Monitoring QT Intervals Using LINQ/LINQII in Patients Undergoing Antiarrhythmic Drug Loading
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 22
- Locations
- 3
- Primary Endpoint
- QT Intervals During Antiarrhythmic Loading Hospitalization
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
QT Intervals During Antiarrhythmic Loading Hospitalization
Time Frame: 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 Outcomes
No secondary outcomes reported