This study is a prospective, randomized controlled study to compare overall clinical outcomes between High Power Short Duration (HPSD) and standard radiofrequency (RF) ablation settings for Atrial Fibrillation (AF) ablation in the treatment of subjects with paroxysmal or persistent Atrial Fibrillation.
Pulmonary vein isolation using radiofrequency (RF) ablation is a widely used treatment strategy for atrial fibrillation. Peri-procedural complications rates are estimated at between 1.5 - 6% with the two most feared complications being stroke and atrial-esophageal fistula. The risk of these complications increases with (1) longer left atrial dwell times with greater potential for clot formation and (2) esophageal heating during delivery of radiofrequency energy. 'High-power short-duration' (HPSD) is an increasingly utilized strategy to decrease procedure duration and minimize the risk of these complications. Potential mechanisms for benefit include: (1) shorter left atrial dwell times due to more efficient lesion delivery (2) rapid, but more controlled, resistive tissue heating, which avoids deeper, passive conductive heating that can reach the esophagus and cause injury. Moreover, HPSD may improve lesion efficacy and durability due to less recover of excitability after ablation. Despite being widely used and several retrospective studies, there have been no prospective randomized trials comparing outcomes between HPSD and standard RF ablation settings. Moreover, the investigators are interested to see if a shorter procedure (less time in the left atrium) is associated with a lower rate of silent cerebral infarctions (which are occasionally seen on MRI brain post RF ablation - their clinical significance is unclear).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
Standard RF ablation settings (n=30): Maximum 35W for 20-40 seconds, per operator standard.
High power short duration RF (n=30): Maximum 50 Watts for 5-15 seconds, per operator standard.
University of California, San Francisco
San Francisco, California, United States
Ablation Duration
RF ablation duration from start of first pulmonary vein isolation lesion to end of last lesion
Time frame: During Ablation
Maximum esophageal temperature
Time frame: During ablation
Maximum esophageal temperature rise
Time frame: During ablation
Freedom from Atrial Fibrillation
\>30 secs using Ziopatch, 1 year off or on previously ineffective antiarrhythmic drugs (AADs)
Time frame: assessed at 6 and 12 months post-ablation
Freedom from Atrial Fibrillation
\>30 secs using Ziopatch, 1 year off previously ineffective antiarrhythmic drugs (AADs)
Time frame: assessed at 6 and 12 months post-ablation
% pulmonary vein pairs isolated with first encirclement
Time frame: During Ablation
Number of radiofrequency lesions required for isolation/PV
Time frame: During Ablation
Total left atrial radiofrequency (RF) time
Time frame: During Ablation
Total procedure duration
Time frame: During Ablation
Overall complication rate
Time frame: During Ablation and up to 12 month follow up assessment
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Pleurisy
Time frame: At 1 week and 1 month assessment
Pericardial effusion>1cm
Time frame: During ablation or up to 30 days post ablation
Pericardial tamponade requiring drainage
Time frame: During ablation or up to 30 days post ablation
Total saline infused
Time frame: During Ablation
Presence of asymptomatic cerebral emboli
Time frame: 1 day post-ablation