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Discrimination of P and T Waves With Linq and Holter

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ClinicalTrials.gov Identifier: NCT02957006
Recruitment Status : Recruiting
First Posted : November 7, 2016
Last Update Posted : March 23, 2018
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
TriHealth Inc.

Brief Summary:

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.


Condition or disease Intervention/treatment
Arrhythmias, Cardiac 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

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Discrimination of P and T-waves With Linq and Holter
Study Start Date : October 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arrhythmia


Intervention Details:
  • Device: Loop Recorder
    Observation of Loop Recorder implanted for clinical reasons


Primary Outcome Measures :
  1. 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. [ Time Frame: Data analysis will be completed 1-2 months after enrollment complete ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects who currently have a loop recorder implanted
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02957006


Contacts
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Contact: Lori Reid, MSN (513)862-5124 lori_reid@trihealth.com

Locations
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United States, Ohio
TriHealth Recruiting
Cincinnati, Ohio, United States, 45242
Contact: Lori Reid, MSN    513-862-2877    lori_reid@trihealth.com   
Contact: Lori Reid, MSN    (513)862-5124    lori_reid@trihealth.com   
Principal Investigator: John Wilson, MD         
Sponsors and Collaborators
TriHealth Inc.
Medtronic
Investigators
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Principal Investigator: John Wilson, MD TriHealth Inc.

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Responsible Party: TriHealth Inc.
ClinicalTrials.gov Identifier: NCT02957006     History of Changes
Other Study ID Numbers: 15-120
First Posted: November 7, 2016    Key Record Dates
Last Update Posted: March 23, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes