Cryoballoon PVI as First Line Treatment for Typical Atrial Flutter
Research type
Research Study
Full title
Cryoballoon Pulmonary Vein Isolation as First line treatment for Typical Atrial Flutter (CRAFT)
IRAS ID
236316
Contact name
Dhiraj Gupta
Contact email
Sponsor organisation
Liverpool Heart and Chest Hospital
Duration of Study in the UK
2 years, 6 months, 27 days
Research summary
Atrial Flutter (AFL) is an abnormal heart rhythm which puts patients at increased risk of problems such as a heart attack and stroke. One usual treatment employed involves the use of heat energy to make tiny burns (ablation) directed at tissues understood to be the pathway for the abnormal rhythm in the heart. This procedure is called radiofrequency ablation (RFA). Unfortunately, in some patients treated this way, their AFL returns due to undesirable healing of the ablated tissue. Also, up to half of patients treated this way develop another abnormal rhythm known as atrial fibrillation even if they did not previously suffer from atrial fibrillation.
The other treatment option we want to study involves freezing tissues (cryoballoon ablation), aiming to achieve electrical disconnection between the back of the heart and the veins, called Pulmonary Veins (PVs), which connect it to the lungs. Such a treatment is called Pulmonary Vein Isolation (PVI). The PVs are a common source for both atrial fibrillation and flutter, and cryoballoon PVI has already become an established treatment for atrial fibrillation, as it has been found to be much quicker, simpler, and able to lead to permanent disconnection and therefore more likelihood of freedom from the abnormal heart rhythm. Using RFA to attempt to achieve PVI is often difficult and tends not to lead to a permanent treatment of the abnormal heart rhythm as reconnections occur within the ablated tissue.
In this study, we asses the hypothesis that the use of cryoballoon PVI (‘novel’ treatment) to achieve the electrical disconnection between the pulmonary veins and the heart will lead to higher rates of freedom from abnormal heart rhythms and more improved quality of life than treatment using heat energy (radiofrequency ablation) directed at tissues thought to be the pathway for the abnormal rhythm (‘conventional treatment’).REC name
North West - Greater Manchester West Research Ethics Committee
REC reference
18/NW/0074
Date of REC Opinion
12 Feb 2018
REC opinion
Favourable Opinion