Discrimination of P and T Waves With Linq and Holter

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.

Study Overview

• Status: Unknown
• Conditions: Arrhythmias, Cardiac
• Intervention / Treatment: Device: Loop Recorder

Detailed Description

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

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Recruiting
      • TriHealth
      • Contact: Lori Reid, MSN; Phone Number: (513)862-5124; Email: lori_reid@trihealth.com
      • Contact: Lori Reid, MSN; Phone Number: 513-862-2877; Email: lori_reid@trihealth.com
      • Principal Investigator: John Wilson, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects who currently have a loop recorder implanted

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: TriHealth Inc.
• Collaborators: Medtronic
• Investigators: Principal Investigator: John Wilson, MD, TriHealth Inc.

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: November 4, 2016
• First Submitted That Met QC Criteria: November 4, 2016
• First Posted (Estimate): November 6, 2016

Study Record Updates

• Last Update Posted (Actual): March 23, 2018
• Last Update Submitted That Met QC Criteria: March 22, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: 15-120

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No