Cardiac Implantable Electronic Device (CIED) Research Study

Medtronic

Status: Enrolling

Conditions: Bradycardia; Tachycardia; Arrhythmias, Cardiac

Treatments: Device: cardiac implantable electronic devices (CIEDs)

Study type: Observational

Funder types: Industry

Identifiers

NCT05061862

CIED Research Study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject is at least 18 years of age.
2. Subject is willing and able to provide written informed consent.
3. Subject is willing and able to complete the study procedures and visits for the duration of data collection requirements

Exclusion criteria

1. Subject is unwilling or unable to comply with study procedures as defined in the protocol.
2. Subject with a medical condition that precludes the patient from participation in the opinion of the investigator.
3. Subject is enrolled in another study that could confound the results of this study, without documented pre-approval from a Medtronic study manager.

Trial design

1,000 participants in 1 patient group

CIED Indicated Subjects

Description:

Subjects indicated to receive a cardiac implantable electronic devices (CIEDs)

Treatment:

Device: cardiac implantable electronic devices (CIEDs)