NCT07270211

Brief Summary

The primary objective of this observational study is to evaluate whether magnetocardiography (MCG) findings more accurately predict clinical outcomes in patients with acquired Long QT syndrome compared to ECG. The secondary objective is to assess differences in QT interval length between MCG and ECG. The primary safety objective is to characterize the safety profile of the CardiAQ MCG device.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
19mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress6%
Apr 2026Dec 2027

First Submitted

Initial submission to the registry

November 25, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 8, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

March 5, 2026

Status Verified

March 1, 2026

Enrollment Period

1.7 years

First QC Date

November 25, 2025

Last Update Submit

March 3, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Number of successful dofetilide loading using Magnetocardiography

    Dofetilide loading is considered successful if the following conditions are met: 1. No excessive QTc prolongation QTc remains \<500 ms, and no \>15% increase from baseline. 2. No sustained VT or recurrent/symptomatic non-sustained VT (NSVT) suggestive of proarrhythmia. 3. No symptomatic bradycardia or hemodynamic instability 4. Stable renal function 5. No deterioration necessitating dose reduction or discontinuation. 6. Discharge on a stable dose

    Baseline

  • Number of successful dofetilide loading using Electrocardiogram

    Dofetilide loading is considered successful if the following conditions are met: 1. No excessive QTc prolongation QTc remains \<500 ms, and no \>15% increase from baseline. 2. No sustained VT or recurrent/symptomatic non-sustained VT (NSVT) suggestive of proarrhythmia. 3. No symptomatic bradycardia or hemodynamic instability 4. Stable renal function 5. No deterioration necessitating dose reduction or discontinuation. 6. Discharge on a stable dose

    Baseline

Secondary Outcomes (2)

  • Magnetocardiography - QT interval length

    Baseline

  • Electrocardiogram - QT interval length

    Baseline

Study Arms (1)

Subjects diagnosed with atrial fibrillation

Diagnostic Test: Magnetocardiography

Interventions

MagnetocardiographyDIAGNOSTIC_TEST

MCG is a non-invasive, radiation-free imaging technique that detects the magnetic field generated by the electrical activity of the heart.

Subjects diagnosed with atrial fibrillation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study candidates may be identified and recruited in one of the following ways: * In-patient service at the study institution. * From the Principal Investigator or Co-Investigator clinical practices * Referral from other hospitals * Cardiology Specialty Clinics

You may qualify if:

  • Age ≥ 18 years on the date of consent
  • Ability for participant to comply with study requirements
  • Written informed consent
  • Confirmed diagnosis of atrial fibrillation and receiving dofetilide for rhythm control in the inpatient setting.

You may not qualify if:

  • Pregnant or breastfeeding
  • Active thoracic metal implants (including pacemaker, insertable cardiac monitor, or internal defibrillators).
  • External electrical pads or devices (e.g. Pacer pads, ECG electrodes, heart rate patch), that must remain on patient's chest during MCG scan
  • Inability to lie down in a supine/inclined position and stay still on the examination bed
  • Clinical conditions that in the opinion of the Investigator would compromise the safety of the patient or ability to complete the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Magnetocardiography

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosisMagnetometryInvestigative Techniques

Study Officials

  • Mohamad Alkhouli, M.D., M.B.A.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patsy Caceres Figueroa

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 25, 2025

First Posted

December 8, 2025

Study Start

April 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

March 5, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations