The FLUTTER Study

• Research type

  Research Study

• Full title

  Fluoroscopic, contact force and Local impedance with Ultra-high density mapping guided radiofrequency ablation comparison for cavoTricuspid isthmus dependenT atrial fluttER: the FLUTTER study

• IRAS ID

  281105

• Contact name

  Gwilym Morris

• Contact email

  Gwilym.morris@manchester.ac.uk

• Sponsor organisation

  University of Manchester

• Clinicaltrials.gov Identifier

  NCT04434599

• Clinicaltrials.gov Identifier

  N/A, N/A

• Duration of Study in the UK

  2 years, 1 months, 1 days

• Research summary

  Catheter ablation is a first-line treatment for patients with cavotricuspid isthmus (CTI) dependent atrial flutter (AFL; also known as typical AFL), a common arrhythmia. This is done using radiofrequency (RF) catheters and single-procedure success is approximately 95%. Ablation is often done using one of three methods:

  (1) fluoroscopically, using X-rays to guide the operator to visualise catheter position within the heart. This method involves the most radiation exposure to patient and operator.
  (2) using a 3-dimensional mapping system which allows the catheters to be magnetically located and visualised on a monitor without X-rays, and using "contact force" (CF) sensing catheters. This requires minimal X-ray use.
  (3) using an ultra-high density mapping system which uses magnetic tracking as above, but allows higher resolution visualisation of the cardiac electrical system with potential for improving procedure success; this has not yet been formally evaluated for AFL. Catheters using this method use "local impedance" (LI) instead of CF. This is a direct measure of heart tissue impedance with real-time changes during ablation. A minimum drop or plateau in the LI value during ablation allows confidence of lesion success, without the need to ablate for a pre-defined time-period. This could potentially reduce ablation time and subsequent complications, but has also not yet been formally compared to the above for this indication.

  This prospective randomised study aims to compare these three standard of care procedures to determine if differences in ablation metrics, efficacy and safety exist.

  NHS patients undergoing firts type typical AFL ablation will be recruited at a number of NHS centres, with randomisation into one of the above three methods, and no other research procedures. The study will last approximately 2 years.

• REC name

  North West - Greater Manchester East Research Ethics Committee

• REC reference

  20/NW/0411

• Date of REC Opinion

  9 Nov 2020

• REC opinion

  Further Information Favourable Opinion