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

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

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 Overview

• Status: Completed
• Conditions: Atrial Fibrillation; Bleeding; Femoral Vein Injury
• Intervention / Treatment: Other: Manual compression; Other: Conventional bed rest duration of 4-hours; Other: A figure-of-eight suture secured with a three-way tap; Other: Shortened bed rest duration of 2-hours

• Study Type: Interventional
• Enrollment (Actual): 336
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Liverpool, United Kingdom
    • Liverpool Heart and Chest Hospital Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Manual compression with 4-hours of bed rest; Femoral haemostasis using manual compression. Bed rest duration of 4 hours following initial haemostasis.	Other: Manual compression; Femoral haemostasis using manual compression; Other: Conventional bed rest duration of 4-hours; Bed rest duration of 4-hours after initial haemostasis
Experimental: A figure-of-eight suture secured with a three-way tap with 4-hours of bed rest; Femoral haemostasis using a figure-of-eight suture secured with a three-way tap. Bed rest duration of 4 hours following initial haemostasis.	Other: Conventional bed rest duration of 4-hours; Bed rest duration of 4-hours after initial haemostasis; Other: A figure-of-eight suture secured with a three-way tap; Femoral haemostasis using a figure-of-eight suture technique
Experimental: A figure-of-eight suture secured with a three-way tap with 2-hours of bed rest; 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; Femoral haemostasis using a figure-of-eight suture technique; Other: Shortened bed rest duration of 2-hours; Bed rest duration of 2-hours after initial haemostasis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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: 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 compressionGrade 2 - continuous or significant overt bleeding requiring timely investigation and/or action, such as ultrasound, non-invasive radiological assessment, fluid resuscitation, or blood transfusionGrade 3 - continuous or significant overt bleeding requiring urgent or emergency interventional procedure (interventional radiology or surgical intervention), or resulting in critical illnessGrade 4 - continuous or significant overt bleeding resulting in deathTrial definition of haematoma:Grade 1 - Raised haematoma < 6 cm in longest dimensionGrade 2 - Raised haematoma ≥ 6 cm in longest dimension; 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

Outcome Measure	Measure Description	Time Frame
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).

Collaborators and Investigators

• Sponsor: Liverpool Heart and Chest Hospital NHS Foundation Trust
• Investigators: Study Chair: Dhiraj Gupta, MD, Liverpool Heart and Chest Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2024
• Primary Completion (Actual): July 18, 2025
• Study Completion (Actual): July 18, 2025

Study Registration Dates

• First Submitted: June 17, 2024
• First Submitted That Met QC Criteria: June 17, 2024
• First Posted (Actual): June 24, 2024

Study Record Updates

• Last Update Posted (Actual): July 29, 2025
• Last Update Submitted That Met QC Criteria: July 28, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Atrial fibrillation; Catheter ablation; Femoral haemostasis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Neurotransmitter Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Respiratory System Agents; Sympathomimetics; Vasoconstrictor Agents; Nasal Decongestants; Oxymetazoline
• Other Study ID Numbers: IRAS 345085

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No