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NCT01730807 Clinical Trial

IntellaTip MiFi XP Ablation Catheter Trial

Atrial Flutter Clinical Trial

— MiFi-CTI  

Official title:
IntellaTip MiFi XP Ablation Catheters First in Human Use Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01730807
Other study ID # MiFi-CTI
Secondary ID
Status Completed
Phase N/A
First received November 16, 2012
Last updated May 2, 2017
Start date March 2013
Est. completion date January 2015

Study information
Verified date May 2017
Source Boston Scientific Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A study to assess the performance of a new catheter design for the treatment of Atrial Flutter.

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 information / eligibility
Status Completed
Enrollment 10
Est. completion date January 2015
Est. primary completion date February 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• IntellaTip MiFi XP Catheter
Temperature controlled ablation catheter

Locations
Country Name City State
Australia Royal Adelaide Hospital Adelaide South Australia

Sponsors (1)
Lead Sponsor Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

Australia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Acute Procedural Success The Demonstration of bi-directional isthmus block at the end of the ablation procedure one day
Secondary Complication Rate at procedure Determine major complications in patients exposed to the device, which occur within 7 days of the procedure 7 days
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