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

Completed · Not applicable

Conditions studied: Cardiac Catheter Ablation, Atrial Flutter, Cardiac Arrhythmias

In brief

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.

Key facts

Study ID

NCT02080975

Run by

David B. De Lurgio

People needed

20

Starts

2014-03-01

Expected to finish

2015-12-01

Last updated by the study team

2016-03-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Emory Saint Joseph's Hospital — Atlanta, Georgia, United States
• Emory University Hospital Midtown — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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