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

Arrhythmias, Cardiac Clinical Trial

— LINQ QT  

Official title:

Monitoring QT Intervals Using LINQ in Patients Undergoing Antiarrhythmic Drug Loading

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05488470
• Other study ID #: MDT22018
• Status: Recruiting
• Start date: January 31, 2023
• Est. completion date: January 30, 2025

Study information

• Verified date: October 2023
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Contact: Amy A Lautenbach, BS, MAOL
• Phone: 7633609163
• Email: amy.a.lautenbach[@]medtronic.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 before and after antiarrhythmic loading will be compared for all patients to analyze QT changes that may be caused due to antiarrhythmic drugs.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 30, 2025
• Est. primary completion date: January 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• 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 and after antiarrhythmic drug loading by the designed QT detection algorithm from LINQ/LINQ II ECG.

Locations

Country	Name	City	State
United States	OhioHealth Research and Innovation Institute (OHRI)	Columbus	Ohio
United States	Bay Area Hospital	Coos Bay	Oregon
United States	Baptist Hospital	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	QT intervals before and after antiarrhythmic loading	The QT intervals before and after antiarrhythmic loading will be compared for all patients to analyze QT changes that may be caused due to antiarrhythmic drugs.	90 days