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IntellaTip MiFi XP Ablation Catheter Trial (MiFi-CTI)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01730807
First received: November 16, 2012
Last updated: May 2, 2017
Last verified: May 2017
  Purpose
A study to assess the performance of a new catheter design for the treatment of Atrial Flutter.

Condition Intervention
Atrial Flutter Device: IntellaTip MiFi XP Catheter

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: IntellaTip MiFi XP Ablation Catheters First in Human Use Trial

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Acute Procedural Success [ Time Frame: one day ]
    The Demonstration of bi-directional isthmus block at the end of the ablation procedure


Secondary Outcome Measures:
  • 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


Enrollment: 10
Study Start Date: March 2013
Study Completion Date: January 2015
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IntellaTip XP MiFi
Patients with Atrial Flutter will receive ablation treatment with the IntellaTip MiFi XP catheter
Device: IntellaTip MiFi XP Catheter
Temperature controlled ablation catheter

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01730807

Locations
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5001
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: Prashanthan Sanders, MD Royal Adelaide Hospital
  More Information

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01730807     History of Changes
Other Study ID Numbers: MiFi-CTI
Study First Received: November 16, 2012
Last Updated: May 2, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Boston Scientific Corporation:
Atrial Flutter
Ablation
Type I Atrial Flutter
Atrial Arrhythmia

Additional relevant MeSH terms:
Atrial Flutter
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 22, 2017