Atrial Fibrillation
Conditions
Keywords
ablation
Brief summary
The objective of this study is to compare the efficacy of three different ablation strategies in patients with persistent AF: 1. PV antral isolation alone (PVAI) 2. PV antral isolation plus ablation of drivers (PVAI+drivers) 3. PV antral isolation plus isolation of posterior wall (PVAI+box) All three strategies will employ contemporary catheter ablation technology using more efficient open irrigated tip cooling and contact force sensing.
Interventions
PROCEDUREWide Circumferential Pulmonary Vein Antrum Isolation (PVAI)
Standard PVI
PROCEDUREPulmonary Vein Antrum Isolation Plus Driver Ablation (PVAI+drivers)
Standard PVI + Ablation of drivers in LA and RA
PROCEDUREPulmonary Vein Antrum Isolation Plus Box Isolation of Posterior Wall (PVAI+box)
Standard PVI + Electrical isolation of the posterior wall of the left atrium
Sponsors
McGill University Health Centre/Research Institute of the McGill University Health Centre
Montreal Heart Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients 18 years of age or older 2. Patients undergoing first-time ablation procedure for AF 3. Patients with persistent AF defined as a sustained episode more than 3 months but less than three years 4. Patients with symptomatic AF - symptomatic patients are those who have been aware of their AF at any time within the last 5 years prior to enrolment. 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 5. Patients whose AF has been refractory to at least one antiarrhythmic drug 6. At least one episode of AF must have been documented by ECG, holter, loop recorder, telemetry, trans-telephonic monitor or implanted device within the last 2 years from enrolment 7. Patients must be able and willing to provide written informed consent to participate in the study
Exclusion criteria
1. Patients with paroxysmal AF (no episodes lasting \> 7 days) 2. Patients with early persistent AF, sustained episode ≤ 3 months 3. Patients with very long lasting persistent AF (episodes lasting \> 3 years) 4. Patients with CHA2DS2-VASc score of 0. 5. Patients for whom cardioversion or sinus rhythm will never be attempted/pursued 6. Patients with AF felt to be secondary to an obvious reversible cause 7. Patients with contraindication to oral anticoagulation or systemic anticoagulation with heparin 8. Patients with left atrial diameter \> 60 mm in the parasternal long axis view 9. Patients who are pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Freedom from documented atrial arrhythmia ≥ 30 seconds at 18 months after one ablation procedure on or off antiarrhythmic medications (AAM). | 18 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from documented AF > 30 seconds at 18 months after one procedure on or off AAM | 18 months | — |
| Freedom from documented AF > 30 seconds at 18 months after one or more procedures on or off AAM | 18 months | — |
| Freedom from documented atrial arrhythmia > 30 seconds at 18 months after one or more procedures on or off AAM | 18 months | — |
| Freedom from documented AF > 30 seconds at 18 months after one procedure off AAM | 18 months | — |
| Freedom from documented atrial arrhythmia > 30 seconds at 18 months after one procedure off AAM | 18 months | — |
| Freedom from documented AF > 30 seconds at 18 months after one or more procedures off AAM | 18 months | — |
| Freedom from documented atrial arrhythmia > 30 seconds after one or more procedures off AAM | 18 months | — |
| Freedom from documented symptomatic AF > 30 seconds at 18 months after one procedure on or off AAM | 18 months | — |
| Freedom from documented symptomatic atrial arrhythmia > 30 seconds after one procedure on or off AAM | 18 months | — |
| Each of the above success measures stratified by CHA2DS2-VASc score | 18 months | — |
| Incidence of peri-procedural complications including stroke, PV stenosis, cardiac perforation, esophageal injury, phrenic nerve palsy, and death | 18 months | — |
| Procedure duration | 18 months | — |
| Fluoroscopy time (dose) | 18 months | — |
| Radiofrequency time | 18 months | — |
| Number of repeat procedures | 18 months | — |
| Effect of each strategy on AF cycle length changes and AF termination | 18 months | — |
| Correlation of acute AF termination on long-term procedural outcome | 18 months | — |
| Quality of life measurements during follow-up using AFEQT questionnaire | 6-12-18 months | AFEQT questionnaires will be used at baseline, 6, 12 and 18 months |
| Quality of life measurements during follow-up using SF12 questionnaires | 6-12-18 months | SF36 questionnaires will be used at baseline, 6, 12 and 18 months |
| Change in AF burden post-ablation procedure (% of time in AF) | 18 months | — |
Countries
Australia, Austria, Belgium, Canada, France, Italy, Japan, Spain, United States
Contacts
PRINCIPAL_INVESTIGATORAtul Verma, Dr.
McGill University Health Centre/Research Institute of the McGill University Health Centre
PRINCIPAL_INVESTIGATORLaurent Macle, Dr.
Montreal Heart Institute
Outcome results
None listed