Discrimination of P and T Waves With Linq and Holter
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | October 2016 |
| End Date: | December 2018 |
| Contact: | Lori Reid, MSN |
| Email: | lori_reid@trihealth.com |
| Phone: | (513)862-5124 |
Discrimination of P and T-waves With Linq and Holter
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.
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:
- subjects will have an initial loop recorder download to USB flash drive
- 12 lead EKG
- Annotated QT intervals on a 30 second rhythm strip
- 24 hour Holter monitor placed by Hatton Research Staff in order to confirm the loop
recorder data.
- Subjects will be instructed on the Holter monitors care and use.
- Subjects will be scheduled to come back to the office after 24 hours to return the
Holter monitor and have a final loop recorder download completed.
- Data from the loop recorder, Holter monitor, 12 lead EKG, and 30 second rhythm strip
will be downloaded and de-identified per Hatton Research Staff.
- All de-identified data from the initial loop recorder download, 12 lead EKG, 30 second
rhythm strip, final loop recorder download, and Holter monitor will be sent to Medtronic
for algorithm development.
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
- Descriptive statistics (mean, standard deviation) will be calculated for all continuous
variables. Continuous variables will be compared using Student's - T test or ANOVA as
appropriate.
- Frequency and percentages will be calculated for all categorical variables.
- Categorical data will be compared using chi square or Fisher's Exact Test as appropriate
- Data variables will be assessed by Hatton Research Specialist
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:
- subjects will have an initial loop recorder download to USB flash drive
- 12 lead EKG
- Annotated QT intervals on a 30 second rhythm strip
- 24 hour Holter monitor placed by Hatton Research Staff in order to confirm the loop
recorder data.
- Subjects will be instructed on the Holter monitors care and use.
- Subjects will be scheduled to come back to the office after 24 hours to return the
Holter monitor and have a final loop recorder download completed.
- Data from the loop recorder, Holter monitor, 12 lead EKG, and 30 second rhythm strip
will be downloaded and de-identified per Hatton Research Staff.
- All de-identified data from the initial loop recorder download, 12 lead EKG, 30 second
rhythm strip, final loop recorder download, and Holter monitor will be sent to Medtronic
for algorithm development.
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
- Descriptive statistics (mean, standard deviation) will be calculated for all continuous
variables. Continuous variables will be compared using Student's - T test or ANOVA as
appropriate.
- Frequency and percentages will be calculated for all categorical variables.
- Categorical data will be compared using chi square or Fisher's Exact Test as appropriate
- Data variables will be assessed by Hatton Research Specialist
Inclusion Criteria:
- Subject currently has a Medtronic loop recorder implanted
- Subject has large enough P and T wave amplitudes present per discretion of MD.
Exclusion Criteria:
- Subjects with inadequate sized P and T waves
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