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

NCT ID: NCT06470555

Last Updated: 2025-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 336 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-27
• Study Completion Date: 2025-07-18

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Manual compression with 4-hours of bed rest

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

Group Type: ACTIVE_COMPARATOR

Manual compression

Intervention Type: OTHER

Femoral haemostasis using manual compression

Conventional bed rest duration of 4-hours

Intervention Type: 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;

Femoral haemostasis using a figure-of-eight suture secured with a three-way tap.

Bed rest duration of 4 hours following initial haemostasis.

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

Femoral haemostasis using a figure-of-eight suture technique

Conventional bed rest duration of 4-hours

Intervention Type: OTHER

Bed rest duration of 4-hours after initial haemostasis

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.

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

Femoral haemostasis using a figure-of-eight suture technique

Shortened bed rest duration of 2-hours

Intervention Type: OTHER

Bed rest duration of 2-hours after initial haemostasis

Interventions

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

Femoral haemostasis using a figure-of-eight suture technique

Intervention Type: OTHER

Shortened bed rest duration of 2-hours

Bed rest duration of 2-hours after initial haemostasis

Intervention Type: OTHER

Manual compression

Femoral haemostasis using manual compression

Intervention Type: OTHER

Conventional bed rest duration of 4-hours

Bed rest duration of 4-hours after initial haemostasis

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Patients scheduled for AF catheter ablation with proposed femoral venous access, regardless of their gender identity, ethnicity and religious belief.

Four or fewer femoral venous sheaths in situ (size range: 6 Fr to 17 Fr) with planned removal in lab

Exclusion Criteria

• ≤ 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Liverpool Heart and Chest Hospital NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dhiraj Gupta, MD

Role: STUDY_CHAIR

Liverpool Heart and Chest Hospital

Locations

Liverpool Heart and Chest Hospital Foundation Trust

Liverpool, , United Kingdom

Countries

United Kingdom

Other Identifiers

IRAS 345085

Identifier Type: -

Identifier Source: org_study_id