HARNESS
Research type
Research Study
Full title
A randomised controlled trial to compare manual compression and suture-mediated haemostasis after catheter ablation of atrial fibrillation HARNESS: Haemostasis AfteR venous accESS in atrial fibrillation catheter ablation
IRAS ID
345085
Contact name
Dhiraj Gupta
Contact email
Sponsor organisation
Liverpool Heart and Chest Hospital
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
Summary of Research
Atrial fibrillation (AF) is the most common heart rhythm disorder affecting adults in the United Kingdom. In patients with AF who continue to experience symptoms despite medications, catheter ablation is an established interventional treatment. Ablation is performed by inserting a number of plastic tubes in the veins in the groin, in order to access the heart.Despite continued advances in equipment and techniques, groin complications remain the most common complications after AF ablation. The severity of these can range from minor (e.g. bleeding resolvable with manual pressure) to major (bleeding requiring blood transfusion, prolonged hospitalisation, intervention, or rarely resulting in death).
Following ablation, the plastic tubes in the groin are removed before leaving the procedure room. Once removed, the doctor will stop the bleeding in the groin. There are two commons ways in which the doctor can stop the bleeding: 1) conventional treatment with manual compression – the doctor applies pressure with their hands to the groin area to stop the bleeding; 2) suture treatment (also known as a “stitch”) – the doctor inserts a suture to the groin area and secures this in place with a small plastic device (called a three-way tap). The suture and three-way tap are left in place for a few hours before being removed. Both of these methods are commonly in use. However, there is no high-quality evidence to support whether one way is better than the other.
After stopping the bleeding, patients are generally asked to lay flat for 4 hours to prevent any bleeding. It is not known whether this duration can safely be shortened.
The Haemostasis AfteR veNous accESS in AF catheter ablation (HARNESS) trial is a pragmatic, single-centre, open label, randomised controlled trial which will compare a suture with a three-way tap to manual compression, and examine the impact of bed rest duration on clinical outcomes.
Summary of Results
Atrial fibrillation is a common abnormal heart rhythm that can be treated using a procedure called catheter ablation. During this procedure, several tubes are inserted into a large vein at the top of the leg. At the end of the procedure, bleeding from the vein needs to be stopped safely.The HARNESS study included 336 patients undergoing atrial fibrillation ablation at Liverpool Heart and Chest Hospital. Patients were randomly allocated to one of three groups. In the first group, bleeding was stopped by applying pressure to the vein by hand, followed by four hours of bed rest. In the second group, a temporary stitch was placed around the vein and secured using a small plastic tap, followed by four hours of bed rest. The third group received the same stitch but had only two hours of bed rest.
Bleeding or bruising around the top of the leg occurred less frequently with the stitch and four hours of bed rest (14.5% of patients) than with manual pressure (32.7%). The stitch also stopped bleeding more quickly and allowed patients to leave the procedure room sooner. No major bleeding or blood vessel complications occurred.
Reducing bed rest from four hours to two hours allowed patients to get up and walk sooner, but was associated with more minor bleeding or bruising.
Overall, the study showed that this simple, low-cost stitch was more effective than manual pressure for reducing minor complications after atrial fibrillation ablation.
REC name
North West - Preston Research Ethics Committee
REC reference
24/NW/0199
Date of REC Opinion
9 Jul 2024
REC opinion
Favourable Opinion