Catheter ablation in symptomatic atrial fibrillation

• Research type

  Research Study

• Full title

  Catheter ablation in symptomatic atrial fibrillation: a double blind randomised controlled trial

• IRAS ID

  274347

• Contact name

  Rick Veasey

• Contact email

  rick.veasey@nhs.net

• Sponsor organisation

  East Sussex Healthcare NHS Trust

• Duration of Study in the UK

  2 years, 0 months, 1 days

• Research summary

  Research Summary:
  Atrial fibrillation is the most common heart rhythm disorder and can cause unpleasant symptoms such as palpitations, shortness of breath and dizziness.

  Catheter ablation (cryoablation) is one treatment modality for atrial fibrillation and is indicated in patients who do not respond to medications. The procedure involves inserting two tubes in the groin and then passing a balloon up to the left side of the heart. The balloon is placed at the opening of the pulmonary veins, which are then frozen.

  Previous studies have shown ablation to improve symptoms and quality of life in atrial fibrillation patients however all previous studies have been single blinded meaning all patients are aware they are having an ablation procedure. To date we do not know if the improvement in symptoms after an ablation is due to a placebo effect or due to the actual effects of the ablation.

  The aim of this study is to compare the effectiveness of ablation versus a placebo procedure.

  Summary of Results:
  Catheter ablation / pulmonary vein isolation (PVI) is a procedure used to treat atrial fibrillation, a common heart rhythm disorder. This study aimed to determine if PVI with catheter ablation is more effective than a placebo (sham) procedure in reducing atrial fibrillation burden, symptoms and improving quality of life.
  A total of 126 patients were randomised. The main finding was that patients who received PVI had a significantly greater reduction in atrial fibrillation burden compared to those in the placebo (sham) group. Patients who underwent PVI also reported improvements in their quality of life and general health scores. These findings confirm that PVI provides real and meaningful benefits for people with symptomatic atrial fibrillation.

• REC name

  West Midlands - South Birmingham Research Ethics Committee

• REC reference

  19/WM/0361

• Date of REC Opinion

  10 Dec 2019

• REC opinion

  Further Information Favourable Opinion