Clinical trial NCT04148664: A Trial of High Power-Short Duration Versus Standard Power-Long Duration Radiofrequency Ablation for Treatment of Atrial Fibrillation
Official title: SHORT-AF: A Randomized Trial of High Power-Short Duration Versus Standard Power-Long Duration Radiofrequency Ablation for Treatment of Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Atrial Fibrillation Paroxysmal
Atrial Fibrillation, Persistent
Keywords: Atrial Fibrillation
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2019-11-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Ablation Duration
timeFrame: During Ablation
Secondary outcomes:
measure: Maximum esophageal temperature
timeFrame: During ablation
measure: Maximum esophageal temperature rise
timeFrame: During ablation
measure: Freedom from Atrial Fibrillation
timeFrame: assessed at 6 and 12 months post-ablation
measure: Freedom from Atrial Fibrillation
timeFrame: assessed at 6 and 12 months post-ablation
measure: % pulmonary vein pairs isolated with first encirclement
timeFrame: During Ablation
measure: Number of radiofrequency lesions required for isolation/PV
timeFrame: During Ablation
measure: Total left atrial radiofrequency (RF) time
timeFrame: During Ablation
measure: Total procedure duration
timeFrame: During Ablation
measure: Overall complication rate
timeFrame: During Ablation and up to 12 month follow up assessment
measure: Pleurisy
timeFrame: At 1 week and 1 month assessment
measure: Pericardial effusion>1cm
timeFrame: During ablation or up to 30 days post ablation
measure: Pericardial tamponade requiring drainage
timeFrame: During ablation or up to 30 days post ablation
measure: Total saline infused
timeFrame: During Ablation
measure: Presence of asymptomatic cerebral emboli
timeFrame: 1 day post-ablation
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: Chief of Cardiac Electrophysiology
name: Edward P Gerstenfeld, MD
role: PRINCIPAL_INVESTIGATOR
References:
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