Assessment of Thrombotic Status in Patients With Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title: Assessment of Thrombotic Status in Patients With Atrial Fibrillation

Status Not yet recruiting

Clinical Trial Summary

Investigators will assess the impact of treatments for atrial fibrillation on participant's thrombotic status

Clinical Trial Description

AF affects 1 in 4 people in their lifetime. Although generally thought of as a safe heart rhythm disturbance, the risk associated with AF is through the formation of clot (thrombus) within the heart which be ejected from the heart when it contracts causing a heart attack or perhaps more devastatingly a stroke.

The mainstay of treatment for AF involves thinning the blood with drugs such as warfarin or newer drugs termed novel oral anticoagulants. In addition to this there are 3 main ways of treating the underlying rhythm disturbance:

1. Accept the irregular heart rhythm and simply control the heart rate with heart rate limiting drugs such as beta blockers or digoxin in addition to the blood thinning medicines.

2. Restore the normal heart rhythm with with an electrical shock termed a direct current cardioversion (DCCV). This is usually a temporary measure, indeed 70% of whom will have reverted to AF by 12 months.

3. Attempt to permanently restore sinus rhythm through an atrial fibrillation ablation procedure.

The investigators study, through use of a relatively novel bedside test will examine the effects of each of these management strategies on the thrombotic status of the participant's blood.

Investigators will take blood from in total 500 participants divided between each of the above management strategies which has been decided by their parent teams (i.e. study does not affect their treatment).

Investigators will draw blood from the participants on up to 5 separate occasions over a 12 month period. In the group undergoing a DCCV, blood will be drawn shortly before and after the intervention and at 3 and 12 months post intervention. In the group undergoing an AF ablation blood will be drawn on 5 occasions - the day before the procedure, 1-2 days post, 3-4 days post, 3-4 months post and 12 months post. In the group treated with standard medical therapy, blood will be drawn at the time of enrolment in the study and at 3 and 12 months post enrolment.

It is the investigators hypothesis that permanent restoration of sinus rhythm through an atrial fibrillation ablation procedure will positively affect an individual participant's thrombotic status. There has been recent publication of registry data from the United States suggesting the long term rate of stroke in the population following an AF ablation approaches that of the population who have never suffered AF.

The investigators believe that the cause of the improvement in stroke rates following ablation is an improvement in thrombotic status which we hope to be test for the first time in a powered, prospective study. ;

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atrial Fibrillation

• NCT number: NCT02583971
• Study type: Observational
• Source: East and North Hertfordshire NHS Trust
• Contact: Diana Gorog, MD PhD FRCP
• Phone: 01707247512
• Email: mary.odonnell@nhs.net
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2016
• Completion date: September 2018