How does sinus node disease maintain atrial fibrillation? V1.1
Research type
Research Study
Full title
Endocardial mapping of atrial fibrillation in patients with sinus node disease
IRAS ID
249680
Contact name
Gwilym Morris
Contact email
Clinicaltrials.gov Identifier
not applicable, not applicable
Duration of Study in the UK
4 years, 8 months, 31 days
Research summary
The research study is intended to look at the specific role of sinus node disease (SND) in atrial fibrillation (AF), which to date has not been investigated. The mechanisms that maintain persistent AF are not well understood and we want to investigate if SND can cause AF by altering the electrical properties of the right atrium and act as a driver to maintain AF. It is known that SND frequently co-exists with AF, and the presence of SND is a predictor of poor success rates of catheter ablation treatment for AF. To better understand the interplay between these two disease states we plan to use electrical mapping of the heart to define the difference in atrial activity when SND is present or not, and to identify markers of electrical abnormality. With this information we may be better placed to develop targeted and personalised treatments or investigate new avenues of treatment to those who suffer from persistent AF.
We plan to recruit 40 participants within NHS hospitals. Participants will be recruited into 4 categories of which there should be 10 participants in each: (1) AF alone; (2) AF and SND; (3) No AF or SND (age-matched controls); (4) SND alone, requiring pacemaker implantation.
Participants in all categories will be due to undergo clinically indicated cardiac procedures; those in groups 1 and 2 will be due to undergo AF ablation, those in group 3 an SVT ablation and group 4 implantation of a permanent pacemaker. Following or during the clinical procedure we will carry out records of additional electrograms to map the atrial activity. For participants undergoing pacemaker implantation alone this will require carrying out an additional electrophysiology study.
The study will run for five years or until the required number of participants has been reached.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
19/NW/0057
Date of REC Opinion
25 Feb 2019
REC opinion
Favourable Opinion