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

NCT04148664 | Completed DMC

• 1 other identifier: SHORT-AF
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Atrial Fibrillation Paroxysmal; Atrial Fibrillation, Persistent

Keywords

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Ablation Duration

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

  During Ablation

Secondary Outcomes (14)

• Maximum esophageal temperature

  During ablation

• Maximum esophageal temperature rise

  During ablation

• Freedom from Atrial Fibrillation

  assessed at 6 and 12 months post-ablation

• Freedom from Atrial Fibrillation

  assessed at 6 and 12 months post-ablation

• % pulmonary vein pairs isolated with first encirclement

  During Ablation

Study Arms (2)

Standard Catheter Settings

ACTIVE COMPARATOR

Group 1 - Standard RF ablation settings

Procedure: Catheter ablation with Standard RF ablation settings

High Power Short Duration (HPSD)

EXPERIMENTAL

Group 2 - High power short duration RF

Procedure: Catheter ablation with High Power Short Duration RF ablation settings

Interventions

Catheter ablation with Standard RF ablation settings PROCEDURE

Standard RF ablation settings (n=30): Maximum 35W for 20-40 seconds, per operator standard.

Standard Catheter Settings

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.

High Power Short Duration (HPSD)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (10)

• Perino AC, Leef GC, Cluckey A, Yunus FN, Askari M, Heidenreich PA, Narayan SM, Wang PJ, Turakhia MP. Secular trends in success rate of catheter ablation for atrial fibrillation: The SMASH-AF cohort. Am Heart J. 2019 Feb;208:110-119. doi: 10.1016/j.ahj.2018.10.006. Epub 2018 Oct 29.

  PMID: 30502925 BACKGROUND

• Kim TH, Park J, Uhm JS, Joung B, Lee MH, Pak HN. Pulmonary vein reconnection predicts good clinical outcome after second catheter ablation for atrial fibrillation. Europace. 2017 Jun 1;19(6):961-967. doi: 10.1093/europace/euw128.

  PMID: 27256420 BACKGROUND

• Asbach S, Biermann J, Bode C, Faber TS. Early Heparin Administration Reduces Risk for Left Atrial Thrombus Formation during Atrial Fibrillation Ablation Procedures. Cardiol Res Pract. 2011;2011:615087. doi: 10.4061/2011/615087. Epub 2011 Jul 2.

  PMID: 21747989 BACKGROUND

• Winkle RA, Mohanty S, Patrawala RA, Mead RH, Kong MH, Engel G, Salcedo J, Trivedi CG, Gianni C, Jais P, Natale A, Day JD. Low complication rates using high power (45-50 W) for short duration for atrial fibrillation ablations. Heart Rhythm. 2019 Feb;16(2):165-169. doi: 10.1016/j.hrthm.2018.11.031.

  PMID: 30712645 BACKGROUND

• Leshem E, Zilberman I, Tschabrunn CM, Barkagan M, Contreras-Valdes FM, Govari A, Anter E. High-Power and Short-Duration Ablation for Pulmonary Vein Isolation: Biophysical Characterization. JACC Clin Electrophysiol. 2018 Apr;4(4):467-479. doi: 10.1016/j.jacep.2017.11.018. Epub 2018 Feb 2.

  PMID: 30067486 BACKGROUND

• Nair KK, Shurrab M, Skanes A, Danon A, Birnie D, Morillo C, Chauhan V, Mangat I, Ayala-Paredes F, Champagne J, Nault I, Tang A, Verma A, Lashevsky I, Singh SM, Crystal E. The prevalence and risk factors for atrioesophageal fistula after percutaneous radiofrequency catheter ablation for atrial fibrillation: the Canadian experience. J Interv Card Electrophysiol. 2014 Mar;39(2):139-44. doi: 10.1007/s10840-013-9853-z. Epub 2013 Dec 7.

  PMID: 24317916 BACKGROUND

• Nair KK, Danon A, Valaparambil A, Koruth JS, Singh SM. Atrioesophageal Fistula: A Review. J Atr Fibrillation. 2015 Oct 31;8(3):1331. doi: 10.4022/jafib.1331. eCollection 2015 Oct-Nov.

  PMID: 27957213 BACKGROUND

• Han HC, Ha FJ, Sanders P, Spencer R, Teh AW, O'Donnell D, Farouque O, Lim HS. Atrioesophageal Fistula: Clinical Presentation, Procedural Characteristics, Diagnostic Investigations, and Treatment Outcomes. Circ Arrhythm Electrophysiol. 2017 Nov;10(11):e005579. doi: 10.1161/CIRCEP.117.005579.

  PMID: 29109075 BACKGROUND

• Bhaskaran A, Chik W, Pouliopoulos J, Nalliah C, Qian P, Barry T, Nadri F, Samanta R, Tran Y, Thomas S, Kovoor P, Thiagalingam A. Five seconds of 50-60 W radio frequency atrial ablations were transmural and safe: an in vitro mechanistic assessment and force-controlled in vivo validation. Europace. 2017 May 1;19(5):874-880. doi: 10.1093/europace/euw077.

  PMID: 27207815 BACKGROUND

• Baher A, Kheirkhahan M, Rechenmacher SJ, Marashly Q, Kholmovski EG, Siebermair J, Acharya M, Aljuaid M, Morris AK, Kaur G, Han FT, Wilson BD, Steinberg BA, Marrouche NF, Chelu MG. High-Power Radiofrequency Catheter Ablation of Atrial Fibrillation: Using Late Gadolinium Enhancement Magnetic Resonance Imaging as a Novel Index of Esophageal Injury. JACC Clin Electrophysiol. 2018 Dec;4(12):1583-1594. doi: 10.1016/j.jacep.2018.07.017. Epub 2018 Sep 26.

  PMID: 30573123 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Edward P Gerstenfeld, MD

  Chief of Cardiac Electrophysiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 30, 2019
• First Posted: November 1, 2019
• Study Start: December 3, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 30, 2022
• Last Updated: August 16, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)