Arrhythmias, Cardiac, Atrial Arrhythmia, QT Interval, Variation in
Conditions
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.
Interventions
DEVICELINQ/LINQ II
Algorithm developed and validated to continuously measure QT intervals for every beat using LINQ/LINQ II ECG. This study is aimed at determining if QT interval changes can be detected during antiarrhythmic drug loading by the designed QT detection algorithm from LINQ/LINQ II ECG.
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Subjects With Completed Baseline Anti Arrhythmic Loading Hospitalization Characteristics of Subjects with completed Baseline Anti Arrhythmic Loading Hospitalization | 21 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Physician Decision | 2 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Subjects With Completed Baseline Anti Arrhythmic Loading Hospitalization |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 17 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Age, Continuous | 71.5 years |
| Medical History Aortic Plaque | 1 participants |
| Medical History Atrial Fibrillation | 21 participants |
| Medical History Atrial Flutter | 5 participants |
| Medical History Cancer | 1 participants |
| Medical History Congestive Heart Failure | 7 participants |
| Medical History Coronary Artery Disease | 8 participants |
| Medical History Diabetes | 7 participants |
| Medical History Hypertension | 20 participants |
| Medical History Myocardial Infarction | 4 participants |
| Medical History Peripheral Artery Disease | 2 participants |
| Medical History Stroke | 2 participants |
| Medical History Thromboembolism | 1 participants |
| Medical History Transient Ischemic Attack | 1 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 20 Participants |
| Region of Enrollment United States | 21 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 21 |
| other Total, other adverse events | 0 / 21 |
| serious Total, serious adverse events | 2 / 21 |
Outcome results
Primary
QT Intervals During Antiarrhythmic Loading Hospitalization
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.
Time frame: Assessed in the 2-hr period after each of the first four doses, difference between the maximum and minimum QTc interval reported
Population: 8 patients (avg. age 68±6.5 years, 63% males) with available LINQ ECG data during the anti arrhythmic loading hospitalization.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| QTc Interval Trends Observed During the Anti Arrhythmic Loading Hospitalization | QT Intervals During Antiarrhythmic Loading Hospitalization | 21.8 milliseconds | Standard Deviation 9.4 |