Clinical trial NCT05488470: QT Changes as Detected From LINQ ECG During Antiarrhythmic Loading (LINQ QT)
Official title: Monitoring QT Intervals Using LINQ/LINQII in Patients Undergoing Antiarrhythmic Drug Loading
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Arrhythmia
QT Interval, Variation in
Arrhythmias, Cardiac
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2022-08-04
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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 outcomes:
measure: QT Intervals During Antiarrhythmic Loading Hospitalization
timeFrame: Assessed in the 2-hr period after each of the first four doses, difference between the maximum and minimum QTc interval reported
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Baptist Hospital
state: Florida
city: Columbus
country: United States
facility: OhioHealth Research and Innovation Institute (OHRI)
state: Ohio
city: Coos Bay
country: United States
facility: Bay Area Hospital
state: Oregon
Study officials:
affiliation: Brown University
name: Antony Chu, MD
role: PRINCIPAL_INVESTIGATOR
References: