Atrial Fibrillation, Atrial Fibrillation Paroxysmal, Atrial Fibrillation, Persistent
Conditions
Keywords
Atrial Fibrillation
Brief summary
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.
Detailed description
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).
Interventions
PROCEDURECatheter ablation with Standard RF ablation settings
Standard RF ablation settings (n=30): Maximum 35W for 20-40 seconds, per operator standard.
PROCEDURECatheter ablation with High Power Short Duration RF ablation settings
High power short duration RF (n=30): Maximum 50 Watts for 5-15 seconds, per operator standard.
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
This is a multi-center prospective single-blinded randomized controlled trial. Enrollment of 60 subjects undergoing clinically-indicated AF ablation is planned with 1:1 block randomization (standard 'low power' RF settings n=30, HPSD n=30 and allowing for 10 drop-outs / consent withdrawals). Follow-up will be over 12 months.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female ≥18 years of age at their pre-operative visit. 2. Patient is scheduled to have their first AF ablation 3. Paroxysmal or persistent AF 4. Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
Exclusion criteria
1. Prior AF ablation 2. Stroke or transient ischemic attack (TIA) within the previous 6 months 3. Known esophageal ulcer or gastrointestinal (GI) bleed within prior 6 months 4. Intent to perform adjunctive left atrial ablation, including posterior wall isolation, left atrial appendage isolation, mitral or other linear lesions. 5. Prior rheumatic heart disease or significant mitral stenosis 6. Mechanical mitral valve replacement 7. Long lasting persistent AF \> 1 year 8. Severe left ventricular systolic dysfunction, with LV ejection fraction LVEF\<35% 9. Prior left atrial appendage (LAA) occlusion device 10. Prior septal occlusion device 11. Pregnancy 12. Pacemaker, defibrillator or any contraindication to MRI
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ablation Duration | During Ablation | RF ablation duration from start of first pulmonary vein isolation lesion to end of last lesion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum esophageal temperature rise | During ablation | — |
| Freedom from Atrial Fibrillation | assessed at 6 and 12 months post-ablation | \>30 secs using Ziopatch, 1 year off or on previously ineffective antiarrhythmic drugs (AADs) |
| % pulmonary vein pairs isolated with first encirclement | During Ablation | — |
| Number of radiofrequency lesions required for isolation/PV | During Ablation | — |
| Total left atrial radiofrequency (RF) time | During Ablation | — |
| Total procedure duration | During Ablation | — |
| Maximum esophageal temperature | During ablation | — |
| Pleurisy | At 1 week and 1 month assessment | — |
| Pericardial effusion>1cm | During ablation or up to 30 days post ablation | — |
| Pericardial tamponade requiring drainage | During ablation or up to 30 days post ablation | — |
| Total saline infused | During Ablation | — |
| Presence of asymptomatic cerebral emboli | 1 day post-ablation | — |
| Overall complication rate | During Ablation and up to 12 month follow up assessment | — |
Countries
United States
Outcome results
None listed