NCT05061862

Cardiac Implantable Electronic Device (CIED) Research Study

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

The study is designed to collect data on Cardiovascular Implantable Electronic Device (CIED) information, implant procedure details, and/or patient characteristics to support development of future CIED products and procedures.

Detailed description

This is a data collection, non-randomized, multi-center study. The study will consist of different cohorts with each cohort being independent from another cohort. Each cohort may have a distinct objective, cohort-specific subject population, procedures, and assessments. The study will follow subjects receiving routine care, who meet all of the inclusion criteria and none of the exclusion criteria.

Conditions

• Arrhythmias, Cardiac
• Bradycardia
• Tachycardia

Interventions

Type	Name	Description
DEVICE	cardiac implantable electronic devices (CIEDs)	Subjects will be implanted with various cardiac implantable electronic devices and followed according to their standard of care. Medical imaging will be collected at various stages of the implant procedure and/or non-invasive diagnostic collection at follow-up visits, as applicable.

Timeline

• Start date: 2022-03-06
• Primary completion: 2025-10-31
• Completion: 2026-05-01
• First posted: 2021-09-30
• Last updated: 2025-12-10

Locations

9 sites across 2 countries: United States, Belgium

Regulatory

• FDA-regulated device study