Magnetocardiography in Long QT Syndrome: A Prospective Study of Its Clinical and Prognostic Utility
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Mayo Clinic
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Number of successful dofetilide loading using Magnetocardiography
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Arms & Interventions
Subjects diagnosed with atrial fibrillation
Intervention: Magnetocardiography (Diagnostic Test)
Outcomes
Primary Outcomes
Number of successful dofetilide loading using Magnetocardiography
Time Frame: Baseline
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
Number of successful dofetilide loading using Electrocardiogram
Time Frame: Baseline
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
Secondary Outcomes
- Magnetocardiography - QT interval length(Baseline)
- Electrocardiogram - QT interval length(Baseline)
Investigators
Mohamad Adnan Alkhouli
Principal Investigator
Mayo Clinic