None listed
Conditions
Brief summary
The purpose of this study is to ascertain whether more extensive ablation for Atrial Fibrillation is more effective than limited ablation. We hypothesise that more extensive ablation will be more effective.
Interventions
This study will be a prospective randomised control trial of patients with recurrent AF post durable pulmonary vein isolation (PVI) which investigates the utility of of empiric left atrial posterior wall, mitral isthmus, cavo-tricuspid isthmus (CTI), and superior vena cava (SVC) isolation as compared to standard of care which in this case is assumed to be left atrial posterior wall. Note that if study participants do not have durable PVI at index study procedure, the PV will be re-isolated and
This study will be a prospective randomised control trial of patients with recurrent AF post durable pulmonary vein isolation (PVI) which investigates the utility of of empiric left atrial posterior wall, mitral isthmus, cavo-tricuspid isthmus (CTI), and superior vena cava (SVC) isolation as compared to standard of care which in this case is assumed to be left atrial posterior wall. Note that if study participants do not have durable PVI at index study procedure, the PV will be re-isolated and the participants excluded from the study. The two comparison groups will be: 1) Left Atrial Posterior Wall - Control Group. 2) Combined ablation targets: Left atrial posterior wall, mitral isthmus, CTI, and SVC - Comparison group. This procedure will take approximately 2 hours, and involve ablation lines which isolate each anatomical area described. This procedure will be performed once, except in cases where recurrent AF is documented and the patient may require another procedure. The procedure will be performed under General Anaesthesia. The procedure will be completed by at least one, and usually two qualified cardiologists. Detailed procedural notes will be made which will form part of the data collection strategies for the studt.
Sponsors
Alfred Hospital
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients aged greater than 18 years old 2. Patients undergoing a second-time ablation procedure for AF 3. Durable PVI found on second procedure. 4. Persistent or paroxysmal AF - defined as a sustained episode lasting at least 7 days and less than three years (including or required chemical or electrical direct current cardioversion greater than 7 days post procedure) 5. At least one episode of recurrent AF must have been documented by electrocardiogram (ECG), holter, loop recorder, telemetry, trans telephonic monitoring (TTM), or implantable device within last 6 months of enrolment in this investigation 6. Patients must be able and willing to provide written informed consent to participate in this investigation; and 7. 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. Patients with contraindications to systemic anticoagulation with heparin or coumadin or a direct thrombin inhibitor 5. Pregnancy - will be assessed by patients informing the physicians 6. End stage renal or hepatic failure. 7. Severe valvular heart disease or cyanotic congenital heart disease. 8. Diagnosis of hypertrophic cardiomyopathy.
Outcome results
None listed