Radiofrequency Ablation Lesion Monitoring Using Imbedded Micro-Electrodes Versus Standard Bipolar Electrograms
Data Collection
Collected from past medical records and data - RetrospectiveArrhythmias, Cardiac+3
+ Atrial Flutter
+ Cardiovascular Diseases
Case-Only
Examining characteristics of individuals with a disease in order to identify genetic or environmental factors contributing to the condition.Summary
Study start date: April 1, 2014
Actual date on which the first participant was enrolled.This trial is an operator-blinded, acute, single-visit observational trial in humans. Enrollment will include 25 patients undergoing a radiofrequency ablation procedure in which ablation of the cavotricuspid isthmus is planned. Electrogram characteristics of the small, imbedded pin electrodes will be compared to standard bipolar EGMs utilizing the ablation tip electrode and ring. Absolute voltage, voltage reduction, and frequency spectra will be examined before, during, and after ablation. EGM characteristics of standard and "ultra-local" recordings will be compared in their ability to accurately identify an effective RF lesion as defined below.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.30 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Case-only
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Any adult undergoing an atrial flutter ablation Exclusion Criteria: \-
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location