Discrimination of P and T Waves With Linq and Holter

NCT02957006 | Unknown

• 1 other identifier: 15-120
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Arrhythmias, Cardiac

Outcome Measures

Primary Outcomes (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.

  Data analysis will be completed 1-2 months after enrollment complete

Interventions

Loop Recorder DEVICE

Observation of Loop Recorder implanted for clinical reasons

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects who currently have a loop recorder implanted

You may qualify if:

• Subject currently has a Medtronic loop recorder implanted
• Subject has large enough P and T wave amplitudes present per discretion of MD.

You may not qualify if:

• Subjects with inadequate sized P and T waves

Sponsors & Collaborators

• TriHealth Inc.: lead
• Medtronic: collaborator

Study Sites (1)

TriHealth

Cincinnati, Ohio, 45242, United States

RECRUITING

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• John Wilson, MD

  TriHealth Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lori Reid, MSN

CONTACT

(513)862-5124; lori_reid@trihealth.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2016
• First Posted: November 7, 2016
• Study Start: October 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: March 23, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)