IntellaTip MiFi XP Ablation Catheter Trial

NCT ID: NCT01730807

Last Updated: 2017-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2015-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Atrial Flutter

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IntellaTip XP MiFi

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

Group Type EXPERIMENTAL

IntellaTip MiFi XP Catheter

Intervention Type DEVICE

Temperature controlled ablation catheter

Interventions

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IntellaTip MiFi XP Catheter

Temperature controlled ablation catheter

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Scientific Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Prashanthan Sanders, MD

Role: PRINCIPAL_INVESTIGATOR

Royal Adelaide Hospital

Locations

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Royal Adelaide Hospital

Adelaide, South Australia, Australia

Site Status

Countries

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Australia

Other Identifiers

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MiFi-CTI

Identifier Type: -

Identifier Source: org_study_id

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