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IntellaTip MiFi XP Ablation Catheter Trial (MiFi-CTI)

Primary Purpose

Atrial Flutter

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
IntellaTip MiFi XP Catheter
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Flutter focused on measuring Atrial Flutter, Ablation, Type I Atrial Flutter, Atrial Arrhythmia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Royal Adelaide Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IntellaTip XP MiFi

Arm Description

Patients with Atrial Flutter will receive ablation treatment with the IntellaTip MiFi XP catheter

Outcomes

Primary Outcome Measures

Acute Procedural Success
The Demonstration of bi-directional isthmus block at the end of the ablation procedure

Secondary Outcome Measures

Complication Rate at procedure
Determine major complications in patients exposed to the device, which occur within 7 days of the procedure

Full Information

First Posted
November 16, 2012
Last Updated
May 2, 2017
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01730807
Brief Title
IntellaTip MiFi XP Ablation Catheter Trial
Acronym
MiFi-CTI
Official Title
IntellaTip MiFi XP Ablation Catheters First in Human Use Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Flutter
Keywords
Atrial Flutter, Ablation, Type I Atrial Flutter, Atrial Arrhythmia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IntellaTip XP MiFi
Arm Type
Experimental
Arm Description
Patients with Atrial Flutter will receive ablation treatment with the IntellaTip MiFi XP catheter
Intervention Type
Device
Intervention Name(s)
IntellaTip MiFi XP Catheter
Intervention Description
Temperature controlled ablation catheter
Primary Outcome Measure Information:
Title
Acute Procedural Success
Description
The Demonstration of bi-directional isthmus block at the end of the ablation procedure
Time Frame
one day
Secondary Outcome Measure Information:
Title
Complication Rate at procedure
Description
Determine major complications in patients exposed to the device, which occur within 7 days of the procedure
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prashanthan Sanders, MD
Organizational Affiliation
Royal Adelaide Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5001
Country
Australia

12. IPD Sharing Statement

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IntellaTip MiFi XP Ablation Catheter Trial

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