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

August 14, 2023 updated by: University of California, San Francisco

SHORT-AF: A Randomized 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • University of California, San Francisco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard Catheter Settings
Group 1 - Standard RF ablation settings
Procedure: Catheter ablation with Standard RF ablation settings

Standard RF ablation settings (n=30):

Maximum 35W for 20-40 seconds, per operator standard.
Experimental: High Power Short Duration (HPSD)
Group 2 - High power short duration RF
Procedure: Catheter 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ablation Duration
Time Frame: During Ablation
RF ablation duration from start of first pulmonary vein isolation lesion to end of last lesion
During Ablation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum esophageal temperature
Time Frame: During ablation
During ablation
Maximum esophageal temperature rise
Time Frame: During ablation
During ablation
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)
assessed at 6 and 12 months post-ablation
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)
assessed at 6 and 12 months post-ablation
% pulmonary vein pairs isolated with first encirclement
Time Frame: During Ablation
During Ablation
Number of radiofrequency lesions required for isolation/PV
Time Frame: During Ablation
During Ablation
Total left atrial radiofrequency (RF) time
Time Frame: During Ablation
During Ablation
Total procedure duration
Time Frame: During Ablation
During Ablation
Overall complication rate
Time Frame: During Ablation and up to 12 month follow up assessment
During Ablation and up to 12 month follow up assessment
Pleurisy
Time Frame: At 1 week and 1 month assessment
At 1 week and 1 month assessment
Pericardial effusion>1cm
Time Frame: During ablation or up to 30 days post ablation
During ablation or up to 30 days post ablation
Pericardial tamponade requiring drainage
Time Frame: During ablation or up to 30 days post ablation
During ablation or up to 30 days post ablation
Total saline infused
Time Frame: During Ablation
During Ablation
Presence of asymptomatic cerebral emboli
Time Frame: 1 day post-ablation
1 day post-ablation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Edward P Gerstenfeld, MD, Chief of Cardiac Electrophysiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 3, 2019

Primary Completion (Actual)

December 1, 2020

Study Completion (Actual)

December 30, 2022

Study Registration Dates

First Submitted

October 30, 2019

First Submitted That Met QC Criteria

October 31, 2019

First Posted (Actual)

November 1, 2019

Study Record Updates

Last Update Posted (Actual)

August 16, 2023

Last Update Submitted That Met QC Criteria

August 14, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHORT-AF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We are open to collaboration but do not plan to give our data to others.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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