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

Persistent Atrial Fibrillation Clinical Trial

— TANTRA  

Official title:

PVAI Plus Scar Homogenization and Ablation of Non-PV Triggers Ensure Long-term Recurrence-free Survival in Non-paroxysmal Atrial Fibrillation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01672138
• Other study ID #: TANTRA_TCAI
• Status: Recruiting
• Phase: N/A
• Start date: February 2013
• Est. completion date: December 2020

Study information

• Verified date: November 2018
• Source: Texas Cardiac Arrhythmia Research Foundation
• Contact: Andrea Natale, MD
• Email: dr.natale[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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]

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 186
• Est. completion date: December 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Long-standing Persistent Atrial Fibrillation
• Persistent Atrial Fibrillation
• Recurrence

Intervention

Procedure:
• Pulmonary Vein Antrum Isolation
Radio-frequency catheter ablation of pulmonary vein antrum extended to the left atrial posterior wall
• scar homogenization
PVAI + RF energy will be delivered until all abnormal potentials in the low-voltage areas are eliminated.
• Non-PV triggers ablation
PVAI + Isolation of LA posterior wall + Catheter ablation of triggers originating from extra-PV sites

Locations

Country	Name	City	State
United States	St. david's medical Center	Austin	Texas
United States	Texas Cardiac arrhythmia Institute, St. David's Hospital	Austin	Texas

Sponsors (3)

Lead Sponsor	Collaborator
Texas Cardiac Arrhythmia Research Foundation	Ospedale dell'Angelo, RCCS Monzino Hospital, Milan, Italy

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of atrial arrhythmia	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.	3 years
Secondary	Improvement in quality of life	Improvement in quality of life	3 years