Cardiac Implantable Electronic Device (CIED) Research Study

Bradycardia Clinical Trial

Official title:

Cardiac Implantable Electronic Device (CIED) Research Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05061862
• Other study ID #: CIED Research Study
• Status: Recruiting
• Start date: March 17, 2022
• Est. completion date: March 30, 2024

Study information

• Verified date: November 2023
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Contact: Jennifer Smith
• Phone: 6124259143
• Email: jennifer.s.smith[@]medtronic.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: March 30, 2024
• Est. primary completion date: March 30, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Subject is at least 18 years of age.

2. Subject or legally authorized representative 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. Subjects who cannot tolerate lying supine for long periods period of time per investigator discretion.

4. Subject is enrolled in another study that could confound the results of this study, without documented pre-approval from a Medtronic study manager.

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Bradycardia
• Tachycardia

Intervention

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

Locations

Country	Name	City	State
United States	University of Virginia Medical Center	Charlottesville	Virginia
United States	Inova Fairfax Hospital	Falls Church	Virginia
United States	The Cardiac & Vascular Institute	Gainesville	Florida
United States	Lancaster General Hospital	Lancaster	Pennsylvania
United States	Sentara Norfolk General Hospital	Norfolk	Virginia
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	Oregon Health & Science University Hospital	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Product Development	Characterize Cardiovascular Implantable Electronic Device (CIED) implant and patient characteristics to support development of future CIED products and procedures.	3 years