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

Medtronic

Status: Enrolling

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

Treatments: Device: LINQ/LINQ II

Study type: Observational

Funder types: Industry

Identifiers

NCT05488470

MDT22018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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