Haemostasis After Venous Access in Atrial Fibrillation Catheter Ablation: The HARNESS Trial

Summary

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.

Conditions

• Atrial Fibrillation
• Femoral Vein Injury
• Bleeding

Interventions

OTHER

A figure-of-eight suture secured with a three-way tap

Femoral haemostasis using a figure-of-eight suture technique

OTHER

Shortened bed rest duration of 2-hours

Bed rest duration of 2-hours after initial haemostasis

OTHER

Manual compression

Femoral haemostasis using manual compression

OTHER

Conventional bed rest duration of 4-hours

Bed rest duration of 4-hours after initial haemostasis

Sponsors & Collaborators

• Liverpool Heart and Chest Hospital NHS Foundation Trust

  lead OTHER

Principal Investigators

• Dhiraj Gupta, MD · Liverpool Heart and Chest Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-08-27

Primary Completion

2025-07-18

Completion

2025-07-18

Countries

• United Kingdom

Study Locations