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OpenTrials
Completed

NCT Number: NCT01730807

IntellaTip MiFi XP Ablation Catheter Trial

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

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Key information

Conditions

Atrial Flutter Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Adelaide Hospital

Adelaide, South Australia, 5001, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IntellaTip MiFi XP Catheter

Device

Temperature controlled ablation catheter

Primary outcomes

  1. Acute Procedural Success

    Time frame: one day

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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

IntellaTip MiFi XP Ablation Catheters First in Human Use Trial

Acronym: MiFi-CTI

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Nov 21, 2012
Registry last updated
May 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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