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RF Lesion Monitoring With 8mm IntellaTip MiFi XP

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02089672
Recruitment Status : Completed
First Posted : March 18, 2014
Last Update Posted : November 17, 2015
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by (Responsible Party):
Michael S. Lloyd, Emory University

Study Description
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Brief Summary:

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

Detailed Description:
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.
Study Design
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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Retrospective
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
Groups and Cohorts
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Group/Cohort Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Total bipolar electrogram amplitude using tip to ring and pin to pin configurations [ Time Frame: Acute, averaged one hour during ablation. Measured postoperatively. ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Enrollment will include 25 patients undergoing a radiofrequency ablation procedure in which ablation of the cavotricuspid isthmus is planned.
Criteria

Inclusion Criteria:

  • Any adult undergoing an atrial flutter ablation

Exclusion Criteria:

-

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02089672


Locations
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United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Boston Scientific Corporation
Investigators
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Principal Investigator: Michael Lloyd, MD FHRS FACC Emory University
More Information
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Additional Information:

Publications:

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Responsible Party: Michael S. Lloyd, Principal investigator, Emory University
ClinicalTrials.gov Identifier: NCT02089672    
Other Study ID Numbers: IRB00069674
ISRCRM90003 ( Other Identifier: Other )
First Posted: March 18, 2014    Key Record Dates
Last Update Posted: November 17, 2015
Last Verified: November 2015
Additional relevant MeSH terms:
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Atrial Flutter
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes