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

Completed

Conditions: Atrial Arrhythmia
QT Interval, Variation in
Arrhythmias, Cardiac

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.

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.

Recruitment & 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

Primary Outcome Measures

Name	Time	Method
QT Intervals During Antiarrhythmic Loading Hospitalization	Assessed in the 2-hr period after each of the first four doses, difference between the maximum and minimum QTc interval reported	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.

Secondary Outcome Measures

Name	Time	Method

Locations (3): Baptist Hospital
🇺🇸
Jacksonville, Florida, United States
OhioHealth Research and Innovation Institute (OHRI)
🇺🇸
Columbus, Ohio, United States
Bay Area Hospital
🇺🇸
Coos Bay, Oregon, United States