Evaluation of CIED "Readers" for Disease Management

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-05

Study Completion Date

2019-07-16

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to evaluate the use of remote interrogation (readers) of CIEDs in evaluation of suspected TIA/stroke patients, HF or those experiencing syncope. This approach has the potential to advance the practice of CIED evaluation by staff without specialized training in cardiac electrophysiology (non-EP staff). We hypothesize that actionable events will be identified with use of CIED readers. These events may include identification of atrial fibrillation in TIA/stroke patients, percentage biventricular pacing in patients with HF or evaluation of arrhythmic events in syncope patients. We believe that non-EP staff will find CIED readers easy or very easy to use and that time from transmission to analysis for non-EP trained staff will be low.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Cardiac Implantable Electronic Device (CIED) Research Study

NCT05061862

Arrhythmias, Cardiac Bradycardia Tachycardia

ACTIVE_NOT_RECRUITING

Fluoroscopy Reduction or Elimination in CIED Implants

NCT04919733

Bradycardia Tachycardia, Ventricular Heart Failure

UNKNOWN NA

Decision Support for Adults Facing Implantable Cardioverter-Defibrillator Pulse Generator Replacement

NCT02668900

Death, Sudden, Cardiac Death, Sudden Cardiovascular Diseases

COMPLETED NA

Barriers to Use of Remote Monitoring in Patients With Implantable Cardioverter Defibrillators

NCT02361333

Cardiac Patients Implantable Cardioverter Defibrillator

COMPLETED NA

Remote Programming of Cardiac Implantable Electronic Device

NCT05366660

Defibrillators, Implantable Follow-Up Studies Pacemaker, Artificial +2 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Subjects with CIEDs undergoing evaluation for TIA/stroke, HF or syncope will be reviewed for inclusion/exclusion criteria. CIED interrogation, demographics and time of interrogation will be collected. Review of interrogation and medical record will be done to evaluate for actionable events including CIED programming, initiation or change in medications, admission/discharge or decision for further testing.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pacemaker Ddd ICD

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CIED subjects

CIED interrogation

Intervention Type DEVICE

CareLink Express interrogation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CIED interrogation

CareLink Express interrogation

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Remote monitoring

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* have a Medtronic CIED compatible with Medtronic CareLink Express
* being evaluated for heart failure, TIA/stroke or syncope
* able to read and speak English