Improving bleeding management after catheter ablation for atrial fibrillation
A Randomised Controlled Trial to Compare Manual Compression and Suture-mediated Haemostasis After Catheter Ablation of Atrial Fibrillation
This study tests two different ways to manage bleeding after catheter ablation for atrial fibrillation to see which one helps prevent serious groin complications better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 336 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Liverpool Heart and Chest Hospital NHS Foundation Trust Academic / other |
| Locations | 1 site (Liverpool) |
| Trial ID | NCT06470555 on ClinicalTrials.gov |
What this trial studies
This trial investigates methods to manage bleeding complications following catheter ablation for atrial fibrillation (AF). It compares two approaches: a figure-of-eight suture technique and conventional manual compression, alongside differing bed rest durations. The goal is to determine which method is more effective in preventing severe groin complications after the procedure. Participants will be patients scheduled for AF catheter ablation who meet specific inclusion criteria.
Who should consider this trial
Good fit: Ideal candidates are adults scheduled for catheter ablation of atrial fibrillation requiring femoral venous access.
Not a fit: Patients under 18 years old or those requiring bilateral femoral venous access or femoral arterial access may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer catheter ablation procedures with reduced bleeding complications for patients.
How similar studies have performed: Previous studies have shown varying success with different bleeding management techniques in similar procedures, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Liverpool
- Liverpool Heart and Chest Hospital Foundation Trust — Liverpool, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Mark Mills, MBChB MSc
- Email: mark.mills@lhch.nhs.uk
- Phone: 01516001616
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.