- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01730807
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.
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- MiFi-CTI
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.
Clinical Trials on Atrial Flutter
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Vivek ReddyEnrolling by invitationAtrial Fibrillation and Flutter | Atrial Flutter Typical | Atrial Fibrillation, Paroxysmal or PersistentUnited States
-
University of PennsylvaniaWithdrawnTypical Atrial Flutter | Risk Factors With Future Development of Atrial FlutterUnited States
-
Angelo BivianoCompleted
-
Kaiser PermanenteActive, not recruitingAtrial Fibrillation and FlutterUnited States
-
Charles University, Czech RepublicCompleted
-
Hospital Universitario Central de AsturiasJohnson & JohnsonUnknown
-
Hangzhou Dinova EP Technology Co., LtdNot yet recruiting
-
University of ManchesterManchester University NHS Foundation TrustWithdrawn
-
Abbott Medical DevicesCompletedTypical Atrial FlutterUnited States, Canada
-
Abbott Medical DevicesCompletedTypical Atrial FlutterUnited States, Canada
Clinical Trials on IntellaTip MiFi XP Catheter
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Emory UniversityBoston Scientific CorporationCompleted
-
University of FloridaCompletedAtrial FibrillationUnited States
-
Yong Seog OhCompletedParoxysmal Supraventricular TachycardiaKorea, Republic of
-
Biosense Webster, Inc.TerminatedAtrial FibrillationKorea, Republic of, Germany, Belgium, Norway, Austria, Ireland, United Kingdom, Australia, Spain, Sweden, Latvia, Hungary, Italy, Poland, Russian Federation
-
University Hospital HeidelbergZOLL Circulation, Inc., USAUnknownIschemic Stroke | Hypothermia | ThrombolysisGermany
-
WellStar Health SystemZoll Medical CorporationWithdrawnIschemic Stroke | HypothermiaUnited States