Actively Recruiting
Ablation of Focal Activation During Persistent Atrial Fibrillation to Determine the Characteristics of Focal Drivers
Led by Imperial College London · Updated on 2024-05-07
110
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
I
Imperial College London
Lead Sponsor
I
Imperial College Healthcare NHS Trust
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the role of focal electrical activations in maintaining persistent atrial fibrillation AF. The study evaluates a new mapping technique called RETRO-Mapping, designed to detect these focal activations during AF. This approach aims to better understand the mechanisms behind persistent AF and whether targeting these focal drivers can improve treatment outcomes compared to standard care. All participants will undergo a standard pulmonary vein isolation PVI procedure using advanced 3D electroanatomic mapping systems. After PVI, patients are randomly assigned to either a control group, which receives RETRO-Mapping without additional ablation, or an intervention group, where RETRO-Mapping is used to identify and ablate focal activation sites. The intervention includes mapping 30-second segments of the atria, ablating identified focal activations, and assessing changes in AF cycle length to evaluate treatment effects. Participants will be monitored through detailed intra-procedural measurements, including AF cycle length in the coronary sinus and left atrial appendage. The main outcome is the change in AF cycle length during the procedure, and a secondary outcome is freedom from AF one year after treatment. The study involves follow-up assessments and safety monitoring, with a total participation duration extending to at least one year to track long-term effects and recurrence.
CONDITIONS
Brief Title
Ablation of Focal Activation in Atrial Fibrillation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Persistent atrial fibrillation with clinical indication for catheter ablation
- Clinically suitable candidate for catheter ablation
- Signed informed consent
You will not qualify if you...
- Previous atrial fibrillation or other catheter ablation procedure
- Clinical contraindication to catheter ablation or general anaesthetic, including adverse reaction to contrast media, intracardiac thrombus, or inadequate anticoagulation in last 6 weeks
- Moderate or greater valvular disease or presence of a prosthetic valve
- Moderate-to-severe heart failure (left ventricular ejection fraction <35% and/or NYHA class III-IV)
- Any form of cardiomyopathy
- Active infection or fever
- Severe cerebrovascular disease
- Active gastrointestinal bleeding
- Bleeding or clotting disorders, high bleeding risk, or contraindication to heparin
- Baseline serum creatinine >200umol/L
- Currently receiving or at risk of renal replacement therapy
- Uncontrolled diabetes (HbA1c ≥73 mmol/mol or HbA1c ≥64 mmol/mol with fasting glucose ≥9.2 mmol/L)
- Malignancy requiring therapy
- Life expectancy shorter than trial duration
- Pregnancy or childbearing potential without effective contraception
- Inability to provide informed consent to participate in the trial
Research Team
P
Prapa Kanagaratnam, FRCP PhD
O
Oliver S Jones, MRCP
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here