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Trial registered on ANZCTR
Registration number
ACTRN12613000317796
Ethics application status
Approved
Date submitted
19/03/2013
Date registered
21/03/2013
Date last updated
21/03/2013
Type of registration
Retrospectively registered
Titles & IDs
Public title
Feasibility Study to assess the performance of IntellaTip MiFi™ XP Temperature Ablation Catheter System for the treatment of Subjects with Sustained or Recurrent Type I Atrial Flutter
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Scientific title
Feasibility Study to assess the performance of IntellaTip MiFi™ XP Temperature Ablation Catheter System for the treatment of Subjects with Sustained or Recurrent Type I Atrial Flutter
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Secondary ID [1]
282148
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nil
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Universal Trial Number (UTN)
U1111-1140-7527
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Trial acronym
MiFi CTI
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Atrial Flutter Arrhythmia
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Condition category
Condition code
Cardiovascular
288992
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0
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Cardiac Radiofrequency Ablation
A radiofrequency ablation catheter, IntelliTip MiFi™ XP, will be used to deliver energy to the cardiac tissue to create a line of scar (through heat) to the cavotricuspid isthmus in patients with Type I atrial flutter. The total procedure duration may last 1-5 hours, but typically does not take longer than 2 hours. A participant in the trial will undergo the procedure 1 time and will be seen at one week following the procedure to evaluate the participant.
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Intervention code [1]
286754
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Treatment: Devices
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Comparator / control treatment
A control or comparator is not being evaluated in this study.
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Immediately following the procedure, your doctor will demonstrate of bi-directional isthmus electrical block by recording electrical conduction within the heart using the IntellaTip MiFi™ XP System and other diagnostic catheters as part of routine care in these procedures.
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Assessment method [1]
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Timepoint [1]
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acute; at the end of the procedure
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Primary outcome [2]
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Your doctor will evaluate any adverse events in participants exposed to the investigational devices during the procedure and at 7 days following the procedure.
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Assessment method [2]
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Timepoint [2]
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within 7 days of the procedure
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Secondary outcome [1]
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Evaluation of electrogram data on the IntelliTip MiFi XP mini electrodes compared to the data captured via the common bipoles electrodes on the catheter.
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Assessment method [1]
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Timepoint [1]
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acute; at time of procedure
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Eligibility
Key inclusion criteria
* At least one (1) documented episode of type I atrial flutter preceding enrollment documented by 12-lead ECG, Holter monitor, rhythm strip, or trans telephonic monitor
* Subjects are clinically indicated for standard of care catheter ablation for type I atrial flutter
* Age 18 or above, or of legal age to give informed consent specific to state and national law
* Subjects or their legal representative are competent and willing to provide written informed consent to participate in the study and agree to (and are able to) comply with follow-up visits and evaluation
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Any cardiac ablation within 90 days prior to enrollment
* Previous CTI ablation
* Cardiac surgery within 90 days prior to enrollment
* Myocardial infarction (MI) or cardiac revascularization (percutaneous coronary intervention) within 60 days prior to enrollment
* Current unstable angina
* Documented atrial or ventricular tumors, clots, thrombus, Deep Vein Thrombus (DVT)or have a known clotting disorder within 90 days prior to enrollment
* Implantation of permanent leads of an implantable device in or through the right atrium within 30 days prior to enrollment.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects who meet inclusion and exclusion criteria and consented to trialwill be enrolled and treated with the investigational device
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This is a non-randomised trial
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 0
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
This study will include enrollment of up to 20 subjects, in order to obtain a total of ten (10) complete data sets. No formal statistical hypotheses will be done, due to the small sample size. Descriptive statistics will be used to report adverse events and device performance, including mean, minimum, maximum, and standard deviation.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
4/03/2013
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Actual
4/03/2013
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Date of last participant enrolment
Anticipated
22/05/2013
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
20
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
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The Royal Adelaide Hospital - Adelaide
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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Boston Scientific Corporation
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Address [1]
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4100 Hamline Ave. N
Mailstop 9-321
St. Paul, MN 55112
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Country [1]
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United States of America
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Primary sponsor type
Commercial sector/Industry
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Name
Boston Scientific Corporation
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Address
4100 Hamline Ave. N
Mailstop 9-321
St. Paul, MN 55112
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Country
United States of America
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
285701
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Royal Adelaide Hospital HREC
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Ethics committee address [1]
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North Terrace
Adelaide SA 5000
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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29/01/2013
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Approval date [1]
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11/02/2013
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Ethics approval number [1]
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HREC/12/RAH/164
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Summary
Brief summary
The ablation procedure uses tools called catheters to treat the atrial flutter. Ablation catheters are thin, flexible plastic tubes that use electrical energy to stop abnormal heart rhythms by heating (ablating) and destroying a small area of tissue to break the abnormal pathway. The purpose of this study is to evaluate the safety, performance and effectiveness (success) of a new ablation catheter that is used to treat atrial flutter. The new catheter is called the Intellitip MiFi XP Ablation Catheter. The catheter is made by the company Boston Scientific Corporation, who is also the sponsor of this research study.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Prash Sanders
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Address
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Royal Adelaide Hospital
Centre for Heart Rhythm Disorders
L5, McEwin Building
Cardiology Department
Royal Adelaide Hospital
North Terrace
ADELAIDE
SOUTH AUSTRALIA 5001
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Country
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Australia
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Phone
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+61 8 82225669
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Mr Bryan Wylie
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Address
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Boston Scientific
150 Baytech Parkway
San Jose, CA 95134
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Country
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United States of America
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Phone
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+14089356166
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Prof Prash Sanders
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Address
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Royal Adelaide Hospital
Centre for Heart Rhythm Disorders
L5, McEwin Building
Cardiology Department
Royal Adelaide Hospital
North Terrace
ADELAIDE
SOUTH AUSTRALIA 5001
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Country
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Australia
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Phone
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+61 8 82225669
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Fax
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Email
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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