Haemostasis After Venous Access in Atrial Fibrillation Catheter Ablation: The HARNESS Trial
NCT Number: NCT06470555
Acronym: HARNESS
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Atrial Fibrillation|Femoral Vein Injury|Bleeding
Interventions: OTHER: A figure-of-eight suture secured with a three-way tap|OTHER: Shortened bed rest duration of 2-hours|OTHER: Manual compression|OTHER: Conventional bed rest duration of 4-hours
Sponsor: Liverpool Heart and Chest Hospital NHS Foundation Trust
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 336
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-15
Completion Date: 2025-08-15

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.

Primary Outcome Measures: The rate of any femoral venous access site complication from the time of initial haemostasis in the cath lab to end of follow-up., Defined as:

1. Bleeding (with or without haematoma formation) at the site of femoral venous access site after initial haemostasis:

   * Grade 1 - overt but minor bleeding requiring minimal bedside action(s) such as manual compression
   * Grade 2 - continuous or significant overt bleeding requiring timely investigation and/or action, such as ultrasound, non-invasive radiological assessment, fluid resuscitation, or blood transfusion
   * Grade 3 - continuous or significant overt bleeding requiring urgent or emergency interventional procedure (interventional radiology or surgical intervention), or resulting in critical illness
   * Grade 4 - continuous or significant overt bleeding resulting in death

   Trial definition of haematoma:
   * Grade 1 - Raised haematoma \< 6 cm in longest dimension
   * Grade 2 - Raised haematoma ≥ 6 cm in longest dimension
2. Development of local subcutaneous infection at the femoral venous access site., Patients will be followed up to hospital discharge or to 24 hours after randomisation (whichever is the sooner).
Secondary Outcome Measures: Time from femoral sheath removal to leaving the cath lab, Time (in minutes) from removal of femoral sheath(s) to exiting the cardiac catheter laboratory., Patients will be followed up to hospital discharge or to 24 hours after randomisation (whichever is the sooner).|Time from sheath removal to successful mobilisation without femoral venous access site complication, Time (in minutes) from removal of femoral sheath(s) to mobilisation without femoral access site complication., Patients will be followed up to hospital discharge or to 24 hours after randomisation (whichever is the sooner).|Time from sheath removal to hospital discharge, Time (in minutes) from removal of femoral sheath(s) to hospital discharge., Patients will be followed up to hospital discharge or to 24 hours after randomisation (whichever is the sooner).|Rate of delayed discharge due to the need for femoral venous access site care, Incidence of delayed discharge due to the need for femoral venous access site care., Patients will be followed up to hospital discharge or to 24 hours after randomisation (whichever is the sooner).