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Clinical Trials/ACTRN12613000317796
ACTRN12613000317796
Recruiting
Phase 1

Feasibility Study to assess the performance of IntellaTip MiFi™ XP Temperature Ablation Catheter System for the treatment of Subjects with Sustained or Recurrent Type I Atrial Flutter

Boston Scientific Corporation0 sites20 target enrollmentMarch 21, 2013
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ConditionsAtrial Flutter ArrhythmiaCardiovascular - Other cardiovascular diseases

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Atrial Flutter Arrhythmia
Sponsor
Boston Scientific Corporation
Enrollment
20
Status
Recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 21, 2013
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •\* At least one (1\) documented episode of type I atrial flutter preceding enrollment documented by 12\-lead ECG, Holter monitor, rhythm strip, or trans telephonic monitor
  • •\* Subjects are clinically indicated for standard of care catheter ablation for type I atrial flutter
  • •\* Age 18 or above, or of legal age to give informed consent specific to state and national law
  • •\* Subjects or their legal representative are competent and willing to provide written informed consent to participate in the study and agree to (and are able to) comply with follow\-up visits and evaluation

Exclusion Criteria

  • •\* Any cardiac ablation within 90 days prior to enrollment
  • •\* Previous CTI ablation
  • •\* Cardiac surgery within 90 days prior to enrollment
  • •\* Myocardial infarction (MI) or cardiac revascularization (percutaneous coronary intervention) within 60 days prior to enrollment
  • •\* Current unstable angina
  • •\* Documented atrial or ventricular tumors, clots, thrombus, Deep Vein Thrombus (DVT)or have a known clotting disorder within 90 days prior to enrollment
  • •\* Implantation of permanent leads of an implantable device in or through the right atrium within 30 days prior to enrollment.

Outcomes

Primary Outcomes

Not specified

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