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

Not Applicable

• Conditions: Persistent Atrial Fibrillation; Long-standing Persistent Atrial Fibrillation
• Interventions: Procedure: Pulmonary Vein Antrum Isolation; Procedure: scar homogenization; Procedure: Non-PV triggers ablation

• Registration Number: NCT01672138
• Lead Sponsor: Texas Cardiac Arrhythmia Research Foundation

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.

Study Timeline

• Study First Submitted: 2012-08-21
• Study First Submitted QC: 2012-08-21
• Study First Posted: 2012-08-24
• Study Start: 2013-02
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-14
• Last Update Posted: 2018-11-16
• Primary Completion: 2019-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 186

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study II	scar homogenization	PVAI + isolation of left atrial posterior wall + non-PV triggers ablation
Control	Pulmonary Vein Antrum Isolation	Pulmonary Vein Antrum Isolation (PVAI) + isolation of left atrial posterior wall
Study II	Pulmonary Vein Antrum Isolation	PVAI + isolation of left atrial posterior wall + non-PV triggers ablation
Study I	Pulmonary Vein Antrum Isolation	PVAI+ scar homogenization
Study II	Non-PV triggers ablation	PVAI + isolation of left atrial posterior wall + non-PV triggers ablation
Study I	scar homogenization	PVAI+ scar homogenization

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Improvement in quality of life	3 years	Improvement in quality of life

Trial Locations

Locations (2)

St. david's medical Center; 🇺🇸 Austin, Texas, United States

Texas Cardiac arrhythmia Institute, St. David's Hospital; 🇺🇸 Austin, Texas, United States