Atrial ArrhythmiaLINQ QTNCT05488470

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

An observational study of Atrial Arrhythmia and QT Interval, Variation in, run by Medtronic Cardiac Rhythm and Heart Failure at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The LINQ QT Study is a prospective, non-randomized, multi-center, observational, post-market clinical study investigating QT interval changes due to antiarrhythmic drug loading. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Atrial Arrhythmia, QT Interval, Variation in, Arrhythmias, Cardiac
What is being tested?: LINQ/LINQ II
Type of treatment: Medical device
How many people: 22 participants
Where: 3 sitesUnited States
Study dates: 20 Feb 2023to 23 Jul 2024
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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
Patients who are scheduled to receive antiarrhythmic drug loading
Age 18-80
Patient is willing and able to comply with the protocol, including follow-up visits, and performing Holter recordings and patient activation transmissions

Who cannot join

Patients who have a contraindication to long-term antiarrhythmic therapy
Patients not suitable for long-term antiarrhythmic therapy
Patients with a previous, existing cardiac implantation (i.e., cardiac pacemaker or cardiac resynchronization requiring > 40% pacing, implantable cardioverter defibrillator (ICDs))
Patients with permanent and persistent AF
Co-enrollment in another study or planning to participate in a concurrent device study during the course of this clinical study that could confound the results

Trial locations and contacts

3 sites in 1 country.

United States3 sites

OhioHealth Research and Innovation Institute (OHRI)
Columbus, Ohio, 43214-3467
Bay Area Hospital
Coos Bay, Oregon, 97420
Baptist Hospital
Jacksonville, Florida, 32207

Other trials in United States

About this study

Official title: Monitoring QT Intervals Using LINQ/LINQII in Patients Undergoing Antiarrhythmic Drug Loading

The LINQ QT Study is a prospective, non-randomized, multi-center, observational, post-market clinical study investigating QT interval changes due to antiarrhythmic drug loading.

Read the detailed description

The purpose of this study is to determine if QT interval changes are detected during and after antiarrhythmic drug loading by the designed QT detection algorithm from LINQ ECG.

The QT intervals during the anti arrhythmic loading hospitalization period will be compared for all patients to analyze QT changes that may be caused due to antiarrhythmic drugs.

Conditions: Atrial Arrhythmia, QT Interval, Variation in, Arrhythmias, Cardiac
Being tested: LINQ/LINQ II
Medical subject headings: Arrhythmias, Cardiac

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Assessed in the 2-hr period after each of the first four doses, difference between the maximum and minimum QTc interval reported

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Feb 202323 Jul 2024

First posted4 Aug 2022
Study start20 Feb 2023
Primary completion10 Jun 2024
Study completion23 Jul 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Atrial ArrhythmiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Other
Time perspective: Prospective
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05488470
Sponsor's protocol ID: MDT22018
Acronym: LINQ QT
Status last verified: Sep 2024
First submitted: 2 Aug 2022
Last updated: 13 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: There is no plan to share individual patient data with other researchers who were not investigators in the clinical study.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Monitoring QT Intervals Using LINQ/LINQII in Patients Undergoing Antiarrhythmic Drug Loading
ClinicalTrials.gov ID: NCT05488470
Acronym / sponsor ID: LINQ QT / MDT22018
Conditions: Atrial Arrhythmia, QT Interval, Variation in, Arrhythmias, Cardiac
Study type: Observational
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
Study start: 20 Feb 2023 (actual)
Primary completion: 10 Jun 2024 (actual)
Study completion: 23 Jul 2024 (actual)
First posted: 4 Aug 2022 (actual)
Results: Posted 13 May 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The LINQ QT Study is a prospective, non-randomized, multi-center, observational, post-market clinical study investigating QT interval changes due to antiarrhythmic drug loading.

Detailed description

The purpose of this study is to determine if QT interval changes are detected during and after antiarrhythmic drug loading by the designed QT detection algorithm from LINQ ECG.

The QT intervals during the anti arrhythmic loading hospitalization period will be compared for all patients to analyze QT changes that may be caused due to antiarrhythmic drugs.

Study design

Observational model: Other
Time perspective: Prospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (4 listed)

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
Patients who are scheduled to receive antiarrhythmic drug loading
Age 18-80
Patient is willing and able to comply with the protocol, including follow-up visits, and performing Holter recordings and patient activation transmissions

Key exclusion criteria (5 listed)

Patients who have a contraindication to long-term antiarrhythmic therapy
Patients not suitable for long-term antiarrhythmic therapy
Patients with a previous, existing cardiac implantation (i.e., cardiac pacemaker or cardiac resynchronization requiring > 40% pacing, implantable cardioverter defibrillator (ICDs))
Patients with permanent and persistent AF
Co-enrollment in another study or planning to participate in a concurrent device study during the course of this clinical study that could confound the results

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LINQ/LINQ IIAlgorithm 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.	Device	–

Primary outcome

QT Intervals During Antiarrhythmic Loading Hospitalization
Time frame: Assessed in the 2-hr period after each of the first four doses, difference between the maximum and minimum QTc interval reported
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.

Results and safety

Results posted to the registry on 13 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Subjects	22	18

Primary outcome: QT Intervals During Antiarrhythmic Loading Hospitalization

Time frame: Assessed in the 2-hr period after each of the first four doses, difference between the maximum and minimum QTc interval reported. Mean (Standard Deviation). Unit: milliseconds

Measure	QTc Interval Trends Observed During the Anti Arrhythmic Loading Hospitalization n = 8
Value	21.8 (9.4)

Population analysed: 8 patients (avg. age 68±6.5 years, 63% males) with available LINQ ECG data during the anti arrhythmic loading hospitalization.

Adverse events

Time frame: 90 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Subjects	2 of 21 (9.5%)	0 of 21 (0%)	1 of 21

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. There is no plan to share individual patient data with other researchers who were not investigators in the clinical study.

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Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax
Chronic Lymphocytic Leukemia (CLL), Waldenstr(SqrRoot)(Delta)m s Macroglobulinemia
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Antony Chu, MD principal investigator

Brown University

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Arrhythmia and QT Interval, Variation in, run by Medtronic Cardiac Rhythm and Heart Failure at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

QT Intervals During Antiarrhythmic Loading Hospitalization (time frame: Assessed in the 2-hr period after each of the first four doses, difference between the maximum and minimum QTc interval reported). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05488470.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025; AzTrials last refreshed its copy on 31 Oct 2026.