Surpoint Algorithm for Improved Guidance of Ablation for Ventricular Tachycardia (SURFIRE-VT)

Rush

Status: Completed

Conditions: Ventricular Tachycardia

Treatments: Device: Radiofrequency Ablation

Study type: Observational

Funder types: Other

Identifiers

NCT05618717

21011101

Details and patient eligibility

About

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.

Enrollment: 103 patients

Sex: All

Ages: 19 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

103 participants in 2 patient groups

Surpoint Index Guided Ablation Group

Description:

Maximum Radiofrequency delivery duration cannot exceed Surpoint Index of 550

Treatment:

Device: Radiofrequency Ablation

Conventional Ablation Group

Description:

Operator determined ablation duration regardless of Surpoint Index Value

Treatment:

Device: Radiofrequency Ablation