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

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.

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Key information

Conditions

Cardiac Catheter Ablation Arrhythmias, Cardiac Atrial Flutter Cardiac Arrhythmias Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emory Saint Joseph's Hospital, Atlanta, Georgia, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Data Collection During Atrial Flutter Ablation

Other

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.

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

Time frame: During Procedure

Sponsors and collaborators

Lead sponsor

David B. De Lurgio

Other

Collaborators

Boston Scientific Corporation

Registry information

Acronym: IN-CONTACT

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Mar 7, 2014
Registry last updated: Mar 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed