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

NCT02080975 | Completed DMC

• 1 other identifier: IRB00071344
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Cardiac Catheter Ablation; Atrial Flutter; Cardiac Arrhythmias

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Document the electrogram signatures that help demonstrate catheter tip contact

  During Procedure

Study Arms (1)

Data Collection During Atrial Flutter Ablation

EXPERIMENTAL

Other: Data Collection During Atrial Flutter Ablation

Interventions

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.

Data Collection During Atrial Flutter Ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• David B. De Lurgio: lead
• Boston Scientific Corporation: collaborator

Study Sites (2)

Emory Saint Joseph's Hospital

Atlanta, Georgia, 30308, United States

Location

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

MeSH Terms

Conditions

Atrial Flutter; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• David B De Lurgio, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 4, 2014
• First Posted: March 7, 2014
• Study Start: March 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 22, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)