Atrial FibrillationHARNESSNCT06470555
Haemostasis After Venous Access in Atrial Fibrillation Catheter Ablation: The HARNESS Trial
A study testing A figure-of-eight suture secured with a three-way tap, Shortened bed rest duration of 2-hours and Manual compression in people with Atrial Fibrillation and Femoral Vein Injury, run by Liverpool Heart and Chest Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Femoral Vein Injury, Bleeding
- What is being tested?
- A figure-of-eight suture secured with a three-way tap, Shortened bed rest duration of 2-hours and Manual compression
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 336 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Aug 2024to 18 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Four or fewer femoral venous sheaths in situ (size range: 6 Fr to 17 Fr) with planned removal in lab
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Liverpool Heart and Chest Hospital Foundation Trust
Liverpool
About this study
Official title: 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).
Read more
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
- Being tested
- A figure-of-eight suture secured with a three-way tap, Shortened bed rest duration of 2-hours, Manual compression, Conventional bed rest duration of 4-hours
- Keywords
- Atrial fibrillation, Catheter ablation, Femoral haemostasis
- Medical subject headings
- Atrial Fibrillation, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A figure-of-eight suture secured with a three-way tapOther
Femoral haemostasis using a figure-of-eight suture technique
Shortened bed rest duration of 2-hoursOther
Bed rest duration of 2-hours after initial haemostasis
Manual compressionOther
Femoral haemostasis using manual compression
Conventional bed rest duration of 4-hoursOther
Bed rest duration of 4-hours after initial haemostasis
| Study group | Role | What they receive |
|---|---|---|
| Manual compression with 4-hours of bed rest | Active comparator | Femoral haemostasis using manual compression. Bed rest duration of 4 hours following initial haemostasis. Receives: Other: Manual compression; Other: Conventional bed rest duration of 4-hours |
| A figure-of-eight suture secured with a three-way tap with 4-hours of bed rest; | Experimental | Femoral haemostasis using a figure-of-eight suture secured with a three-way tap.
Bed rest duration of 4 hours following initial haemostasis. Receives: Other: A figure-of-eight suture secured with a three-way tap; Other: Conventional bed rest duration of 4-hours |
| A figure-of-eight suture secured with a three-way tap with 2-hours of bed rest; | Experimental | Femoral haemostasis using a figure-of-eight suture secured with a three-way tap.
Bed rest duration of 2 hours following initial haemostasis. Receives: Other: A figure-of-eight suture secured with a three-way tap; Other: Shortened bed rest duration of 2-hours |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 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
- Development of local subcutaneous infection at the femoral venous access site.
Measured: Patients will be followed up to hospital discharge or to 24 hours after randomisation (whichever is the sooner).
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Patients will be followed up to hospital discharge or to 24 hours after randomisation (whichever is the sooner).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start27 Aug 2024
- Primary completion18 Jul 2025
- Study completion18 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 336 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liverpool Heart and Chest Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dhiraj Gupta, MD, Study chair, Liverpool Heart and Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06470555
- Sponsor's protocol ID
- IRAS 345085
- Acronym
- HARNESS
- Status last verified
- Jul 2025
- First submitted
- 17 Jun 2024
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mills MT, Calvert P, Tidbury L, Wilson K, Evans T, de Francesco L, Najm A, Tripathi R, Farinha JM, Xydis P, Thu K, Snowdon R, Borbas Z, Waktare J, Mahida SN, Denham N, Ashrafi R, Todd D, Modi S, Luther V, Gupta D. Figure-of-8 Suture With a 3-Way Tap Versus Manual Compression After Atrial Fibrillation Ablation: The HARNESS Randomized Controlled Trial. JACC Clin Electrophysiol. 2026 Jun;12(6):1316-1330. doi: 10.1016/j.jacep.2026.01.014. Epub 2026 Feb 19.
PubMed 41711619
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial to Compare Manual Compression and Suture-mediated Haemostasis After Catheter Ablation of Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT06470555
- Acronym / sponsor ID
- HARNESS / IRAS 345085
- Conditions
- Atrial Fibrillation, Femoral Vein Injury, Bleeding
- Keywords
- Atrial fibrillation, Catheter ablation, Femoral haemostasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 336 participants (actual)
- Lead sponsor
- Liverpool Heart and Chest Hospital NHS Foundation TrustUniversity, hospital or other
- Study start
- 27 Aug 2024 (actual)
- Primary completion
- 18 Jul 2025 (actual)
- Study completion
- 18 Jul 2025 (actual)
- First posted
- 24 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Manual compression with 4-hours of bed rest | Active comparator | Other: Manual compression, Other: Conventional bed rest duration of 4-hoursFemoral 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; | Experimental | Other: A figure-of-eight suture secured with a three-way tap, Other: Conventional bed rest duration of 4-hoursFemoral 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; | Experimental | Other: A figure-of-eight suture secured with a three-way tap, Other: Shortened bed rest duration of 2-hoursFemoral haemostasis using a figure-of-eight suture secured with a three-way tap. Bed rest duration of 2 hours following initial haemostasis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Four or fewer femoral venous sheaths in situ (size range: 6 Fr to 17 Fr) with planned removal in lab
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A figure-of-eight suture secured with a three-way tapFemoral haemostasis using a figure-of-eight suture technique | Other | 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 with 4-hours of bed rest; |
| Shortened bed rest duration of 2-hoursBed rest duration of 2-hours after initial haemostasis | Other | A figure-of-eight suture secured with a three-way tap with 2-hours of bed rest; |
| Manual compressionFemoral haemostasis using manual compression | Other | Manual compression with 4-hours of bed rest |
| Conventional bed rest duration of 4-hoursBed rest duration of 4-hours after initial haemostasis | Other | A figure-of-eight suture secured with a three-way tap with 4-hours of bed rest;, Manual compression with 4-hours of bed rest |
Primary outcome
The rate of any femoral venous access site complication from the time of initial haemostasis in the cath lab to end of follow-up.
Time frame: 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.
4 secondary outcomes
Time from femoral sheath removal to leaving the cath lab
Time frame: 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 frame: 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 frame: 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
Time frame: Patients will be followed up to hospital discharge or to 24 hours after randomisation (whichever is the sooner).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Derived from this study: PubMed 41711619Mills MT, Calvert P, Tidbury L, Wilson K, Evans T, de Francesco L, Najm A, Tripathi R, Farinha JM, Xydis P, Thu K, Snowdon R, Borbas Z, Waktare J, Mahida SN, Denham N, Ashrafi R, Todd D, Modi S, Luther V, Gupta D. Figure-of-8 Suture With a 3-Way Tap Versus Manual Compression After Atrial Fibrillation Ablation: The HARNESS Randomized Controlled Trial. JACC Clin Electrophysiol. 2026 Jun;12(6):1316-1330. doi: 10.1016/j.jacep.2026.01.014. Epub 2026 Feb 19.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dhiraj Gupta, MD study chair
Liverpool Heart and Chest Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A figure-of-eight suture secured with a three-way tap, Shortened bed rest duration of 2-hours and Manual compression in people with Atrial Fibrillation and Femoral Vein Injury, run by Liverpool Heart and Chest Hospital NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Patients will be followed up to hospital discharge or to 24 hours after randomisation (whichever is the sooner).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06470555, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2025.