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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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Currently loop recorders diagnose arrhythmias and send automatic alerts to physicians based on R to R relationships only. We believe arrhythmia diagnostics could be improved if accurate detection of P and T waves as well as QRS complexes were possible.
There is no technique available for long term outpatient monitoring of QT intervals for patient at risk of torsade de pointes when receiving QT prolonging drugs. We believe that if an accurate T wave detection algorithm were developed loop recorders could be used to monitor the QT interval, and perhaps even provide alerts for patients at risk.
The objective of this study is to see if an algorithm can be developed to accurately define P and T waves using data from an implantable loop recorder.
Pilot Study of 20 prospective cardiology patients with loop recorders currently implanted for standard clinical indications.
Eligible Subjects will be brought into the office of John Wilson, MD or Marshall Winner, MD. After informed consent is obtained from Hatton Research Staff the following will be performed:
Independent Variables: These variables include age and race Dependent Variables: These variables include the data from the loop recorder, 12 lead EKG, Holter monitor and 30 second rhythm strip.
Intervention or experimental aspect of the study Subjects will have a 12 lead EKG performed with 30 second rhythm strip Subjects will complete a period of 24 hours in which they will wear a Holter monitor applied by Hatton Research Staff.
Statistical Analysis
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Loop Recorder | Device | Observation of Loop Recorder implanted for clinical reasons |
| Measure | Description | Time Frame |
|---|---|---|
| If an accurate algorithm to detect P and T waves along with QRS recognition were developed implantable loop recorders arrhythmia diagnostic capabilities could be improved and expanded. This study will collect data for the development of such algorithms. | Data analysis will be completed 1-2 months after enrollment complete |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects who currently have a loop recorder implanted
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lori Reid, MSN | Contact | (513)862-5124 | lori_reid@trihealth.com |
| Name | Affiliation | Role |
|---|---|---|
| John Wilson, MD | TriHealth Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TriHealth | Recruiting | Cincinnati | Ohio | 45242 | United States |
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| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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