IntellaTip MiFi XP Ablation Catheter Trial (MiFi-CTI)

May 2, 2017 updated by: Boston Scientific Corporation

IntellaTip MiFi XP Ablation Catheters First in Human Use Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • South Australia
      • Adelaide, South Australia, Australia, 5001
        • Royal Adelaide Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IntellaTip XP MiFi
Patients with Atrial Flutter will receive ablation treatment with the IntellaTip MiFi XP catheter
Temperature controlled ablation catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute Procedural Success
Time Frame: one day
The Demonstration of bi-directional isthmus block at the end of the ablation procedure
one day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complication Rate at procedure
Time Frame: 7 days
Determine major complications in patients exposed to the device, which occur within 7 days of the procedure
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Prashanthan Sanders, MD, Royal Adelaide Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

November 16, 2012

First Submitted That Met QC Criteria

November 20, 2012

First Posted (Estimate)

November 21, 2012

Study Record Updates

Last Update Posted (Actual)

May 4, 2017

Last Update Submitted That Met QC Criteria

May 2, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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