LAUDABLE

• Research type

  Research Study

• Full title

  Left Atrial arrhythmia substrate identification by Ultra-high Density mapping after confirmed durABLE pulmonary vein isolation - a randomised controlled pilot study

• IRAS ID

  259663

• Contact name

  Emmanuel Williams

• Contact email

  emmanuel.williams@lhch.nhs.uk

• Sponsor organisation

  Liverpool Heart and Chest Hospital

• Duration of Study in the UK

  2 years, 4 months, 27 days

• Research summary

  Persistent atrial fibrillation (PeAF) is defined as continuous atrial fibrillation for 7 days or more. Approximately 10% of people are diagnosed with atrial fibrillation (AF) by age 80 years; and among people of European descent, 26% of men and 23% of women have a lifetime risk of developing AF after age 40.
  Catheter ablation by pulmonary vein isolation is the usual approach employed for PeAF. This involves making lesions within the pulmonary veins (the four large tubes at the back of the heart which connect the heart to the lungs) to achieve electrical isolation. Electrical isolation cuts off abnormal electrical triggers originating from the pulmonary veins. However, treatment outcomes are less than optimal with a lot of variability in success rates for different techniques. Hence, the optimal treatment strategy for patients with PeAF is not clear.

  In this pilot study, we aim to study two different treatment modalities of catheter ablation: cold balloon (cryoballoon, Group 1) and hot tip (radiofrequency ablation, Group 2) used in (electrically) isolating the pulmonary veins. There will be 1:1 randomisation to either of the two modalities. All participants will subsequently undergo a repeat procedure 2 months later to identify reconnections and to re-isolate the veins using the hot tip (radiofrequency ablation) guided by an ultra-high density mapping technology. During the repeat procedure, we will do further electrophysiological studies including assessing arrhythmia inducibility and measuring the extent of isolated areas. For participants in Group 2, we will also make some lesions in the back wall of the heart (posterior wall isolation) and recheck arrhythmia induciblity.

  All participants will be given a handheld ECG recording (Omron) device. Participants will be shown how to use the device to make daily 30-second recordings and when they have symptoms, to be reviewed. Follow up will be at 3, 6 and 12 months.

• REC name

  London - Harrow Research Ethics Committee

• REC reference

  19/LO/0640

• Date of REC Opinion

  7 Aug 2019

• REC opinion

  Further Information Favourable Opinion