Pulmonary Vein Antrum Isolation (PVAI) Plus Scar Homogenization and Non-PV Triggers Ensure Long-term Recurrence-free Survival in Non-paroxysmal Atrial Fibrillation (TANTRA)

Texas Cardiac Arrhythmia Research Foundation

Status: Unknown

Conditions: Long-standing Persistent Atrial Fibrillation; Persistent Atrial Fibrillation

Treatments: Procedure: scar homogenization; Procedure: Pulmonary Vein Antrum Isolation; Procedure: Non-PV triggers ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT01672138

TANTRA_TCAI

Details and patient eligibility

About

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]

Full 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.

Enrollment: 186 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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186 participants in 3 patient groups

Control

Active Comparator group

Description:

Pulmonary Vein Antrum Isolation (PVAI) + isolation of left atrial posterior wall

Treatment:

Procedure: Pulmonary Vein Antrum Isolation

Study I

Active Comparator group

Description:

PVAI+ scar homogenization

Treatment:

Procedure: scar homogenization

Procedure: Pulmonary Vein Antrum Isolation

Study II

Active Comparator group

Description:

PVAI + isolation of left atrial posterior wall + non-PV triggers ablation

Treatment:

Procedure: scar homogenization

Procedure: Pulmonary Vein Antrum Isolation

Procedure: Non-PV triggers ablation