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

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ClinicalTrials.gov Identifier: NCT04148664
Recruitment Status : Recruiting
First Posted : November 1, 2019
Last Update Posted : November 1, 2019
Sponsor:
Information provided by (Responsible Party):
Edward Gerstenfeld, MD, 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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Atrial Fibrillation Paroxysmal Atrial Fibrillation, Persistent Procedure: Catheter ablation with Standard RF ablation settings Procedure: Catheter ablation with High Power Short Duration RF ablation settings Not Applicable

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, we 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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a single center prospective single-blinded randomized controlled trial. Enrolment of 50 subjects undergoing clinically-indicated AF ablation is planned with 1:1 block randomization (standard 'low power' RF settings n=20, HPSD n=20 and allowing for 10 drop-outs / consent withdrawals). Follow-up will be over 12 months.
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: SHORT-AF: A Randomized Trial of High Power-Short Duration Versus Standard Power-Long Duration Radiofrequency Ablation for Treatment of Atrial Fibrillation
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine


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=25):

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=25):

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





Primary Outcome Measures :
  1. Ablation Duration [ Time Frame: During Ablation ]
    RF ablation duration from start of first pulmonary vein isolation lesion to end of last lesion


Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04148664


Contacts
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Contact: Sara A Yogi, BA (415) 502-3803 sara.yogi@ucsf.edu
Contact: Nallely Montes, BA (415)476-8436 nallely.montes@ucsf.edu

Locations
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United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Sara A Yogi, BA    415-502-3803    sara.yogi@ucsf.edu   
Contact: Nallely Montes, BA    (415)476-8436    nallely.montes@ucsf.edu   
Principal Investigator: Edward P Gerstenfeld, MD         
Sub-Investigator: Aleksandr Voskoboinik         
Sub-Investigator: Sung I Im         
Sub-Investigator: William P Dillon, MD         
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Edward P Gerstenfeld, MD Chief of Cardiac Electrophysiology

Publications:

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Responsible Party: Edward Gerstenfeld, MD, Chief of Cardiac Electrophysiology, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04148664     History of Changes
Other Study ID Numbers: SHORT-AF
First Posted: November 1, 2019    Key Record Dates
Last Update Posted: November 1, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Small single center randomized interventional study. We are open to collaboration but do not plan to give our data to others.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Edward Gerstenfeld, MD, University of California, San Francisco:
Atrial Fibrillation
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Oxymetazoline
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents