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

Liverpool Heart and Chest Hospital NHS Foundation Trust336 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Interventions

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

Femoral haemostasis using a figure-of-eight suture technique

Shortened bed rest duration of 2-hoursOTHER

Bed rest duration of 2-hours after initial haemostasis

Manual compressionOTHER

Femoral haemostasis using manual compression

Conventional bed rest duration of 4-hoursOTHER

Bed rest duration of 4-hours after initial haemostasis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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. Exclusion Criteria for Pre-Lab Phase - Screening and Consent: * ≤ 18 years of age * Planned bilateral femoral venous access * Planned femoral arterial access * Any haematoma at planned puncture site prior to femoral sheath insertion * Established diagnosis of any haematologic disorder or genetic defect predisposing to bleeding * Inability to perform adequate consent: * Communication issues (e.g. mental capacity, forgotten glasses) * Inadequate time for the participant to read and consider trial * Unscheduled Urgent or Emergency procedures * Patients who are scheduled to be transferred to other hospitals ("treat and return") before haemostasis is achieved. * Electronic patient record technical failure leading to an inability to record participants' care Inclusion Criteria for In-Lab Phase - Before Randomisation Four or fewer femoral venous sheaths in situ (size range: 6 Fr to 17 Fr) with planned removal in lab Exclusion Criteria for In-lab Phase - Before Randomisation * Sizeable (\>5cm) puncture-related haematoma requiring manual compression prior to femoral venous sheath removal * Presence of femoral arterial sheath * Clinically suspected femoral arterial puncture * Patient leaving lab with femoral venous sheath in situ * Randomisation system not available * A change in patient's clinical condition during procedure deemed by the operator sufficient to exclude from the trial * Procedural complication requiring procedure termination

Outcomes

Primary Outcomes

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.