Cardiac Implantable Electronic Device (CIED) Research Study

Recruiting

• Conditions: Tachycardia; Arrhythmias, Cardiac; Bradycardia
• Interventions: Device: cardiac implantable electronic devices (CIEDs)

• Registration Number: NCT05061862
• Lead Sponsor: Medtronic Cardiac Rhythm and Heart Failure

Brief 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.

Study Timeline

• Study First Submitted: 2021-09-20
• Study First Submitted QC: 2021-09-20
• Study First Posted: 2021-09-30
• Study Start: 2022-03-06
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-08
• Last Update Posted: 2025-04-10
• Primary Completion: 2025-09-30
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CIED Indicated Subjects	cardiac implantable electronic devices (CIEDs)	Subjects indicated to receive a cardiac implantable electronic devices (CIEDs)

Primary Outcome Measures

Name	Time	Method
Product Development	3 years	Characterize Cardiovascular Implantable Electronic Device (CIED) information, implant procedure details and/or patient characteristics to support development of future CIED products and procedures.

Trial Locations

Locations (9)

UZ Leuven - Campus Gasthuisberg; 🇧🇪 Leuven, Belgium

The Cardiac & Vascular Institute; 🇺🇸 Gainesville, Florida, United States

Georgia Arrhythmia Consultants; 🇺🇸 Macon, Georgia, United States

Oregon Health & Science University Hospital; 🇺🇸 Portland, Oregon, United States

Lancaster General Hospital; 🇺🇸 Lancaster, Pennsylvania, United States

Allegheny General Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States

University of Virginia Medical Center; 🇺🇸 Charlottesville, Virginia, United States

Inova Fairfax Hospital; 🇺🇸 Falls Church, Virginia, United States

Sentara Norfolk General Hospital; 🇺🇸 Norfolk, Virginia, United States