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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02080975
Other study ID # IRB00071344
Secondary ID
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


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
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