Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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 details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01730807




Registration number
NCT01730807
Ethics application status
Date submitted
16/11/2012
Date registered
21/11/2012
Date last updated
4/05/2017

Titles & IDs
Public title
IntellaTip MiFi XP Ablation Catheter Trial
Scientific title
IntellaTip MiFi XP Ablation Catheters First in Human Use Trial
Secondary ID [1] 0 0
MiFi-CTI
Universal Trial Number (UTN)
Trial acronym
MiFi-CTI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Flutter 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - IntellaTip MiFi XP Catheter

Experimental: IntellaTip XP MiFi - Patients with Atrial Flutter will receive ablation treatment with the IntellaTip MiFi XP catheter


Treatment: Devices: IntellaTip MiFi XP Catheter
Temperature controlled ablation catheter
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Acute Procedural Success
Timepoint [1] 0 0
one day
Secondary outcome [1] 0 0
Complication Rate at procedure
Timepoint [1] 0 0
7 days

Eligibility
Key inclusion criteria
* 18 or older
* indicated for ablation for Atrial Flutter
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Thrombus
* Recent MI/cardiac revascularization
* Prosthetic Valves
* recent ablation for atrial flutter
* atrial flutter with reversible cause
* Class IV HF

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2015
Sample size
Target
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
5001 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boston Scientific Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Prashanthan Sanders, MD
Address 0 0
Royal Adelaide Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01730807