Objective
To evaluate the efficacy of a wearable smart textile garment (Skiin Underwear) and associated software (Myant Health Platform) to record and store electrocardiograms (ECG) for subsequent detection of recurrent atrial arrhythmias following catheter ablation for atrial fibrillation, and to assess its impact on patient compliance, satisfaction, and overall quality of life.
Background
Catheter ablation has proven to be an effective treatment for atrial fibrillation. Following ablation, patients will undergo monitoring for recurrence of atrial fibrillation. These monitoring techniques include shorter strategies like 24-Hour Holter monitoring which may not capture atrial fibrillation and thus underestimate recurrence. Longer monitoring strategies like implantable cardiac monitors provide more data but are invasive. The development of textile wearable monitors presents and opportunity for prolonged monitoring without invasive procedures.
Study Outcomes
Primary
- Incidence of any atrial tachyarrhythmia lasting ≥30 seconds during monitoring with Skiin garments within 6 months following catheter ablation for atrial fibrillation
Secondary
- Compliance of participants with wearable cardiac monitoring device over a 6-month period post-ablation
- Patient satisfaction with garments wearable cardiac monitoring device compared to intermittent 14-day cardiac monitoring
- Impact of wearable cardiac monitoring on the overall quality of life of participants post-ablation
- Time to the first recurrence of atrial tachyarrhythmia post-ablation during monitoring with Skiin garments.
Eligibility Criteria
The criteria below are a summary. Your study doctor will confirm whether this study is right for you.
Inclusion Criteria
- Adults aged 18 years or older.
- Diagnosed with paroxysmal or persistent atrial fibrillation.
- Scheduled to undergo catheter ablation for atrial fibrillation.
- Able to provide informed consent.
- Willing to wear the Skiin garments (chest band or bralette) for the duration of the study (approximately 1 month pre and 6 months post-ablation).
- Have a smartphone with an Operating System compatible with the Skiin Connected Life App (Android 9+ or iOS 13+)
Exclusion Criteria
- Adverse reaction to Skiin garments (e.g. skin allergy)
- Pacemaker and/or (ICD) implantable cardioverter defibrillator users.
- Pregnancy
About taking part
If you would like to learn more about taking part in this study, please contact our research team using the details on this page. We can walk you through what participation involves and answer any questions.