Cardiac Implantable Electronic Device (CIED) Research Study

N/AActive Not RecruitingNCT05061862

Medtronic Cardiac Rhythm and Heart Failure1,000 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

1,000

Conditions

Arrhythmias, Cardiac Bradycardia Tachycardia

Interventions

cardiac implantable electronic devices (CIEDs)DEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (9)

The Cardiac & Vascular Institute

Gainesville, Florida, United States

Georgia Arrhythmia Consultants

Macon, Georgia, United States

Oregon Health & Science University Hospital

Portland, Oregon, United States

Outcomes

Primary Outcomes

Product Development

Characterize Cardiovascular Implantable Electronic Device (CIED) information, implant procedure details and/or patient characteristics to support development of future CIED products and procedures.

Time frame: 3 years

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.