Trials Sponsors Conditions Drugs Pricing

Conditions

Arrhythmias, Cardiac Atrial Arrhythmia QT Interval, Variation in

Outcome Measures

Primary Outcomes (1)

QT Intervals During Antiarrhythmic Loading Hospitalization
The QT intervals during antiarrhythmic loading will be compared for all patients with available LINQ ECG from the baseline anti arrhythmic loading hospitalization to analyze QT changes that may be caused due to antiarrhythmic drugs.
Assessed in the 2-hr period after each of the first four doses, difference between the maximum and minimum QTc interval reported

Interventions

LINQ/LINQ IIDevice

Algorithm developed and validated to continuously measure QT intervals for every beat using LINQ/LINQ II ECG. This study is aimed at determining if QT interval changes can be detected during antiarrhythmic drug loading by the designed QT detection algorithm from LINQ/LINQ II ECG.

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

The subject population for the LINQ QT Study is a patient implanted with LINQ/LINQII or scheduled for a LINQ/LINQII and who are scheduled to receive an antiarrhythmic drug loading, may undergo this study.

You may qualify if:

Patients implanted with LINQ/LINQII prior to the study enrollment (no more than 50% patients implanted with LINQII), but no greater than 2.5 years for LINQ or 3.5 years for LINQII, or patients who are indicated to receive a LINQ/LINQII implant at least 7 days prior to antiarrhythmic drug loading

Sponsors & Collaborators

Medtronic Cardiac Rhythm and Heart Failure
Industrylead

Study Sites (3)

Baptist Hospital

Jacksonville, Florida, 32207, United States

OhioHealth Research and Innovation Institute (OHRI)

Columbus, Ohio, 43214-3467, United States

Bay Area Hospital

Coos Bay, Oregon, 97420, United States

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Limitations and Caveats

Continuous telemetered ICM ECG data available during the index antiarrhythmic loading hospitalization period was collected and available in 8 out of 21 patients enrolled (avg. age 68±6.5 years, 63% males) in the QT study and were included in this analysis. 12-lead ECG data was not available for 13 enrolled subjects due to Holter compatibility and technical issues.

Results Point of Contact

Title: Antony Chu, M.D., FACC, FAHA, FHRS, FACP, Director of Complex Ablation - Arrhythmia Services Section
Organization: Division of Cardiology at the Rhode Island and Miriam Hospital, Warren Alpert School of Medicine, Brown University

Study Officials

Antony Chu, MD
Brown University
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

22 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: OTHER
Time Perspective: PROSPECTIVE
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

August 2, 2022

First Posted

August 4, 2022

Study Start

February 20, 2023

Actual (reported)

QT Changes as Detected From LINQ ECG During Antiarrhythmic Loading (LINQ QT)

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations