Ventricular Arrhythmia Ablation With the Use of Non-Invasive ECG Imaging Technology

NCT04219501 | Withdrawn

• 1 other identifier: 19-007683
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Researchers are trying to determine if the use of software called VIVO, made by Catheter Precision, Inc. can shorten the length of time it takes to perform an ablation procedure for either premature ventricular contractions (PVCs) and ventricular tachycardia (VT).

Conditions

Premature Ventricular Contraction; Ventricular Tachycardia

Outcome Measures

Primary Outcomes (2)

• Standard of care invasive electroanatomical mapping system duration

  Total amount of time for standard of care invasive mapping measured in minutes

  Baseline

• VIVO non-invasive mapping system duration

  Total amount of time for non-invasive mapping using VIVO measured in minutes

  Baseline

Study Arms (2)

Control Group

NO INTERVENTION

Subjects presenting for PVC/VT ablation will undergo ablation procedures using standard of care invasive electroanatomical mapping systems.

VIVO Arm

EXPERIMENTAL

Subjects presenting for PVC/VT ablation, that have a previously acquired cardiac CT/MRI scan or are having a cardiac CT/MRI scan as per routine care, will undergo ablation procedures using VIVO, a novel, non-invasive mapping system.

Other: VIVO

Interventions

VIVO OTHER

Non-invasive mapping system software product that combines patient-specific images (MRI or CT) of the torso and cardiac structures and a 3D image of the torso that identifies precise ECG lead placement to generate a 3D model of the patient's heart.

VIVO Arm

Eligibility Criteria

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

You may qualify if:

• At least 18 years of age
• Structurally normal heart
• Cardiac MRI/CT as part of standard of care
• Diagnosed with premature ventricular contractions or ventricular tachycardia and scheduled to undergo an ablation to treat these conditions

You may not qualify if:

• Less than 18 years of age
• Structurally abnormal heart

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Ventricular Premature Complexes; Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

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

Study Officials

• Fred Kusumoto, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 3, 2020
• First Posted: January 7, 2020
• Study Start: February 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 8, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)