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

Phase 1

Recruiting

• Conditions: Atrial Flutter Arrhythmia; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12613000317796
• Lead Sponsor: Boston Scientific Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-03-21
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Immediately following the procedure, your doctor will demonstrate of bi-directional isthmus electrical block by recording electrical conduction within the heart using the IntellaTip MiFi™ XP System and other diagnostic catheters as part of routine care in these procedures.[acute; at the end of the procedure];Your doctor will evaluate any adverse events in participants exposed to the investigational devices during the procedure and at 7 days following the procedure. <br>[within 7 days of the procedure]

Secondary Outcome Measures

Name	Time	Method
Evaluation of electrogram data on the IntelliTip MiFi XP mini electrodes compared to the data captured via the common bipoles electrodes on the catheter.[acute; at time of procedure]