Parallel Mapping for Ventricular Tachycardia

NCT04477499 | Completed

• 1 other identifier: IRB 20-470
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventricular Tachycardia (V-Tach); Implantable Cardioverter Defibrillator (ICD); Arrythmia

Outcome Measures

Primary Outcomes (1)

• Single procedure freedom from ventricular recurrence at 1 year

  Number of VT

  12 months

Secondary Outcomes (3)

• Freedom from implantable cardioverter defibrillator (ICD) shocks

  12 months

• Reduction in mapping time using parallel mapping algorithm

  12 months

• Reduction in radiofrequency ablation time

  12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Biosense Webster, Inc.: collaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Tachycardia, Ventricular; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

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

Study Officials

• Jakub Sroubek, MD, PhD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 15, 2020
• First Posted: July 20, 2020
• Study Start: July 15, 2020
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: January 10, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)