RF Lesion Monitoring With 8mm IntellaTip MiFi XP
|ClinicalTrials.gov Identifier: NCT02089672|
Recruitment Status : Completed
First Posted : March 18, 2014
Last Update Posted : November 17, 2015
Abnormal heart rhythms or arrhythmias are often managed by a procedure in which a catheter is introduced into the heart. These catheters can then cauterize abnormally functioning portions of the heart muscle with the hope of returning the heart to a more effective rhythm. In the process of performing such a procedure, called a catheter ablation, an operator must be able to accurately sense electrical activity displayed on computer screens in different parts of the heart, provide sufficient localized energy to the abnormally behaving tissue (ideally without damaging uninvolved heart structures), and accurately reassess the electrical activity of the heart to ensure the spot in the heart has been cauterized.
When sensing electrical activity of the heart, specialized catheters produce recordings on a computer screen known as electrograms (EGM). To produce this recording conventional catheters commonly use a positive and negative electrode, from which the difference between the two provides the EGM. The distance between the two electrodes varies from device to device. The greater the distance between them, the less accurate the measurement of local electrical activity becomes. This may result in poorly localized or excessive use of energy that could be damaging to normal heart structures or put the patient at risk for the return or development of additional arrhythmias. The IntellaTip MiFi catheter has been constructed with a specialized sensing tip that uses "microelectrodes" that are relatively close in proximity (<1 mm apart) with the hope of improving the sensing capability of the device.
This study will analyze the signals obtained from this FDA-approved catheter in people undergoing a catheter ablation procedure. The study will examine signals after the procedure is finished and will not prolong or differ the process from a standard ablation procedure. The goal of this study is to determine the ability of the microelectrodes to distinguish ablated, or cauterized versus non-cauterized tissue.
|Condition or disease||Intervention/treatment|
|Atrial Flutter Arrhythmia||Device: Catheter ablation|
|Study Type :||Observational|
|Actual Enrollment :||30 participants|
|Official Title:||Radiofrequency Ablation Lesion Monitoring Using Imbedded Micro-Electrodes Versus Standard Bipolar Electrograms|
|Study Start Date :||April 2014|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||November 2015|
Atrial flutter patients
Atrial flutter patients undergoing catheter ablation
Device: Catheter ablation
This is observational trial studying the effects of a standard intervention of a catheter ablation procedure.
Other Name: 8mm IntellaTip MiFi XP ablation catheter
- Total bipolar electrogram amplitude using tip to ring and pin to pin configurations [ Time Frame: Acute, averaged one hour during ablation. Measured postoperatively. ]
- Total number of seconds per isthmus ablation spent in excess of the post-hoc identified complete lesion time. [ Time Frame: Acute, averaged one hour during ablation. Measured postoperatively ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02089672
|United States, Georgia|
|Emory University Hospital|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Michael Lloyd, MD FHRS FACC||Emory University|