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

Status: Completed
Location: See location...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 19
Maximum Age: 80
Healthy Volunteers: t
View:

• Structural Heart Disease: Ischemic or Non-Ischemic Cardiomyopathy

• Sustained Monomorphic Ventricular Tachycardia documented by ECG or CIED interrogation

Locations
United States
Illinois
Henry Huang
Chicago
Time Frame
Start Date: 2018-01-01
Completion Date: 2023-01-31
Participants
Target number of participants: 103
Treatments
Surpoint Index Guided Ablation Group
Maximum Radiofrequency delivery duration cannot exceed Surpoint Index of 550
Conventional Ablation Group
Operator determined ablation duration regardless of Surpoint Index Value
Sponsors
Leads: Rush University Medical Center

This content was sourced from clinicaltrials.gov