Haemostasis After Venous Access in Atrial Fibrillation Catheter Ablation: The HARNESS Trial (NCT06470555) | Clinical Trial Compass
CompletedNot Applicable
Haemostasis After Venous Access in Atrial Fibrillation Catheter Ablation: The HARNESS Trial
United Kingdom336 participantsStarted 2024-08-27
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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.
Timeframe: Patients will be followed up to hospital discharge or to 24 hours after randomisation (whichever is the sooner).
Trial details
NCT IDNCT06470555
SponsorLiverpool Heart and Chest Hospital NHS Foundation Trust