NCT05618717

Surpoint Algorithm for Improved Guidance of Ablation for Ventricular Tachycardia

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 103 (actual)
• Sponsor: Rush University Medical Center · Academic / Other
• Sex: All
• Age: 19 Years – 80 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DEVICE	Radiofrequency Ablation	Radiofrequency Ablation using irrigated ablation catheter

Timeline

• Start date: 2018-01-01
• Primary completion: 2022-11-11
• Completion: 2023-01-31
• First posted: 2022-11-16
• Last updated: 2023-12-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study