Determination of Catheter Contact by Evaluation of Microelectrode Near-Field Signals

Study Overview
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Brief Summary
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Successful radio frequency (RF) cardiac catheter ablation requires the creation of lesions by delivering energy while maintaining adequate catheter contact with the endocardium. Unfortunately, it is difficult to identify contact intraoperatively as a typical RF ablation catheter lacks clear indications of contact. We propose to use the Boston Scientific IntellaTip MiFi catheter to explore whether characteristics of the electrograms produced by the mini-electrodes on the ablation tip could help confirm tissue contact. Using an ultrasound catheter to define instances of clear contact and non-contact, we will determine whether the micro-electrodes produce sufficient information to confirm catheter contact. We propose that the MiFi catheter produces sufficient signal characteristics that can be used as an effective surrogate for adequate tissue contact.

Official Title
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Determination of Catheter Contact by Evaluation of Microelectrode Near-Field Signals

Conditions
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Cardiac Catheter Ablation, Atrial Flutter, Cardiac Arrhythmias

Intervention / Treatment
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* Other: Data Collection During Atrial Flutter Ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has a diagnosis of typical atrial flutter Subject is clinically indicated for right sided atrial flutter ablation Patient is willing and able to understand and sign the informed consent document Patient is over 18 years of age Patient is willing and able to comply with the study protocol Exclusion Criteria: Patient has one of the following cardiac comorbidities: hypertrophic cardiomyopathy, structural heart disease, congestive heart failure Patient has history of the following arrhythmias: ventricular tachycardia, ventricular fibrillation, Wolff-Parkinson-White syndrome Patient has a contraindication to right atrium ablation, including but not limited to: right atrial thrombus, active systemic infection, or a coagulopathy.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Data Collection During Atrial Flutter Ablation<br> | Other: Data Collection During Atrial Flutter Ablation<br>* All enrolled patients are clinically indicated for an atrial flutter ablation. The patients who consent for this study will have additional electrocardiograms taken during their procedure for future review, as well as ultrasound images form inside their heart. This will lengthen the ablation by approximately 10 minutes, but is not a separate procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between catheter contact and micro electrode signals | The known contact state of the ablation catheter will be compared in a blinded fashion to the signals from the microelectrodes to determine if a relationship exits. | During Procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Document the electrogram signatures that help demonstrate catheter tip contact |  | During Procedure |