Arrhythmias, Cardiac Clinical Trial
— LINQ QTOfficial title:
Monitoring QT Intervals Using LINQ in Patients Undergoing Antiarrhythmic Drug Loading
NCT number | NCT05488470 |
Other study ID # | MDT22018 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | January 31, 2023 |
Est. completion date | January 30, 2025 |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Medtronic Cardiac Rhythm and Heart Failure |
United States,
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 |
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