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

Atrial Flutter Clinical Trial

— IN-CONTACT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02080975
• Other study ID #: IRB00071344
• Status: Completed
• Phase: N/A
• First received: March 4, 2014
• Last updated: March 21, 2016
• Start date: March 2014
• Est. completion date: December 2015

Study information

• Verified date: March 2016
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Atrial Flutter
• Cardiac Arrhythmias
• Cardiac Catheter Ablation

Intervention

Other:
• Data Collection During Atrial Flutter Ablation
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.

Locations

Country	Name	City	State
United States	Emory Saint Joseph's Hospital	Atlanta	Georgia
United States	Emory University Hospital Midtown	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
David B. De Lurgio	Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Document the electrogram signatures that help demonstrate catheter tip contact		During Procedure	No