Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
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
Secondary ID [1] 282148 0
nil
Universal Trial Number (UTN)
U1111-1140-7527
Trial acronym
MiFi CTI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Flutter Arrhythmia 288651 0
Condition category
Condition code
Cardiovascular 288992 288992 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 286754 0
Treatment: Devices
Comparator / control treatment
A control or comparator is not being evaluated in this study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289104 0
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.
Timepoint [1] 289104 0
acute; at the end of the procedure
Primary outcome [2] 289105 0
Your doctor will evaluate any adverse events in participants exposed to the investigational devices during the procedure and at 7 days following the procedure.
Timepoint [2] 289105 0
within 7 days of the procedure
Secondary outcome [1] 301827 0
Evaluation of electrogram data on the IntelliTip MiFi XP mini electrodes compared to the data captured via the common bipoles electrodes on the catheter.
Timepoint [1] 301827 0
acute; at time of procedure

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This is a non-randomised trial
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 0
Type of endpoint/s
Safety/efficacy
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.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/03/2013
Actual
4/03/2013
Date of last participant enrolment
Anticipated
22/05/2013
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 781 0
The Royal Adelaide Hospital - Adelaide

Funding & Sponsors
Funding source category [1] 286914 0
Commercial sector/Industry
Name [1] 286914 0
Boston Scientific Corporation
Country [1] 286914 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Boston Scientific Corporation
Address
4100 Hamline Ave. N
Mailstop 9-321
St. Paul, MN 55112
Country
United States of America
Secondary sponsor category [1] 285701 0
None
Name [1] 285701 0
Address [1] 285701 0
Country [1] 285701 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288972 0
Royal Adelaide Hospital HREC
Ethics committee address [1] 288972 0
North Terrace
Adelaide SA 5000
Ethics committee country [1] 288972 0
Australia
Date submitted for ethics approval [1] 288972 0
29/01/2013
Approval date [1] 288972 0
11/02/2013
Ethics approval number [1] 288972 0
HREC/12/RAH/164

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38586 0
Prof Prash Sanders
Address 38586 0
Royal Adelaide Hospital
Centre for Heart Rhythm Disorders
L5, McEwin Building
Cardiology Department
Royal Adelaide Hospital
North Terrace
ADELAIDE
SOUTH AUSTRALIA 5001
Country 38586 0
Australia
Phone 38586 0
+61 8 82225669
Fax 38586 0
Email 38586 0
prash.sanders@adelaide.edu.au
Contact person for public queries
Name 38587 0
Mr Bryan Wylie
Address 38587 0
Boston Scientific
150 Baytech Parkway
San Jose, CA 95134
Country 38587 0
United States of America
Phone 38587 0
+14089356166
Fax 38587 0
Email 38587 0
bryan.wylie@bsci.com
Contact person for scientific queries
Name 38588 0
Prof Prash Sanders
Address 38588 0
Royal Adelaide Hospital
Centre for Heart Rhythm Disorders
L5, McEwin Building
Cardiology Department
Royal Adelaide Hospital
North Terrace
ADELAIDE
SOUTH AUSTRALIA 5001
Country 38588 0
Australia
Phone 38588 0
+61 8 82225669
Fax 38588 0
Email 38588 0
prash.sanders@adelaide.edu.au

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.