Surpoint Algorithm for Improved Guidance of Ablation for Ventricular Tachycardia (SURFIRE-VT)
Surpoint Algorithm for Improved Guidance of Ablation for Ventricular Tachycardia in Patients With Ischemic and Non-Ischemic Cardiomyopathy
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60657
- Henry Huang
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Surpoint Index Guided Ablation Group
Maximum Radiofrequency delivery duration cannot exceed Surpoint Index of 550
|
Radiofrequency Ablation using irrigated ablation catheter
|
|
Conventional Ablation Group
Operator determined ablation duration regardless of Surpoint Index Value
|
Radiofrequency Ablation using irrigated ablation catheter
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hospitalization for Ventricular Tachycardia
Time Frame: 2 yearr
|
Outcome of hospitalization for primary admission diagnosis of ventricular tachycardia with or without ICD treatment
|
2 yearr
|
|
All-Cause Mortality
Time Frame: 2 years
|
Outcome of death after ablation procedure from cardiovascular or non-cardiovascular cause
|
2 years
|
|
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
|
2 years
|
|
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)
|
7 days
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Casella M, Gasperetti A, Gianni C, Zucchelli G, Notarstefano P, Al-Ahmad A, Burkhardt JD, Soldati E, Della Rocca D, Catto V, Majocchi B, Carbucicchio C, Bongiorni MG, Dello Russo A, Natale A, Tondo C. Ablation Index as a predictor of long-term efficacy in premature ventricular complex ablation: A regional target value analysis. Heart Rhythm. 2019 Jun;16(6):888-895. doi: 10.1016/j.hrthm.2019.01.005. Epub 2019 Jan 4.
- Gasperetti A, Sicuso R, Dello Russo A, Zucchelli G, Saguner AM, Notarstefano P, Soldati E, Bongiorni MG, Della Rocca DG, Mohanty S, Carbucicchio C, Duru F, Di Biase L, Natale A, Tondo C, Casella M. Prospective use of ablation index for the ablation of right ventricle outflow tract premature ventricular contractions: a proof of concept study. Europace. 2021 Jan 27;23(1):91-98. doi: 10.1093/europace/euaa228.
- Sciacca V, Vogler J, Eitel C, Kuck KH, Tilz RR, Heeger CH. Ablation index-guided catheter ablation of incessant ventricular tachycardia originating from the anterolateral papillary muscle. Clin Res Cardiol. 2022 May;111(5):588-591. doi: 10.1007/s00392-021-01923-x. Epub 2021 Nov 1. No abstract available.
- Larsen T, Du-Fay-de-Lavallaz JM, Winterfield JR, Ravi V, Rhodes P, Wasserlauf J, Trohman RG, Sharma PS, Huang HD. Comparison of ablation index versus time-guided radiofrequency energy dosing using normal and half-normal saline irrigation in a porcine left ventricular model. J Cardiovasc Electrophysiol. 2022 Apr;33(4):698-712. doi: 10.1111/jce.15379. Epub 2022 Jan 30.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21011101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.