A Phase 3 interventional study of radiofrequency catheter ablation in Atrial Fibrillation, sponsored by Texas Cardiac Arrhythmia Research Foundation. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-04-25.
Sponsored by Texas Cardiac Arrhythmia Research Foundation · Phase 3, Interventional, and Treatment
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).
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.
3,870 studies on the registry are indexed under Atrial Fibrillation; 923 are open to participants now.
This study's planned enrollment of 120 is below the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Texas Cardiac Arrhythmia Research Foundation is the lead sponsor of 36 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
ablation at sources guided by FIRMap (using RhythmView™ Workstation from TOPERA) Intervention: AF ablation
Procedure: radiofrequency catheter ablation
ablation at sources guided by FIRMap (using RhythmView™ Workstation from TOPERA) + conventional pulmonary vein antrum isolation (PVAI) Intervention: AF ablation
Procedure: radiofrequency catheter ablation
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)
Also known as: RFCA
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.
Time frame: 1 year post-ablation
Procedural complications
complications associated with prolonged use of radiofrequency (RF) energy such as atrioesophageal fistula, perforation, cardiac tamponade, major hemorrhagic events
Time frame: 48 hours
Acute success
AF termination, organization into AT or ≥10 % slowing
Time frame: Intra-procedural
This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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Texas Cardiac Arrhythmia Research Foundation