Clinical trial NCT04477499: Parallel Mapping for Ventricular Tachycardia
Official title: Ablation of Ventricular Tachycardia Guided by Multi-site Pacing Using Parallel Mapping
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventricular Tachycardia (V-Tach)
Implantable Cardioverter Defibrillator (ICD)
Arrythmia
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: Biosense Webster, Inc.
First posted: 2020-07-20
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Single procedure freedom from ventricular recurrence at 1 year
timeFrame: 12 months
Secondary outcomes:
measure: Freedom from implantable cardioverter defibrillator (ICD) shocks
timeFrame: 12 months
measure: Reduction in mapping time using parallel mapping algorithm
timeFrame: 12 months
measure: Reduction in radiofrequency ablation time
timeFrame: 12 months
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Jakub Sroubek, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: