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Data Collection During Atrial Flutter Ablation for Atrial Flutter (IN-CONTACT Trial)

N/A
Waitlist Available
Led By David B De Lurgio, MD
Research Sponsored by David B. De Lurgio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during procedure
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Atrial Flutter
  • Cardiac Catheter Ablation
  • Arrhythmia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and during procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Correlation between catheter contact and micro electrode signals

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Data Collection During Atrial Flutter AblationExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Boston Scientific CorporationIndustry Sponsor
744 Previous Clinical Trials
857,783 Total Patients Enrolled
10 Trials studying Atrial Flutter
1,426 Patients Enrolled for Atrial Flutter
David B. De LurgioLead Sponsor
1 Previous Clinical Trials
3 Total Patients Enrolled
David B De Lurgio, MDPrincipal InvestigatorEmory University
~2 spots leftby Nov 2025