Surpoint Algorithm for Improved Guidance of Ablation for Ventricular Tachycardia

Completed

• Conditions: Ventricular Tachycardia
• Interventions: Device: Radiofrequency Ablation

• Registration Number: NCT05618717
• Lead Sponsor: Rush University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2022-11-09
• Primary Completion: 2022-11-11
• Study First Submitted QC: 2022-11-15
• Study First Posted: 2022-11-16
• Study Completion: 2023-01-31
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-03
• Last Update Posted: 2023-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Surpoint Index Guided Ablation Group	Radiofrequency Ablation	Maximum Radiofrequency delivery duration cannot exceed Surpoint Index of 550
Conventional Ablation Group	Radiofrequency Ablation	Operator determined ablation duration regardless of Surpoint Index Value

Primary Outcome Measures

Name	Time	Method
Recurrence Event of Sustained Ventricular Tachycardia or ICD therapy	2 years	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)

Secondary Outcome Measures

Name	Time	Method
Redo Ventricular Tachycardia Ablation Procedure	2 years	Outcome of repeat ablation procedure for sustained ventricular tachycardia or appropriate ICD therapy after index ventricular tachycardia ablation procedure
Hospitalization for Ventricular Tachycardia	2 yearr	Outcome of hospitalization for primary admission diagnosis of ventricular tachycardia with or without ICD treatment
All-Cause Mortality	2 years	Outcome of death after ablation procedure from cardiovascular or non-cardiovascular cause
Procedural Complications	7 days	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)

Trial Locations

Locations (1)

Henry Huang; 🇺🇸 Chicago, Illinois, United States