Outcome of Different Ablation Strategies In Persistent and Long-Standing Persistent Atrial Fibrillation (OASIS)
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
radiofrequency catheter ablation
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
- Age: ≥ 18 years
- Patients presenting with persistent or long-standing persistent AF
- Undergoing first ablation procedure
- Ability to provide written informed consent
Exclusion Criteria:
- Reversible causes of atrial arrhythmia such as hyperthyroidism, pneumonia, pulmonary embolism, sarcoidosis and excessive alcohol consumption
- Prior ablation procedures
- Pregnancy
Sites / Locations
- Texas Cardiac Arrhythmia Institute, St. david's Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Arm I
Arm II
Arm III
Arm Description
ablation at sources guided by FIRMap (using RhythmView™ Workstation from TOPERA) Intervention: AF ablation
ablation at sources guided by FIRMap (using RhythmView™ Workstation from TOPERA) + conventional pulmonary vein antrum isolation (PVAI) Intervention: AF ablation
Extended PVAI plus ablation of non-PV triggers and complex fractionated atrial electrograms (CFAE) Intervention: AF ablation
Outcomes
Primary Outcome Measures
Recurrence of atrial arrhythmia
Any episode of AF/AT > 30 sec will be considered as a recurrence. Episodes that occur during the first 2 months after the procedure (blanking period) will not be considered as recurrence.
Secondary Outcome Measures
Procedural complications
complications associated with prolonged use of radiofrequency (RF) energy such as atrioesophageal fistula, perforation, cardiac tamponade, major hemorrhagic events
Acute success
AF termination, organization into AT or ≥10 % slowing
Full Information
NCT ID
NCT02533843
First Posted
December 5, 2014
Last Updated
April 23, 2018
Sponsor
Texas Cardiac Arrhythmia Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT02533843
Brief Title
Outcome of Different Ablation Strategies In Persistent and Long-Standing Persistent Atrial Fibrillation
Acronym
OASIS
Official Title
Outcome of Different Ablation Strategies In Persistent and Long-Standing Persistent Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
July 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Texas Cardiac Arrhythmia Research Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Specific Aim: This prospective randomized study aims to compare the impact of three different catheter ablation approaches on long-term procedure outcome in terms of arrhythmia recurrence in persistent (PeAF) and long-standing persistent atrial fibrillation (LSPAF) patients. The three strategies to be evaluated are 1) ablation at sources guided by FIRMap (using RhythmView™ Workstation from TOPERA), 2) ablation at sources guided by FIRMap + conventional pulmonary vein antrum isolation (PVAI) and 3) Extended PVAI plus ablation of non-PV triggers and complex fractionated atrial electrograms (CFAE).
Detailed Description
Specific Aim: This prospective randomized study aims to compare the impact of three different catheter ablation approaches on long-term procedure outcome in terms of arrhythmia recurrence in persistent (PeAF) and long-standing persistent atrial fibrillation (LSPAF) patients. The three strategies to be evaluated are 1) ablation at sources guided by FIRMap (using RhythmView™ Workstation from TOPERA), 2) ablation at sources guided by FIRMap + conventional pulmonary vein antrum isolation (PVAI) and 3) Extended PVAI plus ablation of non-PV triggers and complex fractionated atrial electrograms (CFAE).
Hypothesis: Extended PVAI plus ablation of non-PV triggers and CFAE results in better long-term procedure outcome in PeAF and LSPAF patients.
Background: The limited success rate of conventional ablation approaches in LSPAF has led to the search for the ideal ablation strategy (1). The main problem in the settings of PeAF and LSPAF is the lack of information on the best targets to ablate to achieve freedom from arrhythmia (2). Some strategies aim at elimination of AF triggers; some solely target CFAE for atrial substrate modification whereas others elect for isolation of PVs plus posterior wall along with ablation of non-PV triggers demonstrated by high-dose isoproterenol challenge with or without CFAEs. (2). The last option has been shown to be the best option so far in improving the freedom from AF at long-term follow-up (2, 3).
Recently Narayan et al, by using a computational mapping system that identifies 'rotors' (organized reentrant circuits or focal impulses), were able to achieve a success rate of 82.4% following ablation of rotors plus PVAI, at a median follow-up of 273 days, in a primarily paroxysmal AF population (4). The results of this study are promising and need to be tested in patients with PeAF and LSPAF.
Objective: To compare the long-term efficacy and safety of different ablation approaches in PeAF and LSPAF patients.
Study Design: This prospective study will enroll 120 consecutive PeAF/LSPAF patients and consenting patients will be randomized to any of the 3 groups (40 per group); Group 1: ablation at sources guided by FIRMap (using RhythmView™ Workstation from TOPERA) Group 2: ablation at sources guided by FIRMap + conventional pulmonary vein antrum isolation (PVAI) Group 3: Extended PVAI plus ablation of non-PV triggers and complex fractionated atrial electrograms (CFAE) Patients will be randomized to different treatment groups after the risks and benefits of each one are discussed in detail with them.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm I
Arm Type
Active Comparator
Arm Description
ablation at sources guided by FIRMap (using RhythmView™ Workstation from TOPERA) Intervention: AF ablation
Arm Title
Arm II
Arm Type
Active Comparator
Arm Description
ablation at sources guided by FIRMap (using RhythmView™ Workstation from TOPERA) + conventional pulmonary vein antrum isolation (PVAI) Intervention: AF ablation
Arm Title
Arm III
Arm Type
Active Comparator
Arm Description
Extended PVAI plus ablation of non-PV triggers and complex fractionated atrial electrograms (CFAE) Intervention: AF ablation
Intervention Type
Procedure
Intervention Name(s)
radiofrequency catheter ablation
Other Intervention Name(s)
RFCA
Intervention Description
Radiofrequency catheter ablation of atrial fibrillation with or without being guided by FIRMap (using RhythmView™ Workstation from TOPERA)
Primary Outcome Measure Information:
Title
Recurrence of atrial arrhythmia
Description
Any episode of AF/AT > 30 sec will be considered as a recurrence. Episodes that occur during the first 2 months after the procedure (blanking period) will not be considered as recurrence.
Time Frame
1 year post-ablation
Secondary Outcome Measure Information:
Title
Procedural complications
Description
complications associated with prolonged use of radiofrequency (RF) energy such as atrioesophageal fistula, perforation, cardiac tamponade, major hemorrhagic events
Time Frame
48 hours
Title
Acute success
Description
AF termination, organization into AT or ≥10 % slowing
Time Frame
Intra-procedural
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age: ≥ 18 years
Patients presenting with persistent or long-standing persistent AF
Undergoing first ablation procedure
Ability to provide written informed consent
Exclusion Criteria:
Reversible causes of atrial arrhythmia such as hyperthyroidism, pneumonia, pulmonary embolism, sarcoidosis and excessive alcohol consumption
Prior ablation procedures
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Natale, MD
Organizational Affiliation
Texas Cardiac Arrhythmia Research Foundation
Official's Role
Study Director
Facility Information:
Facility Name
Texas Cardiac Arrhythmia Institute, St. david's Medical Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
30144981
Citation
Mohanty S, Gianni C, Trivedi C, Metz T, Bai R, Al-Ahmad A, Bailey S, Burkhardt JD, Gallinghouse GJ, Horton R, Hranitzky PM, Sanchez JE, Di Biase L, Natale A. Impact of rotor ablation in non-paroxysmal AF patients: Findings from the per-protocol population of the OASIS trial at long-term follow-up. Am Heart J. 2018 Nov;205:145-148. doi: 10.1016/j.ahj.2018.05.021. Epub 2018 Jul 31.
Results Reference
derived
PubMed Identifier
27163758
Citation
Mohanty S, Gianni C, Mohanty P, Halbfass P, Metz T, Trivedi C, Deneke T, Tomassoni G, Bai R, Al-Ahmad A, Bailey S, Burkhardt JD, Gallinghouse GJ, Horton R, Hranitzky PM, Sanchez JE, Di Biase L, Natale A. Impact of Rotor Ablation in Nonparoxysmal Atrial Fibrillation Patients: Results From the Randomized OASIS Trial. J Am Coll Cardiol. 2016 Jul 19;68(3):274-282. doi: 10.1016/j.jacc.2016.04.015. Epub 2016 May 6.
Results Reference
derived
Learn more about this trial
Outcome of Different Ablation Strategies In Persistent and Long-Standing Persistent Atrial Fibrillation
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