Long-standing Persistent Atrial Fibrillation, Persistent Atrial Fibrillation
Conditions
Keywords
PVAI, NPAF, Non-PV triggers
Brief summary
This study aims to examine the long-term success rate of catheter ablation in non-paroxysmal atrial fibrillation patients using different ablation strategies such as : (i) pulmonary vein antrum isolation (PVAI) + isolation of left atrial posterior wall, (ii) PVAI plus scar homogenization, (iii) PVAI plus isolation of posterior wall plus ablation of non-PV triggers \[ PVAI: Pulmonary Vein Antrum Isolation Non-PV triggers: Triggers arising from sites other than pulmonary veins\]
Detailed description
Back ground: Pulmonary vein antrum isolation (PVAI) as a lone procedure, is known to have limited success rate in terms of long-term recurrence-free survival in non-paroxysmal atrial fibrillation (NPAF) and additional ablations isolating extra-PV triggers seem to improve the outcome (1). The extra-PV triggers include triggers from other sites such as left atrial posterior wall, superior vena cava, interatrial septum, crista terminalis, left atrial appendage and coronary sinus (1, 2). These are known to be independent predictors of late AF recurrence following catheter ablation (3, 4, and 5). Earlier studies have demonstrated better ablation outcome in NPAF when non-PV triggers sites were isolated along with PVAI (5, 6). Moreover, Verma et al had reported high (57%) recurrence rate post-index procedure in AF patients with pre-existent scar (7). However, published data are conflicting regarding the benefits of additional substrate guided ablation (scar homogenization) compared to conventional PVAI alone strategy (8). Also, limited data is available showing a comparison of the lasting efficacy of the above three procedures when used in different combinations. Hypothesis: The combined ablation strategy including PVAI, scar homogenization and ablation of extra-PV triggers has the highest likelihood of maintaining long-term sinus rhythm in patients with NPAF.
Interventions
PROCEDURENon-PV triggers ablation
PVAI + Isolation of LA posterior wall + Catheter ablation of triggers originating from extra-PV sites
PROCEDUREPulmonary Vein Antrum Isolation
Radio-frequency catheter ablation of pulmonary vein antrum extended to the left atrial posterior wall
PROCEDUREscar homogenization
PVAI + RF energy will be delivered until all abnormal potentials in the low-voltage areas are eliminated.
Sponsors
RCCS Monzino Hospital, Milan, Italy
Ospedale dell'Angelo, Venezia-Mestre
Texas Cardiac Arrhythmia Research Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years 2. Patients undergoing first catheter ablation for drug-refractory Persistent (PerAF) or long-standing persistent AF (LSPAF) 3. Ability to understand and provide signed informed consent
Exclusion criteria
1. Previous catheter ablation or MAZE procedure in left atrium 2. Reversible causes of atrial arrhythmia such as hyperthyroidism, sarcoidosis, pulmonary embolism etc
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence of atrial arrhythmia | 3 years | Any episode of AF/AT (atrial tachycardia) longer than 30 seconds will be considered as recurrence). Episodes that occur during the first 3 months of the procedure (blanking period) will not be considered as recurrence. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in quality of life | 3 years | Improvement in quality of life |
Countries
United States
Contacts
Primary ContactAndrea Natale, MD
Backup ContactMitra Mohanty, MD
Outcome results
None listed