Recruiting

Linq & Holter

Sponsor:

TriHealth Inc.

Code:

NCT02957006

Conditions

Arrhythmias, Cardiac

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Loop Recorder

Study Details

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

Study ID

NCT02957006

Start date

Oct, 2016

Status verified date

Mar, 2018

Completion date

Dec, 2018

Anticipated

Primary completion date

Dec, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Interventions

Loop Recorder

Observation of Loop Recorder implanted for clinical reasons

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Locations

TriHealth

Recruiting

Cincinnati, Ohio, United States, 45242

Contacts

Principal Investigator:

John Wilson, MD

More Information

Sponsor

TriHealth Inc.

Last update posted

Mar 23, 2018

Last verified

Mar, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by TriHealth Inc. on 2018-03-23.