Surpoint Algorithm for Improved Guidance of Ablation for Ventricular Tachycardia

NCT05618717 | Completed FDA Device

• 1 other identifier: 21011101
• Study Type: observational
• Target: 103
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventricular Tachycardia

Outcome Measures

Primary Outcomes (1)

• Recurrence Event of Sustained Ventricular Tachycardia or ICD therapy

  Composite outcome of sustained ventricular tachycardia (episode lasting \> 30 seconds detected by ICD) or ventricular tachycardia episode treated successfully by ICD therapy (Including ventricular tachycardia episodes terminated by ATP or ICD shock in \< 30 seconds based programmed detection/treatment ICD settings)

  2 years

Secondary Outcomes (4)

• Hospitalization for Ventricular Tachycardia

  2 yearr

• All-Cause Mortality

  2 years

• Redo Ventricular Tachycardia Ablation Procedure

  2 years

• Procedural Complications

  7 days

Study Arms (2)

Surpoint Index Guided Ablation Group

Maximum Radiofrequency delivery duration cannot exceed Surpoint Index of 550

Device: Radiofrequency Ablation

Conventional Ablation Group

Operator determined ablation duration regardless of Surpoint Index Value

Device: Radiofrequency Ablation

Interventions

Radiofrequency Ablation DEVICE

Radiofrequency Ablation using irrigated ablation catheter

Conventional Ablation Group; Surpoint Index Guided Ablation Group

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

History of Ischemic or non-ischemic cardiomyopathy with sustained ventricular tachycardia

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Henry Huang

Chicago, Illinois, 60657, United States

Location

Related Publications (4)

• 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.

  PMID: 30616020 BACKGROUND

• 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.

  PMID: 33063099 BACKGROUND

• 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.

  PMID: 34724088 BACKGROUND

• 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.

  PMID: 35048448 BACKGROUND

MeSH Terms

Conditions

Tachycardia, Ventricular

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: November 9, 2022
• First Posted: November 16, 2022
• Study Start: January 1, 2018
• Primary Completion: November 11, 2022
• Study Completion: January 31, 2023
• Last Updated: December 5, 2023

Record last verified: 2023-12

Locations

US (1)