Determination of Catheter Contact by Evaluation of Microelectrode Near-Field Signals
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiac Catheter Ablation
- Sponsor
- David B. De Lurgio
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Correlation between catheter contact and micro electrode signals
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
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.
Investigators
David B. De Lurgio
Associate Professor
Emory University
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Correlation between catheter contact and micro electrode signals
Time Frame: During Procedure
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.
Secondary Outcomes
- Document the electrogram signatures that help demonstrate catheter tip contact(During Procedure)