IntellaTip MiFi XP Ablation Catheter Trial

IntellaTip MiFi XP Ablation Catheters First in Human Use Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01730807

Acronym

MiFi-CTI

Enrollment

Registered

2012-11-21

Start date

2013-03-31

Completion date

2015-01-31

Last updated

2017-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Flutter

Keywords

Atrial Flutter, Ablation, Type I Atrial Flutter, Atrial Arrhythmia

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.

Interventions

DEVICEIntellaTip MiFi XP Catheter

Temperature controlled ablation catheter

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026