complication rate [ Time Frame: 6 months ]Chronic complications are a subset of acute complications that may also occur within six months following the implantation of a Micra AV leadless pacemaker. Micra AV leadless pacemaker system and/or procedure related complications at six months. Subjects' administrative claims data will be reviewed to determine the occurrence of a chronic complication.
- Device-related re-intervention rates [ Time Frame: 2 years ]Device-related re-interventions are procedures associated with the insertion/replacement, revision, or removal or either a leadless or transvenous pacemaker system or components following the index implantation of a Micra AV leadless pacemaker. Device-related re-intervention rates will be reported at six month intervals for two years following the index implantation of a single-chamber ventricular pacemaker. Subjects' administrative claims data will be reviewed to determine the occurrence of a device-related re-intervention.
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): NCT04235491
|United States, Georgia|
|Atlanta, Georgia, United States, 30308|
|Principal Investigator:||Mikhael El Chami, MD||Emory University|