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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
Not applicable
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
Not applicable
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
A study to assess the performance of a new catheter design for the treatment of Atrial Flutter.
Trial website
https://clinicaltrials.gov/study/NCT01730807
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01730807