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NCT Number: NCT05618717

Surpoint Algorithm for Improved Guidance of Ablation for Ventricular Tachycardia

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.

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Key information

Conditions

Ventricular Tachycardia Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia Tachycardia, Ventricular

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Henry Huang

Chicago, Illinois, 60657, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiofrequency Ablation

Device

Radiofrequency Ablation using irrigated ablation catheter

Primary outcomes

  1. Recurrence Event of Sustained Ventricular Tachycardia or ICD therapy

    Time frame: 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 outcomes

  1. Hospitalization for Ventricular Tachycardia

    Time frame: 2 yearr

    Outcome of hospitalization for primary admission diagnosis of ventricular tachycardia with or without ICD treatment

  2. All-Cause Mortality

    Time frame: 2 years

    Outcome of death after ablation procedure from cardiovascular or non-cardiovascular cause

  3. Redo Ventricular Tachycardia Ablation Procedure

    Time frame: 2 years

    Outcome of repeat ablation procedure for sustained ventricular tachycardia or appropriate ICD therapy after index ventricular tachycardia ablation procedure

  4. Procedural Complications

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Registry information

Official study title

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

Acronym: SURFIRE-VT

Important dates

Study start
2018
Primary completion
2022
Study completion
2023
First posted
Nov 16, 2022
Registry last updated
Dec 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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