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

NCT06470555 | Completed DMC

• 1 other identifier: IRAS 345085
• Study Type: interventional
• Target: 336
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Femoral Vein Injury; Bleeding

Keywords

Atrial fibrillation; Catheter ablation; Femoral haemostasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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 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 from sheath removal 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

  Patients will be followed up to hospital discharge or to 24 hours after randomisation (whichever is the sooner).

Study Arms (3)

Manual compression with 4-hours of bed rest

ACTIVE COMPARATOR

Femoral haemostasis using manual compression. Bed rest duration of 4 hours following initial haemostasis.

Other: Manual compression; Other: Conventional bed rest duration of 4-hours

A figure-of-eight suture secured with a three-way tap with 4-hours of bed rest;

EXPERIMENTAL

Femoral haemostasis using a figure-of-eight suture secured with a three-way tap. Bed rest duration of 4 hours following initial haemostasis.

Other: A figure-of-eight suture secured with a three-way tap; Other: Conventional bed rest duration of 4-hours

A figure-of-eight suture secured with a three-way tap with 2-hours of bed rest;

EXPERIMENTAL

Femoral haemostasis using a figure-of-eight suture secured with a three-way tap. Bed rest duration of 2 hours following initial haemostasis.

Other: A figure-of-eight suture secured with a three-way tap; Other: Shortened bed rest duration of 2-hours

Interventions

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

Femoral haemostasis using a figure-of-eight suture technique

A figure-of-eight suture secured with a three-way tap with 2-hours of bed rest;; A figure-of-eight suture secured with a three-way tap with 4-hours of bed rest;

Shortened bed rest duration of 2-hours OTHER

Bed rest duration of 2-hours after initial haemostasis

A figure-of-eight suture secured with a three-way tap with 2-hours of bed rest;

Manual compression OTHER

Femoral haemostasis using manual compression

Manual compression with 4-hours of bed rest

Conventional bed rest duration of 4-hours OTHER

Bed rest duration of 4-hours after initial haemostasis

A figure-of-eight suture secured with a three-way tap with 4-hours of bed rest;; Manual compression with 4-hours of bed rest

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Patients scheduled for AF catheter ablation with proposed femoral venous access, regardless of their gender identity, ethnicity and religious belief.
• ≤ 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
• Four or fewer femoral venous sheaths in situ (size range: 6 Fr to 17 Fr) with planned removal in lab
• Sizeable (\>5cm) puncture-related haematoma requiring manual compression prior to femoral venous sheath removal
• Presence of femoral arterial sheath

Sponsors & Collaborators

• Liverpool Heart and Chest Hospital NHS Foundation Trust: lead

Study Sites (1)

Liverpool Heart and Chest Hospital Foundation Trust

Liverpool, United Kingdom

Location

MeSH Terms

Conditions

Atrial Fibrillation; Hemorrhage

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dhiraj Gupta, MD

  Liverpool Heart and Chest Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: June 24, 2024
• Study Start: August 27, 2024
• Primary Completion: July 18, 2025
• Study Completion: July 18, 2025
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)