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

NCT05488470 | Completed Results

• 1 other identifier: MDT22018
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Atrial Arrhythmia; QT Interval, Variation in; Arrhythmias, Cardiac

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

LINQ/LINQ II DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (3)

Baptist Hospital

Jacksonville, Florida, 32207, United States

Location

OhioHealth Research and Innovation Institute (OHRI)

Columbus, Ohio, 43214-3467, United States

Location

Bay Area Hospital

Coos Bay, Oregon, 97420, United States

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Continuous telemetered ICM ECG data available during the index antiarrhythmic loading hospitalization period was collected and available in 8 out of 21 patients enrolled (avg. age 68±6.5 years, 63% males) in the QT study and were included in this analysis. 12-lead ECG data was not available for 13 enrolled subjects due to Holter compatibility and technical issues.

Results Point of Contact

• Title: Antony Chu, M.D., FACC, FAHA, FHRS, FACP, Director of Complex Ablation - Arrhythmia Services Section
• Organization: Division of Cardiology at the Rhode Island and Miriam Hospital, Warren Alpert School of Medicine, Brown University

antony_chu@brown.edu

401-444-8689

Study Officials

• Antony Chu, MD

  Brown University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2022
• First Posted: August 4, 2022
• Study Start: February 20, 2023
• Primary Completion: June 10, 2024
• Study Completion: July 23, 2024
• Last Updated: May 13, 2025
• Results First Posted: May 13, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)