Determination of Catheter Contact by Evaluation of Microelectrode Near-Field Signals (IN-CONTACT)

David B. De Lurgio

Status

Completed

Conditions

Atrial Flutter

Cardiac Catheter Ablation

Cardiac Arrhythmias

Treatments

Other: Data Collection During Atrial Flutter Ablation

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02080975

IRB00071344

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.