NCT06470555Befejeződött
Haemostasis After Venous Access in Atrial Fibrillation Catheter Ablation: The HARNESS Trial
A Randomised Controlled Trial to Compare Manual Compression and Suture-mediated Haemostasis After Catheter Ablation of Atrial Fibrillation
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. júl. 29.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Befejeződött
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 336 (tényleges)
- Első benyújtás
- 2024. jún. 17.
- Kezdés
- 2024. aug. 27.
- Elsődleges befejezés
- 2025. júl. 18.
- Fő szponzor
- Liverpool Heart and Chest Hospital NHS Foundation Trust
- Betegségek
- Pitvarfibrilláció
- NCT-szám
- NCT06470555
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Bevont résztvevők: 336
- 2024. aug. 27. és az elsődleges befejezés (2025. júl. 18.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- Any haematoma at planned puncture site prior to femoral sheath insertion
- Sizeable (>5cm) puncture-related haematoma requiring manual compression prior to femoral venous sheath removal
Más betegség
- Established diagnosis of any haematologic disorder or genetic defect predisposing to bleeding
- Electronic patient record technical failure leading to an inability to record participants' care
- A change in patient's clinical condition during procedure deemed by the operator sufficient to exclude from the trial
Életkor
- ≤ 18 years of age
Egyéb
- Planned bilateral femoral venous access
- Planned femoral arterial access
- 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.
- Presence of femoral arterial sheath
- Clinically suspected femoral arterial puncture
- Patient leaving lab with femoral venous sheath in situ
- Randomisation system not available
- Procedural complication requiring procedure termination
Kiket keres a vizsgálat
- Patients scheduled for AF catheter ablation with proposed femoral venous access, regardless of their gender identity, ethnicity and religious belief.
- Four or fewer femoral venous sheaths in situ (size range: 6 Fr to 17 Fr) with planned removal in lab
A regiszterben nem jelölt feltételek
- 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.
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Liverpool Heart and Chest Hospital Foundation Trust | Liverpool | Egyesült Királyság | Ismeretlen állapot |
Kapcsolódó publikációk
- 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 · PMID 41711619
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