Surpoint Algorithm for Improved Guidance of Ablation for Ventricular Tachycardia
NCT ID: NCT05618717
Last Updated: 2023-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
103 participants
OBSERVATIONAL
2018-01-01
2023-01-31
Brief Summary
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In this single center prospective observation registry, a ventricular ablation strategy utilizing radiofrequency delivery duration cut off determined by a maximum Surpoint index value of 550 will be compared to conventional operator determined duration of radiofrequency delivery based on combination of time (i.e. 30, 60, 90, and 120 seconds), magnitude of impedance drop, attenuation of abnormal electrograms, and achieving non-capture with high-output pacing after ablation.
The Surpoint Tag Index Ablation group will be matched with a control group of patients undergoing VT ablation using the conventional time-based radiofrequency strategy and the patients in this group will be selected using propensity matching based on relevant baseline patient and clinical characteristic variables.
Primary outcomes of interest: Recurrence of sustained ventricular tachycardia or Internal Cardiac Defibrillator Therapy.
Secondary outcomes of interest: Hospitalization for ventricular tachycardia, repeat ablation procedures, all-cause mortality, acute procedural complications, rate of steam pops during ablation procedures
Follow up: Up to 24 months after ablation procedure. Follow up will be obtained by office visits and device interrogation reports.
Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Surpoint Index Guided Ablation Group
Maximum Radiofrequency delivery duration cannot exceed Surpoint Index of 550
Radiofrequency Ablation
Radiofrequency Ablation using irrigated ablation catheter
Conventional Ablation Group
Operator determined ablation duration regardless of Surpoint Index Value
Radiofrequency Ablation
Radiofrequency Ablation using irrigated ablation catheter
Interventions
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Radiofrequency Ablation
Radiofrequency Ablation using irrigated ablation catheter
Eligibility Criteria
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Inclusion Criteria
* Sustained Monomorphic Ventricular Tachycardia documented by ECG or CIED interrogation
Exclusion Criteria
* Myocardial infarction or Cardiac Surgery within 6 months
* Severe mitral regurgitation
* Stroke or TIA within 6 months
* Prior Ventricular Tachycardia Ablation
19 Years
80 Years
ALL
Yes
Sponsors
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Rush University Medical Center
OTHER
Responsible Party
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Henry Huang
Primary Investigator
Locations
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Henry Huang
Chicago, Illinois, United States
Countries
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References
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Casella M, Gasperetti A, Gianni C, Zucchelli G, Notarstefano P, Al-Ahmad A, Burkhardt JD, Soldati E, Della Rocca D, Catto V, Majocchi B, Carbucicchio C, Bongiorni MG, Dello Russo A, Natale A, Tondo C. Ablation Index as a predictor of long-term efficacy in premature ventricular complex ablation: A regional target value analysis. Heart Rhythm. 2019 Jun;16(6):888-895. doi: 10.1016/j.hrthm.2019.01.005. Epub 2019 Jan 4.
Gasperetti A, Sicuso R, Dello Russo A, Zucchelli G, Saguner AM, Notarstefano P, Soldati E, Bongiorni MG, Della Rocca DG, Mohanty S, Carbucicchio C, Duru F, Di Biase L, Natale A, Tondo C, Casella M. Prospective use of ablation index for the ablation of right ventricle outflow tract premature ventricular contractions: a proof of concept study. Europace. 2021 Jan 27;23(1):91-98. doi: 10.1093/europace/euaa228.
Sciacca V, Vogler J, Eitel C, Kuck KH, Tilz RR, Heeger CH. Ablation index-guided catheter ablation of incessant ventricular tachycardia originating from the anterolateral papillary muscle. Clin Res Cardiol. 2022 May;111(5):588-591. doi: 10.1007/s00392-021-01923-x. Epub 2021 Nov 1. No abstract available.
Larsen T, Du-Fay-de-Lavallaz JM, Winterfield JR, Ravi V, Rhodes P, Wasserlauf J, Trohman RG, Sharma PS, Huang HD. Comparison of ablation index versus time-guided radiofrequency energy dosing using normal and half-normal saline irrigation in a porcine left ventricular model. J Cardiovasc Electrophysiol. 2022 Apr;33(4):698-712. doi: 10.1111/jce.15379. Epub 2022 Jan 30.
Other Identifiers
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21011101
Identifier Type: -
Identifier Source: org_study_id