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Completed

NCT Number: NCT04148664

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco

San Francisco, California, 94143, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female ≥18 years of age at their pre-operative visit.
  • Patient is scheduled to have their first AF ablation
  • Paroxysmal or persistent AF
  • 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

  • Prior AF ablation
  • Stroke or transient ischemic attack (TIA) within the previous 6 months
  • Known esophageal ulcer or gastrointestinal (GI) bleed within prior 6 months
  • Intent to perform adjunctive left atrial ablation, including posterior wall isolation, left atrial appendage isolation, mitral or other linear lesions.
  • Prior rheumatic heart disease or significant mitral stenosis
  • Mechanical mitral valve replacement
  • Long lasting persistent AF > 1 year
  • Severe left ventricular systolic dysfunction, with LV ejection fraction LVEF<35%
  • Prior left atrial appendage (LAA) occlusion device
  • Prior septal occlusion device
  • Pregnancy
  • Pacemaker, defibrillator or any contraindication to MRI

Treatment and study plan

Catheter ablation with Standard RF ablation settings

Procedure

Standard RF ablation settings (n=30):

Maximum 35W for 20-40 seconds, per operator standard.

Catheter ablation with High Power Short Duration RF ablation settings

Procedure

High power short duration RF (n=30):

Maximum 50 Watts for 5-15 seconds, per operator standard.

Primary outcomes

  1. Ablation Duration

    Time frame: During Ablation

    RF ablation duration from start of first pulmonary vein isolation lesion to end of last lesion

Secondary outcomes

  1. Maximum esophageal temperature

    Time frame: During ablation

  2. Maximum esophageal temperature rise

    Time frame: During ablation

  3. Freedom from Atrial Fibrillation

    Time frame: assessed at 6 and 12 months post-ablation

    >30 secs using Ziopatch, 1 year off or on previously ineffective antiarrhythmic drugs (AADs)

  4. Freedom from Atrial Fibrillation

    Time frame: assessed at 6 and 12 months post-ablation

    >30 secs using Ziopatch, 1 year off previously ineffective antiarrhythmic drugs (AADs)

  5. % pulmonary vein pairs isolated with first encirclement

    Time frame: During Ablation

  6. Number of radiofrequency lesions required for isolation/PV

    Time frame: During Ablation

  7. Total left atrial radiofrequency (RF) time

    Time frame: During Ablation

  8. Total procedure duration

    Time frame: During Ablation

  9. Overall complication rate

    Time frame: During Ablation and up to 12 month follow up assessment

  10. Pleurisy

    Time frame: At 1 week and 1 month assessment

  11. Pericardial effusion>1cm

    Time frame: During ablation or up to 30 days post ablation

  12. Pericardial tamponade requiring drainage

    Time frame: During ablation or up to 30 days post ablation

  13. Total saline infused

    Time frame: During Ablation

  14. Presence of asymptomatic cerebral emboli

    Time frame: 1 day post-ablation

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2022
First posted
Nov 1, 2019
Registry last updated
Aug 16, 2023

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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