EGM Analysis in Idiopathic Outflow Tract Ventricular Arrhythmia

Ventricular Outflow Tract Tachycardia Clinical Trial

Official title:

Usefulness of Unipolar and Bipolar Electrograms in Predicting Successful Ablation Site During Idiopathic Outflow Tract Ventricular Arrhythmia Ablation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02722577
• Other study ID #: SJM-CIP-10090
• Status: Completed
• Start date: March 2016
• Est. completion date: May 2017

Study information

• Verified date: July 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Investigate the value of unipolar and bipolar electrograms (EGM) for predicting the successful ablation site for idiopathic outflow tract ventricular arrhythmia (OTVA).

Description:

The proposed study aims to evaluate the predictive value of using reversed polarity in adjacent bipolar EGMs (bi-RP method) and unipolar EGM with QS morphology (uni-QS method) for identifying successful ablation site, and evaluate the feasibility of enhancing uni-QS method's performance by using its morphology characteristics such as descending slope and symmetry.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients scheduled to undergo ablation for idiopathic OTVA

• Have the ability to provide informed consent for study participation.

Exclusion Criteria:

• Be currently participating in any other investigational study

• Be less than 18 years of age

• Be pregnant

• Has any other conditions that are not suitable for catheter ablation (including but are not limited to active whole-body infection or sepsis, coagulation or hemorrhage disorder history)

Related Conditions & MeSH terms

• Tachycardia
• Ventricular Outflow Tract Tachycardia

Intervention

Procedure:
• Radio-frequency Ablation
A procedure that uses radiofrequency energy to destroy a small area of heart tissue that is causing rapid and irregular heartbeats.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of Ablation Targets With Termination of the Clinical Ventricular Arrhythmia After RF Energy Delivery		Intraoperative, an average of 2 hours