Atrial Fibrillation, Bleeding, Femoral Vein Injury
Conditions
Keywords
Atrial fibrillation, Catheter ablation, Femoral haemostasis
Brief 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.
Interventions
OTHERA figure-of-eight suture secured with a three-way tap
Femoral haemostasis using a figure-of-eight suture technique
OTHERShortened bed rest duration of 2-hours
Bed rest duration of 2-hours after initial haemostasis
OTHERManual compression
Femoral haemostasis using manual compression
OTHERConventional bed rest duration of 4-hours
Bed rest duration of 4-hours after initial haemostasis
Sponsors
Liverpool Heart and Chest Hospital NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients will be randomised into one of three strategies for haemostasis (with a final allocation ratio of 1:1:1): * Conventional arm: Manual compression with 4-hours of bed rest; * Intervention arm 1: A figure-of-eight suture secured with a three-way tap (Fo8s-3wt) with 4-hours of bed rest; * Intervention arm 2: A Fo8s-3wt with 2-hours of bed rest.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The trial aims to recruit patients presenting to our institution for AF catheter ablation. Potential participants will be assessed against a two-tiered set of inclusion and
Exclusion criteria
. Inclusion Criteria for Pre-Lab Phase - Screening and Consent: Patients scheduled for AF catheter ablation with proposed femoral venous access, regardless of their gender identity, ethnicity and religious belief.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The rate of any femoral venous access site complication from the time of initial haemostasis in the cath lab to end of follow-up. | Patients will be followed up to hospital discharge or to 24 hours after randomisation (whichever is the sooner). | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time from femoral sheath removal to leaving the cath lab | Patients will be followed up to hospital discharge or to 24 hours after randomisation (whichever is the sooner). | Time (in minutes) from removal of femoral sheath(s) to exiting the cardiac catheter laboratory. |
| Time from sheath removal to successful mobilisation without femoral venous access site complication | Patients will be followed up to hospital discharge or to 24 hours after randomisation (whichever is the sooner). | Time (in minutes) from removal of femoral sheath(s) to mobilisation without femoral access site complication. |
| Time from sheath removal to hospital discharge | Patients will be followed up to hospital discharge or to 24 hours after randomisation (whichever is the sooner). | Time (in minutes) from removal of femoral sheath(s) to hospital discharge. |
| Rate 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). | Incidence of delayed discharge due to the need for femoral venous access site care. |
Countries
United Kingdom
Outcome results
None listed