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

Not Applicable

Not yet recruiting

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

• Registration Number: NCT06470555
• Lead Sponsor: Liverpool Heart and Chest Hospital NHS Foundation Trust

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-17
• Study First Submitted QC: 2024-06-17
• Last Update Submitted: 2024-06-17
• Study First Posted: 2024-06-24
• Last Update Posted: 2024-06-24
• Study Start: 2024-08-15
• Primary Completion: 2025-08-15
• Study Completion: 2025-08-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 336

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Manual compression with 4-hours of bed rest	Manual compression	Femoral haemostasis using manual compression. Bed rest duration of 4 hours following initial haemostasis.
A figure-of-eight suture secured with a three-way tap with 4-hours of bed rest;	A figure-of-eight suture secured with a three-way tap	Femoral haemostasis using a figure-of-eight suture secured with a three-way tap. Bed rest duration of 4 hours following initial haemostasis.
Manual compression with 4-hours of bed rest	Conventional bed rest duration of 4-hours	Femoral haemostasis using manual compression. Bed rest duration of 4 hours following initial haemostasis.
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	Femoral haemostasis using a figure-of-eight suture secured with a three-way tap. Bed rest duration of 2 hours following initial haemostasis.
A figure-of-eight suture secured with a three-way tap with 4-hours of bed rest;	Conventional bed rest duration of 4-hours	Femoral haemostasis using a figure-of-eight suture secured with a three-way tap. Bed rest duration of 4 hours following initial haemostasis.
A figure-of-eight suture secured with a three-way tap with 2-hours of bed rest;	Shortened bed rest duration of 2-hours	Femoral haemostasis using a figure-of-eight suture secured with a three-way tap. Bed rest duration of 2 hours following initial haemostasis.

Primary Outcome Measures

Name	Time	Method
The rate of any femoral venous access site complication from the time of initial haemostasis in the cath lab to end of follow-up.	Patients will be followed up to hospital discharge or to 24 hours after randomisation (whichever is the sooner).	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.

Secondary Outcome Measures

Name	Time	Method
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 (in minutes) from removal of femoral sheath(s) to mobilisation without femoral access site complication.
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).	Time (in minutes) from removal of femoral sheath(s) to hospital discharge.
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).	Incidence of delayed discharge due to the need for femoral venous access site care.
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 (in minutes) from removal of femoral sheath(s) to exiting the cardiac catheter laboratory.

Trial Locations

Locations (1)

Liverpool Heart and Chest Hospital Foundation Trust; 🇬🇧 Liverpool, United Kingdom