Surpoint Algorithm for Improved Guidance of Ablation for Ventricular Tachycardia

Ventricular Tachycardia Clinical Trial

— SURFIRE-VT  

Official title:

Surpoint Algorithm for Improved Guidance of Ablation for Ventricular Tachycardia in Patients With Ischemic and Non-Ischemic Cardiomyopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05618717
• Other study ID #: 21011101
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: January 31, 2023

Study information

• Verified date: December 2023
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: January 31, 2023
• Est. primary completion date: November 11, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Tachycardia
• Tachycardia, Ventricular
• Ventricular Tachycardia

Intervention

Device:
• Radiofrequency Ablation
Radiofrequency Ablation using irrigated ablation catheter

Locations

Country	Name	City	State
United States	Henry Huang	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Rush University Medical Center

Country where clinical trial is conducted

United States, 

References & 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Hospitalization for Ventricular Tachycardia	Outcome of hospitalization for primary admission diagnosis of ventricular tachycardia with or without ICD treatment	2 yearr
Secondary	All-Cause Mortality	Outcome of death after ablation procedure from cardiovascular or non-cardiovascular cause	2 years
Secondary	Redo Ventricular Tachycardia Ablation Procedure	Outcome of repeat ablation procedure for sustained ventricular tachycardia or appropriate ICD therapy after index ventricular tachycardia ablation procedure	2 years
Secondary	Procedural Complications	Outcome of rate of complications with 7 days of ventricular tachycardia ablation procedure including but not limited to bleeding, death, pericardial effusion, cardiac tamponade, stroke, arterial thromboemblism, steam pops, thrombus formation, cardiogenic shock, phrenic nerve paralysis, congestive heart failure)	7 days