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Completed

NCT Number: NCT06470555

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

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Bleeding Cardiovascular Diseases Femoral Vein Injury Heart Diseases Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Liverpool Heart and Chest Hospital Foundation Trust

Liverpool, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

Femoral haemostasis using a figure-of-eight suture technique

Shortened bed rest duration of 2-hours

Other

Bed rest duration of 2-hours after initial haemostasis

Manual compression

Other

Femoral haemostasis using manual compression

Conventional bed rest duration of 4-hours

Other

Bed rest duration of 4-hours after initial haemostasis

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.

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

    Defined as:

    • 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
    • Development of local subcutaneous infection at the femoral venous access site.

Secondary outcomes

  1. Time from femoral sheath removal to leaving the cath lab

    Time frame: 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.

  2. Time from sheath removal to successful mobilisation without femoral venous access site complication

    Time frame: 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.

  3. Time from sheath removal to hospital discharge

    Time frame: 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.

  4. Rate of delayed discharge due to the need for femoral venous access site care

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Liverpool Heart and Chest Hospital NHS Foundation Trust

Other

Registry information

Official study title

A Randomised Controlled Trial to Compare Manual Compression and Suture-mediated Haemostasis After Catheter Ablation of Atrial Fibrillation

Acronym: HARNESS

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 24, 2024
Registry last updated
Jul 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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