IntellaTip MiFi XP Ablation Catheter Trial
Not Applicable
Completed
- Conditions
- Atrial Flutter
- Registration Number
- NCT01730807
- Lead Sponsor
- Boston Scientific Corporation
- Brief Summary
A study to assess the performance of a new catheter design for the treatment of Atrial Flutter.
- Detailed Description
A prospective, non-blinded, single arm, single center study designed to assess the performance of the IntellaTip MiFi XP Ablation Catheter for the treatment of recurrent or sustained type I atrial Flutter.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
- 18 or older
- indicated for ablation for Atrial Flutter
Exclusion Criteria
- Thrombus
- Recent MI/cardiac revascularization
- Prosthetic Valves
- recent ablation for atrial flutter
- atrial flutter with reversible cause
- Class IV HF
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Acute Procedural Success one day The Demonstration of bi-directional isthmus block at the end of the ablation procedure
- Secondary Outcome Measures
Name Time Method Complication Rate at procedure 7 days Determine major complications in patients exposed to the device, which occur within 7 days of the procedure
Trial Locations
- Locations (1)
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
Royal Adelaide Hospital🇦🇺Adelaide, South Australia, Australia