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Outcome of Different Ablation Strategies In Persistent and Long-Standing Persistent Atrial Fibrillation (OASIS)

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ClinicalTrials.gov Identifier: NCT02533843
Recruitment Status : Completed
First Posted : August 27, 2015
Last Update Posted : April 25, 2018
Sponsor:
Information provided by (Responsible Party):
Texas Cardiac Arrhythmia Research Foundation

Study Description
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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).

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Procedure: radiofrequency catheter ablation Phase 3

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.

Study Design
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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

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Arm I
ablation at sources guided by FIRMap (using RhythmView™ Workstation from TOPERA) Intervention: AF ablation
 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
Active Comparator: Arm II
ablation at sources guided by FIRMap (using RhythmView™ Workstation from TOPERA) + conventional pulmonary vein antrum isolation (PVAI) Intervention: AF ablation
 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
Active Comparator: Arm III
Extended PVAI plus ablation of non-PV triggers and complex fractionated atrial electrograms (CFAE) Intervention: AF ablation
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. Acute success [ Time Frame: Intra-procedural ]
    AF termination, organization into AT or ≥10 % slowing


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age: ≥ 18 years
  2. Patients presenting with persistent or long-standing persistent AF
  3. Undergoing first ablation procedure
  4. Ability to provide written informed consent

Exclusion Criteria:

  1. Reversible causes of atrial arrhythmia such as hyperthyroidism, pneumonia, pulmonary embolism, sarcoidosis and excessive alcohol consumption
  2. Prior ablation procedures
  3. Pregnancy
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Texas
Texas Cardiac Arrhythmia Institute, St. david's Medical Center
Austin, Texas, United States, 78705
Sponsors and Collaborators
Texas Cardiac Arrhythmia Research Foundation
Investigators
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Study Director: Andrea Natale, MD Texas Cardiac Arrhythmia Research Foundation
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Texas Cardiac Arrhythmia Research Foundation
ClinicalTrials.gov Identifier: NCT02533843    
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