None listed
Conditions
Brief summary
Catheter based atrial fibrillation (AF) ablation is an effective treatment option for AF patients who are intolerant or who do not respond to medications. Ablation using radiofrequency energy in the back wall (posterior wall) of the left atrium is associated with a risk of causing esophageal thermal injury (ETI). Current strategies to minimise the risk of ETI include reducing the ablation power setting to 25 Watts and using an esophageal temperature probe. Recent studies have shown that the use of high power (50 Watts) but shorter duration (HPSD) ablation results in more effective AF lesion formation with no increase in complication rates, including rates of ETI. This single center randomised trial is designed to compare HPSD ablation to standard lower power longer duration (LPLD) ablation and the effects on ETI rates. Patients with paroxysmal or persistent AF undergoing their first AF ablation procedure at the Alfred Hospital will be recruited and randomised into the 2 treatment arms. A multisensor esophageal temperature probe will be used in all cases. All participants will undergo an endoscopy within 24 hours after their ablation to look for evidence of ETI, with 12 months of follow up after. We expect the study to show that HPSD ablation is non- inferior to LPLD ablation in terms of ETI, with significantly lower procedural times and exposure to radation
Interventions
Patients will undergo AF ablation procedure as clinically indicated. This procedure is done under general anaesthesia by an interventional cardiac electrophysiologist. Access will be gained via right femoral vein with 4 sheaths placed. Diagnostic catheters are placed in the Coronary sinus and His bundle. Transesophageal echocardiogram is performed to exclude cardiac thrombus and to guide transseptal puncture. A circular mapping catheter and ablation catheter are placed in the left atrium via lon
Patients will undergo AF ablation procedure as clinically indicated. This procedure is done under general anaesthesia by an interventional cardiac electrophysiologist. Access will be gained via right femoral vein with 4 sheaths placed. Diagnostic catheters are placed in the Coronary sinus and His bundle. Transesophageal echocardiogram is performed to exclude cardiac thrombus and to guide transseptal puncture. A circular mapping catheter and ablation catheter are placed in the left atrium via long sheaths following transseptal puncture access. The mapping catheter will be used to create a 3D map of the left atrium, which is integrated with pre-procedural CT images of the left atrium. Radiofreqeuency energy is applied using the ablation catheter to create the ablation lesions, with the aim being to perform pulmonary vein isolation. For this study, patients will be randomised to either lower power (25W) when ablating in the posterior wall of the left atrium, or high power ( 40- 50W) Ablation is terminated when target AI of 400 or LSI of 4 is achieved. A multisensor esophageal temperature probe will be used to monitor for luminal temperature rises. The typical duration for an AF ablation is 3 hours, including anaesthetic preparation time.Following the AF ablation, patients will undergo an upper gastrointestinal endoscopy procedure which is done under sedation, to look for any evidence ofesophageal thermal injury. A case report form will be used to record all intraprocedural details from the AF ablation and also findings from the post ablation endoscopy. Brain MRI will be performed day 1 following ablation to look for silent cerebral infarctions (SCIs). All patients will be followed up for 12 months after their ablation procedure. Anticoagulation is continued for at least 3 months after ablation, with cessation beyond that as per clinician decision. Anti-arrhythmic medications will be discontinued after ablation in paroxysmal AF patients, and at 3 months after ablation in persistent AF patients. Patients will be reviewed in the arrhythmia clinic at 3 and 12 months. Heart rhythm monitoring is performed either via AliveCor® electronic rhythm monitoring system, or 24 Hr holters. Follow-up 24-day holter monitoring will be performed at 3,6, 9 and 12 months. Patients will be requested to complete the AFEQT questionnaire at 6 months and 12 months
Sponsors
Alfred Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Patients aged more than / equal to 18 years old 2. Patients undergoing a first-time ablation procedure for AF 3. Patients with symptomatic AF that is refractory to at least one antiarrhythmic medication 4. Patients must be able and willing to provide written informed consent to participate in this investigation 5. Patients must be willing and able to comply with all peri-ablation and follow- up requirements
Exclusion criteria
1. Patients with long-standing persistent AF - defined as a sustained episode lasting more than 3 years 2. Patients for whom cardioversion or sinus rhythm will never be attempted/pursued 3. Patients with AF felt to be secondary to an obvious reversible cause 4. Left atrium thrombus 5. Previous AF ablation 6. Severe valvular heart disease 7. Known esophageal disorder / GORD 8. Patients with contraindications for taking anticoagulation therapy 9. Patients with creatinine >200 ml/min or end stage renal / liver impairment 10. Pregnancy 11. Diagnosis of hypertrophic cardiomyopathy.
Outcome results
None listed