Atrial fibrillation treatment using new pulsed field ablation Circulatory System
Conditions
Interventions
This study will be conducted at the Royal Sussex County Hospital. A single-centre, 1:1 parallel-group randomised study will be conducted to explore the effect of PVI alone compared to PVI plus epicard
echocardiography and 24 ECG monitor performed as per standard of care before the day of the procedure.
The team consulted patient groups and members of the public in both the drafting and adaptation
Sponsors
University Hospitals Sussex NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults aged 18-80 years 2. Paroxysmal AF (episodes terminating spontaneously within 7 days) 3. Clinical indication for ablation 4. Left atrial size <5.5mm 5. Absence of significant structural heart disease or other contraindications to catheter ablation
Exclusion criteria
Exclusion criteria: 1. Female participants who are pregnant, lactating or planning pregnancy during the study 2. Current enrolment in another interventional trial 3. Considered clinically unsuitable 4. Patients lacking capacity 5. Declined Loop recorder implant/24-hour ECG monitor 6. Contraindication to anticoagulation. 7. Body Mass Index >40 8. Unable to use a smartphone with the ‘myMerlin’ application or mobile transmitter 9. Allergy to Steroids or multiple antibiotics
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean heart rate increases measured using a 24-hour ECG monitor at 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mean heart rate increases measured using a 24-hour ECG monitor at 12 months 2. Acute change in atrial effective refractory period measured using an ECG monitor during the procedure 3. Heart rate variability changes (SDNN, rMSSD, HF power) measured using a 24-hour ECG monitor at 3 and 12 months 4. Atrial fibrillation (AF) burden at 1 year following a 2-month blanking period, defined as the percentage of time in AF, measured using an implantable loop recorder (ILR) between 2 and 12 months of follow-up 5. AF burden during the 2-month blanking period, defined as the percentage of time in AF, measured using an ILR during the first 2 months 6. Atrial tachycardia (AT) burden at 1 year, following a 2-month blanking period, defined as the percentage of time in AT, measured using an ILR between 2 and 12 months of follow-up 7. Number of Ganglionated Plexi (GPs) identified at different pacing thresholds during high-frequency stimulation (HFS) [fixed pulse width of 10ms and variable current 1- 25mA] in the endocardium versus the epicardium during the procedure 8. Significant procedural-related complications (phrenic nerve palsy, atrial-oesophageal fistula, vascular injury requiring intervention, significant blood loss resulting in Hb drop >2g, cardiac tamponade, stroke or TIA, coronary vasospasm) were measured using patient medical records at discharge | — |
Countries
England, United Kingdom
Contacts
Public ContactIan Mann
Outcome results
None listed