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

Atrial Fibrillation Clinical Trial

— Short-AF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04148664
• Other study ID #: SHORT-AF
• Status: Completed
• Phase: N/A
• Start date: December 3, 2019
• Est. completion date: December 30, 2022

Study information

• Verified date: August 2023
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 30, 2022
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Fibrillation Paroxysmal
• Atrial Fibrillation, Persistent

Intervention

Procedure:
• Catheter ablation with Standard RF ablation settings
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
High power short duration RF (n=30): Maximum 50 Watts for 5-15 seconds, per operator standard.

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

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