A Trial of High Power-Short Duration Versus Standard Power-Long Duration Radiofrequency Ablation for Treatment of Atrial Fibrillation

Not Applicable

Completed

• Conditions: Atrial Fibrillation; Atrial Fibrillation Paroxysmal; Atrial Fibrillation, Persistent
• Interventions: Procedure: Catheter ablation with Standard RF ablation settings; Procedure: Catheter ablation with High Power Short Duration RF ablation settings

• Registration Number: NCT04148664
• Lead Sponsor: University of California, San Francisco

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).

Study Timeline

• Study First Submitted: 2019-10-30
• Study First Submitted QC: 2019-10-31
• Study First Posted: 2019-11-01
• Study Start: 2019-12-03
• Primary Completion: 2020-12-01
• Study Completion: 2022-12-30
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-14
• Last Update Posted: 2023-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Catheter Settings	Catheter ablation with Standard RF ablation settings	Group 1 - Standard RF ablation settings
High Power Short Duration (HPSD)	Catheter ablation with High Power Short Duration RF ablation settings	Group 2 - High power short duration RF

Primary Outcome Measures

Name	Time	Method
Ablation Duration	During Ablation	RF ablation duration from start of first pulmonary vein isolation lesion to end of last lesion

Secondary Outcome Measures

Name	Time	Method
Pericardial tamponade requiring drainage	During ablation or up to 30 days post ablation
Total saline infused	During Ablation
Total left atrial radiofrequency (RF) time	During Ablation
Freedom from Atrial Fibrillation	assessed at 6 and 12 months post-ablation	\>30 secs using Ziopatch, 1 year off previously ineffective antiarrhythmic drugs (AADs)
Maximum esophageal temperature rise	During ablation
% pulmonary vein pairs isolated with first encirclement	During Ablation
Maximum esophageal temperature	During ablation
Total procedure duration	During Ablation
Number of radiofrequency lesions required for isolation/PV	During Ablation
Overall complication rate	During Ablation and up to 12 month follow up assessment
Pleurisy	At 1 week and 1 month assessment
Pericardial effusion>1cm	During ablation or up to 30 days post ablation
Presence of asymptomatic cerebral emboli	1 day post-ablation

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States