Clinical trial NCT01672138: Pulmonary Vein Antrum Isolation (PVAI) Plus Scar Homogenization and Non-PV Triggers Ensure Long-term Recurrence-free Survival in Non-paroxysmal Atrial Fibrillation
Official title: PVAI Plus Scar Homogenization and Ablation of Non-PV Triggers Ensure Long-term Recurrence-free Survival in Non-paroxysmal Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Persistent Atrial Fibrillation
Long-standing Persistent Atrial Fibrillation
Keywords: PVAI
NPAF
Non-PV triggers
Lead sponsor: Texas Cardiac Arrhythmia Research Foundation
Sponsor class: OTHER
Collaborators: name: RCCS Monzino Hospital, Milan, Italy
name: Ospedale dell'Angelo, Venezia-Mestre
First posted: 2012-08-24
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Recurrence of atrial arrhythmia
timeFrame: 3 years
Secondary outcomes:
measure: Improvement in quality of life
timeFrame: 3 years
Other outcomes:
Locations:
city: Austin
country: United States
facility: St. david's medical Center
state: Texas
city: Austin
country: United States
facility: Texas Cardiac arrhythmia Institute, St. David's Hospital
state: Texas
Study officials:
affiliation: TCAI
name: Andrea Natale, MD
role: PRINCIPAL_INVESTIGATOR
References: