Catheter Ablation for persistent atrial fibrillation: a multicentre randomised trial PVI vs PVI with posterior left atrial wall isolation (PWI)
Number of patients recruited by Canberra Heart Rhythm: 4
Multicentre international randomised trial, blinded.
Target number of 338 subjects has been reached in March 2021 and recruitment was stopped.
To compare PVI vs PVI with PWI in patients with persistent atrial fibrillation in: decrease AF occurrence, no increase periprocedural complications within the next 12 months.
Loop recorder inserted at the time if possibleotherwise, 7 day Holter at 3, 6, 9, 12 months
- Patients undergoing a first-time ablation procedure for AF
- Persistent AF
- Persistent AF will be defined as a sustained episode lasting >7 days and less than three years (or required chemical or electrical DCCV between 2-7 days)
- Patients with symptomatic AF that is refractory to at least one antiarrhythmic medication
- Symptomatic patients are those who have been aware of their AF at anytime within the last 5 years prior to enrollment. Symptoms may include, but are Not restricted to, palpitations, shortness of breath, chest pain, fatigue, left ventricular dysfunction, or other symptoms, or any combination of the above
- At least one episode of persistent AF must have been documented by ECG, holter, loop recorder, telemetry, trans telephonic monitoring (TTM), orimplantable device within last 2 years of enrollment in this investigation
- Paroxysmal AF. Patients with permanent or chronic persistent AF > 18months
- AF secondary to reversible cause such as thyrotoxicosis or severe untreated sleep apnoea
- Patients with contra-indication to anticoagulation
- Creatinine >200, End stage renal or hepatic failure
- Severe valvular heart disease or cyanotic congenital heart disease
- Patients for whom cardioversion or sinus rhythm will never be attempted/pursued
- Patients with left atrial size ≥ 60 mm (2D echocardiography, parasternal long axis view)
- Diagnosis of hypertrophic cardiomyopathy