This trial is no longer recruiting

Recruitment for this study has ended, so applications are closed. You can still read the trial details, or browse similar trials that are currently recruiting.

Not recruiting

CIED

Sponsor:

Medtronic Cardiac Rhythm and Heart Failure

Code:

NCT05061862

Conditions

Arrhythmias, Cardiac

Bradycardia

Tachycardia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

cardiac implantable electronic devices (CIEDs)

Study Details

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.

Conditions

Arrhythmias, Cardiac

Bradycardia

Tachycardia

Study ID

NCT05061862

Start date

Mar 6, 2022

Status verified date

Apr, 2025

Completion date

May 1, 2026

Anticipated

Primary completion date

Sep 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

CIED Indicated Subjects

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

Interventions

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.

Primary outcome measure

  • Product Development [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Amy A Lautenbach, MAOL

(763)360-9163amy.a.lautenbach@medtronic.com

Locations

Allegheny General Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15212

Principal Investigator:

Joshua Silverstein, MD

More Information

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Last update posted

Apr 10, 2025

Last verified

Apr, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-18. This information was provided to ClinicalTrials.gov by Medtronic Cardiac Rhythm and Heart Failure on 2025-04-10.