Clinical trial NCT06470555: Haemostasis After Venous Access in Atrial Fibrillation Catheter Ablation: The HARNESS Trial
Official title: A Randomised Controlled Trial to Compare Manual Compression and Suture-mediated Haemostasis After Catheter Ablation of Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Femoral Vein Injury
Bleeding
Keywords: Atrial fibrillation
Catheter ablation
Femoral haemostasis
Lead sponsor: Liverpool Heart and Chest Hospital NHS Foundation Trust
Sponsor class: OTHER
First posted: 2024-06-24
Enrollment: 336
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: The rate of any femoral venous access site complication from the time of initial haemostasis in the cath lab to end of follow-up.
timeFrame: Patients will be followed up to hospital discharge or to 24 hours after randomisation (whichever is the sooner).
Secondary outcomes:
measure: Time from femoral sheath removal to leaving the cath lab
timeFrame: Patients will be followed up to hospital discharge or to 24 hours after randomisation (whichever is the sooner).
measure: Time from sheath removal to successful mobilisation without femoral venous access site complication
timeFrame: Patients will be followed up to hospital discharge or to 24 hours after randomisation (whichever is the sooner).
measure: Time from sheath removal to hospital discharge
timeFrame: Patients will be followed up to hospital discharge or to 24 hours after randomisation (whichever is the sooner).
measure: Rate of delayed discharge due to the need for femoral venous access site care
timeFrame: Patients will be followed up to hospital discharge or to 24 hours after randomisation (whichever is the sooner).
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: Liverpool Heart and Chest Hospital Foundation Trust
Study officials:
affiliation: Liverpool Heart and Chest Hospital
name: Dhiraj Gupta, MD
role: STUDY_CHAIR
References: