Clinical trial NCT05618717: Surpoint Algorithm for Improved Guidance of Ablation for Ventricular Tachycardia
Official title: Surpoint Algorithm for Improved Guidance of Ablation for Ventricular Tachycardia in Patients With Ischemic and Non-Ischemic Cardiomyopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventricular Tachycardia
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2022-11-16
Enrollment: 103
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: History of Ischemic or non-ischemic cardiomyopathy with sustained ventricular tachycardia

Brief summary: Vistag SurPoint is a proprietary module that generates a numerical tag index which can be used as multiparametric lesion quality marker to guide ablation in the clinical setting for ablation of atrial arrhythmias. SurPoint tag index has studied to guide ablation of ventricular arrhythmias, such as premature ventricular complexes, but its effectiveness and safety for ablation of Ventricular Tachycardia in patient with Ischemic and Non-Ischemic Cardiomyopathies is not well established.

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.


Eligibility criteria: Inclusion Criteria:

* Structural Heart Disease: Ischemic or Non-Ischemic Cardiomyopathy
* Sustained Monomorphic Ventricular Tachycardia documented by ECG or CIED interrogation

Exclusion Criteria:

* If clinical ventricular arrhythmia is predominantly PVCs, polymorphic ventricular tachycardia, or ventricular fibrillation
* Myocardial infarction or Cardiac Surgery within 6 months
* Severe mitral regurgitation
* Stroke or TIA within 6 months
* Prior Ventricular Tachycardia Ablation

Primary outcomes:
measure: Recurrence Event of Sustained Ventricular Tachycardia or ICD therapy
timeFrame: 2 years
Secondary outcomes:
measure: Hospitalization for Ventricular Tachycardia
timeFrame: 2 yearr
measure: All-Cause Mortality
timeFrame: 2 years
measure: Redo Ventricular Tachycardia Ablation Procedure
timeFrame: 2 years
measure: Procedural Complications
timeFrame: 7 days
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Henry Huang
state: Illinois
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.