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NCT02089672 · ClinicalTrials.gov registry record
RF Lesion Monitoring With 8mm IntellaTip MiFi XP
A clinical trial, sponsored by Emory University.
- Completed
- Registry status
- 30
- Enrollment target
NCT02089672: Completed study, sponsored by Emory University.
NCT02089672 is a clinical trial that has completed, run by Emory University. The registered enrollment target is 30 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02089672 has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- 30 participants
- Enrollment target
Study 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 cauterize
Interventions
- DEVICE Catheter ablation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2014-04 |
| Est. Completion | 2015-11 |
What the finished NCT02089672 record still lists
NCT02089672 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 30 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Catheter ablation is the first listed.
NCT02089672 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02089672 about?
NCT02089672 is a clinical study titled "RF Lesion Monitoring With 8mm IntellaTip MiFi XP". 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 performin...
What is the current status of trial NCT02089672?
This trial is currently completed. The enrollment target is 30 participants. The study started on 2014-04. Estimated completion is 2015-11.
What interventions are being tested in trial NCT02089672?
The interventions under investigation include: Catheter ablation (DEVICE).
Who is sponsoring clinical trial NCT02089672?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
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