Ignite Creation Date:
2024-07-17 @ 10:49 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06470555
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-06-17
Brief Title:
Haemostasis After Venous Access in Atrial Fibrillation Catheter Ablation The HARNESS Trial
Sponsor:
Liverpool Heart and Chest Hospital NHS Foundation Trust
Organization:
Liverpool Heart and Chest Hospital NHS Foundation Trust
Study Overview
Official Title:
A Randomised Controlled Trial to Compare Manual Compression and Suture-mediated Haemostasis After Catheter Ablation of Atrial Fibrillation
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HARNESS
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 eg 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
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 eg 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None