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

Monitoring QT Intervals Using LINQ/LINQII in Patients Undergoing Antiarrhythmic Drug Loading

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.

Study Overview

• Status: Completed
• Conditions: Arrhythmias, Cardiac; Atrial Arrhythmia; QT Interval, Variation in
• Intervention / Treatment: Device: LINQ/LINQ II

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 22

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32207
      • Baptist Hospital
  • Ohio
    • Columbus, Ohio, United States, 43214-3467
      • OhioHealth Research and Innovation Institute (OHRI)
  • Oregon
    • Coos Bay, Oregon, United States, 97420
      • Bay Area Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The subject population for the LINQ QT Study is a patient implanted with LINQ/LINQII or scheduled for a LINQ/LINQII and who are scheduled to receive an antiarrhythmic drug loading, may undergo this study.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
QT Intervals During Antiarrhythmic Loading Hospitalization	The QT intervals during antiarrhythmic loading will be compared for all patients with available LINQ ECG from the baseline anti arrhythmic loading hospitalization to analyze QT changes that may be caused due to antiarrhythmic drugs.	Assessed in the 2-hr period after each of the first four doses, difference between the maximum and minimum QTc interval reported

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure
• Investigators: Principal Investigator: Antony Chu, MD, Brown University

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2023
• Primary Completion (Actual): June 10, 2024
• Study Completion (Actual): July 23, 2024

Study Registration Dates

• First Submitted: August 2, 2022
• First Submitted That Met QC Criteria: August 2, 2022
• First Posted (Actual): August 4, 2022

Study Record Updates

• Last Update Posted (Actual): May 13, 2025
• Last Update Submitted That Met QC Criteria: April 25, 2025
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: MDT22018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share individual patient data with other researchers who were not investigators in the clinical study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No