Pulmonary Vein Antrum Isolation (PVAI) Plus Scar Homogenization and Non-PV Triggers Ensure Long-term Recurrence-free Survival in Non-paroxysmal Atrial Fibrillation (TANTRA)
Primary Purpose
Persistent Atrial Fibrillation, Long-standing Persistent Atrial Fibrillation
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pulmonary Vein Antrum Isolation
scar homogenization
Non-PV triggers ablation
Sponsored by
About this trial
This is an interventional treatment trial for Persistent Atrial Fibrillation focused on measuring PVAI, NPAF, Non-PV triggers
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years
- Patients undergoing first catheter ablation for drug-refractory Persistent (PerAF) or long-standing persistent AF (LSPAF)
- Ability to understand and provide signed informed consent
Exclusion Criteria:
- Previous catheter ablation or MAZE procedure in left atrium
- Reversible causes of atrial arrhythmia such as hyperthyroidism, sarcoidosis, pulmonary embolism etc
Sites / Locations
- St. david's medical CenterRecruiting
- Texas Cardiac arrhythmia Institute, St. David's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Control
Study I
Study II
Arm Description
Pulmonary Vein Antrum Isolation (PVAI) + isolation of left atrial posterior wall
PVAI+ scar homogenization
PVAI + isolation of left atrial posterior wall + non-PV triggers ablation
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Improvement in quality of life
Improvement in quality of life
Full Information
NCT ID
NCT01672138
First Posted
August 21, 2012
Last Updated
November 14, 2018
Sponsor
Texas Cardiac Arrhythmia Research Foundation
Collaborators
RCCS Monzino Hospital, Milan, Italy, Ospedale dell'Angelo, Venezia-Mestre
1. Study Identification
Unique Protocol Identification Number
NCT01672138
Brief Title
Pulmonary Vein Antrum Isolation (PVAI) Plus Scar Homogenization and Non-PV Triggers Ensure Long-term Recurrence-free Survival in Non-paroxysmal Atrial Fibrillation
Acronym
TANTRA
Official Title
PVAI Plus Scar Homogenization and Ablation of Non-PV Triggers Ensure Long-term Recurrence-free Survival in Non-paroxysmal Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 2013 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Texas Cardiac Arrhythmia Research Foundation
Collaborators
RCCS Monzino Hospital, Milan, Italy, Ospedale dell'Angelo, Venezia-Mestre
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Atrial Fibrillation, Long-standing Persistent Atrial Fibrillation
Keywords
PVAI, NPAF, Non-PV triggers
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
186 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Pulmonary Vein Antrum Isolation (PVAI) + isolation of left atrial posterior wall
Arm Title
Study I
Arm Type
Active Comparator
Arm Description
PVAI+ scar homogenization
Arm Title
Study II
Arm Type
Active Comparator
Arm Description
PVAI + isolation of left atrial posterior wall + non-PV triggers ablation
Intervention Type
Procedure
Intervention Name(s)
Pulmonary Vein Antrum Isolation
Other Intervention Name(s)
PVAI
Intervention Description
Radio-frequency catheter ablation of pulmonary vein antrum extended to the left atrial posterior wall
Intervention Type
Procedure
Intervention Name(s)
scar homogenization
Intervention Description
PVAI + RF energy will be delivered until all abnormal potentials in the low-voltage areas are eliminated.
Intervention Type
Procedure
Intervention Name(s)
Non-PV triggers ablation
Intervention Description
PVAI + Isolation of LA posterior wall + Catheter ablation of triggers originating from extra-PV sites
Primary Outcome Measure Information:
Title
Recurrence of atrial arrhythmia
Description
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.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Improvement in quality of life
Description
Improvement in quality of life
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 years
Patients undergoing first catheter ablation for drug-refractory Persistent (PerAF) or long-standing persistent AF (LSPAF)
Ability to understand and provide signed informed consent
Exclusion Criteria:
Previous catheter ablation or MAZE procedure in left atrium
Reversible causes of atrial arrhythmia such as hyperthyroidism, sarcoidosis, pulmonary embolism etc
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea Natale, MD
Email
dr.natale@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mitra Mohanty, MD
Email
mitra.mohanty@stdavids.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Natale, MD
Organizational Affiliation
TCAI
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. david's medical Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mitra Mohanty, MD
Phone
512-544-8198
Email
mitra1989@gmail.com
Email
mitra1989@gmail.com
Facility Name
Texas Cardiac arrhythmia Institute, St. David's Hospital
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Natale, MD
Phone
512-544-8186
Email
dr.natale@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Pulmonary Vein Antrum Isolation (PVAI) Plus Scar Homogenization and Non-PV Triggers Ensure Long-term Recurrence-free Survival in Non-paroxysmal Atrial Fibrillation
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