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

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).

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Procedure: radiofrequency catheter ablation

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 Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78705
      • Texas Cardiac Arrhythmia Institute, St. david's Medical Center

Participation Criteria

Eligibility Criteria

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

Description

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

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: 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 Names: 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 Names: 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 Names: RFCA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year post-ablation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural complications	complications associated with prolonged use of radiofrequency (RF) energy such as atrioesophageal fistula, perforation, cardiac tamponade, major hemorrhagic events	48 hours
Acute success	AF termination, organization into AT or ≥10 % slowing	Intra-procedural

Collaborators and Investigators

• Sponsor: Texas Cardiac Arrhythmia Research Foundation
• Investigators: Study Director: Andrea Natale, MD, Texas Cardiac Arrhythmia Research Foundation

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: December 5, 2014
• First Submitted That Met QC Criteria: August 24, 2015
• First Posted (Estimate): August 27, 2015

Study Record Updates

• Last Update Posted (Actual): April 25, 2018
• Last Update Submitted That Met QC Criteria: April 23, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: TCAI_OASIS