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

Primary Purpose

Cardiac Catheter Ablation, Atrial Flutter, Cardiac Arrhythmias

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Data Collection During Atrial Flutter Ablation
Sponsored by
David B. De Lurgio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cardiac Catheter Ablation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Emory Saint Joseph's Hospital
  • Emory University Hospital Midtown

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Data Collection During Atrial Flutter Ablation

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Document the electrogram signatures that help demonstrate catheter tip contact

Full Information

First Posted
March 4, 2014
Last Updated
March 21, 2016
Sponsor
David B. De Lurgio
Collaborators
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02080975
Brief Title
Determination of Catheter Contact by Evaluation of Microelectrode Near-Field Signals
Acronym
IN-CONTACT
Official Title
Determination of Catheter Contact by Evaluation of Microelectrode Near-Field Signals
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
David B. De Lurgio
Collaborators
Boston Scientific Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Catheter Ablation, Atrial Flutter, Cardiac Arrhythmias

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Data Collection During Atrial Flutter Ablation
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Data Collection During Atrial Flutter Ablation
Intervention Description
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 Measure Information:
Title
Correlation between catheter contact and micro electrode signals
Description
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.
Time Frame
During Procedure
Secondary Outcome Measure Information:
Title
Document the electrogram signatures that help demonstrate catheter tip contact
Time Frame
During Procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David B De Lurgio, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory Saint Joseph's Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Emory University Hospital Midtown
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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