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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

186 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2020-12-31

Brief Summary

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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\]

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Detailed Description

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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.

Conditions

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Persistent Atrial Fibrillation Long-standing Persistent Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

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

Group Type ACTIVE_COMPARATOR

Pulmonary Vein Antrum Isolation

Intervention Type PROCEDURE

Radio-frequency catheter ablation of pulmonary vein antrum extended to the left atrial posterior wall

Study I

PVAI+ scar homogenization

Group Type ACTIVE_COMPARATOR

Pulmonary Vein Antrum Isolation

Intervention Type PROCEDURE

Radio-frequency catheter ablation of pulmonary vein antrum extended to the left atrial posterior wall

scar homogenization

Intervention Type PROCEDURE

PVAI + RF energy will be delivered until all abnormal potentials in the low-voltage areas are eliminated.

Study II

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

Group Type ACTIVE_COMPARATOR

Pulmonary Vein Antrum Isolation

Intervention Type PROCEDURE

Radio-frequency catheter ablation of pulmonary vein antrum extended to the left atrial posterior wall

scar homogenization

Intervention Type PROCEDURE

PVAI + RF energy will be delivered until all abnormal potentials in the low-voltage areas are eliminated.

Non-PV triggers ablation

Intervention Type PROCEDURE

PVAI + Isolation of LA posterior wall + Catheter ablation of triggers originating from extra-PV sites

Interventions

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Pulmonary Vein Antrum Isolation

Radio-frequency catheter ablation of pulmonary vein antrum extended to the left atrial posterior wall

Intervention Type PROCEDURE

scar homogenization

PVAI + RF energy will be delivered until all abnormal potentials in the low-voltage areas are eliminated.

Intervention Type PROCEDURE

Non-PV triggers ablation

PVAI + Isolation of LA posterior wall + Catheter ablation of triggers originating from extra-PV sites

Intervention Type PROCEDURE

Other Intervention Names

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PVAI

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No