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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02080975
Recruitment Status : Completed
First Posted : March 7, 2014
Last Update Posted : March 22, 2016
Boston Scientific Corporation
Information provided by (Responsible Party):
David B. De Lurgio, Emory University

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.

Condition or disease Intervention/treatment Phase
Cardiac Catheter Ablation Atrial Flutter Cardiac Arrhythmias Other: Data Collection During Atrial Flutter Ablation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Determination of Catheter Contact by Evaluation of Microelectrode Near-Field Signals
Study Start Date : March 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Arm Intervention/treatment
Experimental: Data Collection During Atrial Flutter Ablation 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.

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Document the electrogram signatures that help demonstrate catheter tip contact [ Time Frame: During Procedure ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02080975

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United States, Georgia
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States, 30308
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
Sponsors and Collaborators
David B. De Lurgio
Boston Scientific Corporation
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Principal Investigator: David B De Lurgio, MD Emory University

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Responsible Party: David B. De Lurgio, Associate Professor, Emory University Identifier: NCT02080975    
Other Study ID Numbers: IRB00071344
First Posted: March 7, 2014    Key Record Dates
Last Update Posted: March 22, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Atrial Flutter
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes