Outcome of Different Ablation Strategies In Persistent and Long-Standing Persistent Atrial Fibrillation (OASIS)
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| ClinicalTrials.gov Identifier: NCT02533843 |
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Recruitment Status :
Completed
First Posted : August 27, 2015
Last Update Posted : April 25, 2018
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Atrial Fibrillation | Procedure: radiofrequency catheter ablation | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 120 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Outcome of Different Ablation Strategies In Persistent and Long-Standing Persistent Atrial Fibrillation |
| Study Start Date : | April 2014 |
| Actual Primary Completion Date : | March 2016 |
| Actual Study Completion Date : | July 2017 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Arm I
ablation at sources guided by FIRMap (using RhythmView™ Workstation from TOPERA) Intervention: AF ablation
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Procedure: radiofrequency catheter ablation
Radiofrequency catheter ablation of atrial fibrillation with or without being guided by FIRMap (using RhythmView™ Workstation from TOPERA)
Other Name: RFCA |
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Active Comparator: Arm II
ablation at sources guided by FIRMap (using RhythmView™ Workstation from TOPERA) + conventional pulmonary vein antrum isolation (PVAI) Intervention: AF ablation
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Procedure: radiofrequency catheter ablation
Radiofrequency catheter ablation of atrial fibrillation with or without being guided by FIRMap (using RhythmView™ Workstation from TOPERA)
Other Name: RFCA |
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Active Comparator: Arm III
Extended PVAI plus ablation of non-PV triggers and complex fractionated atrial electrograms (CFAE) Intervention: AF ablation
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Procedure: radiofrequency catheter ablation
Radiofrequency catheter ablation of atrial fibrillation with or without being guided by FIRMap (using RhythmView™ Workstation from TOPERA)
Other Name: RFCA |
- Recurrence of atrial arrhythmia [ Time Frame: 1 year post-ablation ]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.
- Procedural complications [ Time Frame: 48 hours ]complications associated with prolonged use of radiofrequency (RF) energy such as atrioesophageal fistula, perforation, cardiac tamponade, major hemorrhagic events
- Acute success [ Time Frame: Intra-procedural ]AF termination, organization into AT or ≥10 % slowing
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02533843
| United States, Texas | |
| Texas Cardiac Arrhythmia Institute, St. david's Medical Center | |
| Austin, Texas, United States, 78705 | |
| Study Director: | Andrea Natale, MD | Texas Cardiac Arrhythmia Research Foundation |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Texas Cardiac Arrhythmia Research Foundation |
| ClinicalTrials.gov Identifier: | NCT02533843 History of Changes |
| Other Study ID Numbers: |
TCAI_OASIS |
| First Posted: | August 27, 2015 Key Record Dates |
| Last Update Posted: | April 25, 2018 |
| Last Verified: | April 2018 |
Additional relevant MeSH terms:
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Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |