QT Changes as Detected From LINQ ECG During Antiarrhythmic Loading (LINQ QT)

NCT ID: NCT05488470

Last Updated: 2025-05-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

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

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-20

Study Completion Date

2024-07-23

Brief Summary

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

The LINQ QT Study is a prospective, non-randomized, multi-center, observational, post-market clinical study investigating QT interval changes due to antiarrhythmic drug loading.

Detailed Description

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

The purpose of this study is to determine if QT interval changes are detected during and after antiarrhythmic drug loading by the designed QT detection algorithm from LINQ ECG.

The QT intervals during the anti arrhythmic loading hospitalization period will be compared for all patients to analyze QT changes that may be caused due to antiarrhythmic drugs.

Conditions

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

Atrial Arrhythmia QT Interval, Variation in Arrhythmias, Cardiac

Study Design

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

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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

LINQ/LINQ II

Algorithm developed and validated to continuously measure QT intervals for every beat using LINQ/LINQ II ECG. This study is aimed at determining if QT interval changes can be detected during antiarrhythmic drug loading by the designed QT detection algorithm from LINQ/LINQ II ECG.

Intervention Type DEVICE

Eligibility Criteria

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

Inclusion Criteria

* Patients implanted with LINQ/LINQII prior to the study enrollment (no more than 50% patients implanted with LINQII), but no greater than 2.5 years for LINQ or 3.5 years for LINQII, or patients who are indicated to receive a LINQ/LINQII implant at least 7 days prior to antiarrhythmic drug loading
* Patients who are scheduled to receive antiarrhythmic drug loading
* Age 18-80
* Patient is willing and able to comply with the protocol, including follow-up visits, and performing Holter recordings and patient activation transmissions

Exclusion Criteria

* Patients who have a contraindication to long-term antiarrhythmic therapy
* Patients not suitable for long-term antiarrhythmic therapy
* Patients with a previous, existing cardiac implantation (i.e., cardiac pacemaker or cardiac resynchronization requiring \> 40% pacing, implantable cardioverter defibrillator (ICDs))
* Patients with permanent and persistent AF
* Co-enrollment in another study or planning to participate in a concurrent device study during the course of this clinical study that could confound the results
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Antony Chu, MD

Role: PRINCIPAL_INVESTIGATOR

Brown University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Baptist Hospital

Jacksonville, Florida, United States

Site Status

OhioHealth Research and Innovation Institute (OHRI)

Columbus, Ohio, United States

Site Status

Bay Area Hospital

Coos Bay, Oregon, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol: LINQ QT Study Protocol

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MDT22018

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

LQT and Smartphone/Smartwatch
NCT04728100 COMPLETED
Obstructive Sleep Apnoea and Cardiac Arrhythmias
NCT03866148 ACTIVE_NOT_RECRUITING NA
Ventricular Tachycardia Mechanisms
NCT05478213 RECRUITING NA