NCT02080975

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: David B. De Lurgio · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-03-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2014-03-07
• Last updated: 2016-03-22

Locations

2 sites across 1 country: United States