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

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

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]

Study Overview

• Status: Unknown
• Conditions: Persistent Atrial Fibrillation; Long-standing Persistent Atrial Fibrillation
• Intervention / Treatment: Procedure: Pulmonary Vein Antrum Isolation; Procedure: scar homogenization; Procedure: Non-PV triggers ablation

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 Type: Interventional
• Enrollment (Anticipated): 186
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78705
      • Recruiting
      • St. David's Medical Center
      • Contact: Mitra Mohanty, MD; Phone Number: 512-544-8198; Email: mitra1989@gmail.com
      • Contact: Email: mitra1989@gmail.com
    • Austin, Texas, United States, 78705
      • Recruiting
      • Texas Cardiac arrhythmia Institute, St. David's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; Pulmonary Vein Antrum Isolation (PVAI) + isolation of left atrial posterior wall	Procedure: Pulmonary Vein Antrum Isolation; Radio-frequency catheter ablation of pulmonary vein antrum extended to the left atrial posterior wall; Other Names: PVAI
Active Comparator: Study I; PVAI+ scar homogenization	Procedure: Pulmonary Vein Antrum Isolation; Radio-frequency catheter ablation of pulmonary vein antrum extended to the left atrial posterior wall; Other Names: PVAI; Procedure: scar homogenization; PVAI + RF energy will be delivered until all abnormal potentials in the low-voltage areas are eliminated.
Active Comparator: Study II; PVAI + isolation of left atrial posterior wall + non-PV triggers ablation	Procedure: Pulmonary Vein Antrum Isolation; Radio-frequency catheter ablation of pulmonary vein antrum extended to the left atrial posterior wall; Other Names: PVAI; Procedure: scar homogenization; PVAI + RF energy will be delivered until all abnormal potentials in the low-voltage areas are eliminated.; Procedure: Non-PV triggers ablation; PVAI + Isolation of LA posterior wall + Catheter ablation of triggers originating from extra-PV sites

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in quality of life	Improvement in quality of life	3 years

Collaborators and Investigators

• Sponsor: Texas Cardiac Arrhythmia Research Foundation
• Collaborators: RCCS Monzino Hospital, Milan, Italy; Ospedale dell'Angelo, Venezia-Mestre

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2013
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: August 21, 2012
• First Submitted That Met QC Criteria: August 21, 2012
• First Posted (Estimate): August 24, 2012

Study Record Updates

• Last Update Posted (Actual): November 16, 2018
• Last Update Submitted That Met QC Criteria: November 14, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: PVAI; NPAF; Non-PV triggers
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Disease Attributes; Arrhythmias, Cardiac; Atrial Fibrillation; Recurrence
• Other Study ID Numbers: TANTRA_TCAI