Parallel Mapping for Ventricular Tachycardia

Ablation of Ventricular Tachycardia Guided by Multi-site Pacing Using Parallel Mapping

Catheter ablation in patients with ventricular tachycardia using a new mapping algorithm called, parallel mapping, that is aimed to increase the specificity of mapping and the outcome of ablation.

Study Overview

• Status: Completed
• Conditions: Arrythmia; Implantable Cardioverter Defibrillator (ICD); Ventricular Tachycardia (V-Tach)

Detailed Description

In patients with scar in the hearts after heart attacks, the risk for dangerous abnormal heart rhythms, including sudden death is high. This is because dead muscle fibers are replaced by scar tissue, creating a physiological condition promoting abnormal heart rhythms.These abnormal heart rhythms are called ventricular arrhythmias or ventricular tachycardias. In these patients, ablation procedures can be helpful, however the recurrence rate of arrhythmias after ablation remains unacceptably high. The primary reason for this high recurrence rate is nonspecific mapping methodologies for identifying the heart area responsible for these arrhythmias. Therefore, new methods for increasing the specificity of mapping have been the subject of significant research for many years, however implementation of these methods in clinical practice has been challenged by limited technologies. Recently, a new mapping technology named "parallel mapping" has been developed, received FDA approval and is routinely utilized at the Cleveland Clinic. However, the workflow of using parallel mapping, and the efficacy of ablation using this technology have not been evaluated.

• Study Type: Observational
• Enrollment (Actual): 44

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with history of scar-mediated recurrent ventricular tachycardia, who had failed therapy with anti arrhythmic drugs. All patients are planned to undergo catheter ablation procedure for ventricular tachycardia as part of the usual clinical care. All patients who meet the eligibility criteria may be included in the study regardless of gender, race or ethnicity.

Description

Inclusion Criteria:

• Age ≥18 years
• History of scar-mediated sustained ventricular tachycardia
• Failure of therapy with Anti arrhythmic drugs
• Implanted ICD or a plan for ICD implantation after the ablation
• Willingness to adhere to the study restrictions and comply with all post procedural follow-up requirements
• Ability to understand the requirements of the study and sign an informed consent

Exclusion Criteria:

• Patients with reversible causes of ventricular tachycardia including ongoing ischemia or electrolyte abnormalities
• Contraindication to anticoagulation therapy
• Stroke within 30 days before enrollment
• Life expectancy <1 year
• Individual has a known, unresolved history of drug use or alcohol dependency lacks the ability to comprehend or follow instructions or would be unlikely or unable to comply with study follow-up requirements
• Pregnant or breast feeding at time of signing consent
• Patient undergoing cardiac transplantation
• Enrolled or participates in other drug or device studies

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Single procedure freedom from ventricular recurrence at 1 year	Number of VT	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from implantable cardioverter defibrillator (ICD) shocks	Number of ICD shocks	12 months
Reduction in mapping time using parallel mapping algorithm	Minutes	12 months
Reduction in radiofrequency ablation time	Minutes	12 months

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Collaborators: Biosense Webster, Inc.
• Investigators: Principal Investigator: Jakub Sroubek, MD, PhD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2020
• Primary Completion (Actual): December 30, 2022
• Study Completion (Actual): December 30, 2022

Study Registration Dates

• First Submitted: July 15, 2020
• First Submitted That Met QC Criteria: July 15, 2020
• First Posted (Actual): July 20, 2020

Study Record Updates

• Last Update Posted (Estimate): January 10, 2023
• Last Update Submitted That Met QC Criteria: January 9, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Tachycardia; Tachycardia, Ventricular
• Other Study ID Numbers: IRB 20-470

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No