University of California, San Francisco
San Francisco, California, 94143, United States
NCT Number: NCT04148664
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
San Francisco, California, 94143, United States
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: During Ablation
RF ablation duration from start of first pulmonary vein isolation lesion to end of last lesion
Time frame: During ablation
Time frame: During ablation
Time frame: assessed at 6 and 12 months post-ablation
>30 secs using Ziopatch, 1 year off or on previously ineffective antiarrhythmic drugs (AADs)
Time frame: assessed at 6 and 12 months post-ablation
>30 secs using Ziopatch, 1 year off previously ineffective antiarrhythmic drugs (AADs)
Time frame: During Ablation
Time frame: During Ablation
Time frame: During Ablation
Time frame: During Ablation
Time frame: During Ablation and up to 12 month follow up assessment
Time frame: At 1 week and 1 month assessment
Time frame: During ablation or up to 30 days post ablation
Time frame: During ablation or up to 30 days post ablation
Time frame: During Ablation
Time frame: 1 day post-ablation
University of California, San Francisco
Other
SHORT-AF: A Randomized Trial of High Power-Short Duration Versus Standard Power-Long Duration Radiofrequency Ablation for Treatment of Atrial Fibrillation
Acronym: Short-AF
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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