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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01185613




Registration number
NCT01185613
Ethics application status
Date submitted
18/08/2010
Date registered
20/08/2010
Date last updated
4/02/2019

Titles & IDs
Public title
Clinical Evaluation of Therapy™ Cool Flex Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation
Scientific title
Clinical Evaluation of Therapy™ Cool Flex Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation
Secondary ID [1] 0 0
AF-09-024-EU-AB
Universal Trial Number (UTN)
Trial acronym
FACT-AF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Paroxysmal Atrial Fibrillation 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Therapy™ Cool Flex Ablation Catheter

Experimental: Therapy™ Cool Flex Ablation Catheter -


Treatment: Devices: Therapy™ Cool Flex Ablation Catheter
The device under evaluation is the 4mm Therapy™ Cool Flex Ablation Catheter. The Therapy™ Cool Flex catheter is a flexible tip, insulated, 7F catheter constructed of thermoplastic elastomer material and noble metal electrodes.
The following CE Mark devices will be used in conjunction with the Therapy™ Cool Flex Ablation Catheter
IBI-1500T11 Cardiac Ablation Generator (RF ablation generator) with software version 3.0 or higher.
Cool Point™ Irrigation Pump
Cool Point™ Tubing set
Data Logger
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Procedural parameters
Timepoint [1] 0 0
6 months
Primary outcome [2] 0 0
AF Recurrence
Timepoint [2] 0 0
6 months
Primary outcome [3] 0 0
Serious Adverse Events
Timepoint [3] 0 0
6 months

Eligibility
Key inclusion criteria
- A signed written Informed Consent form

- 18 years of age or older

- Agrees to comply with follow-up visits and evaluation

- Candidate for catheter ablation for the treatment of paroxysmal atrial fibrillation as
per the hospital standard of care.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Persistent or Long standing AF

- CABG procedure within the last 180 days (six months).

- Documented left atrial thrombus on imaging [e.g. Transesophageal echocardiogram
(TEE)].

- History of blood clotting or bleeding abnormalities.

- Contraindication to anticoagulation (i.e. heparin or warfarin).

- Enrollment in another investigational study evaluating device or drug that might
impact the results of this study.

- Women who are pregnant (by history of menstrual period or pregnancy test if the
history is considered unreliable).

- Acute illness or active systemic infection or sepsis.

- Life expectancy less than 12 months.

- Uncontrolled heart failure or NYHA class IV heart failure.

- Myocardial Infarction within 8 weeks of enrollment or unstable angina

Study design
Purpose of the study
Other
Allocation to intervention
Non-randomised trial
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
Phase 2
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
1/06/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2011
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
Pessac
Country [2] 0 0
Germany
State/province [2] 0 0
Leipzig
Country [3] 0 0
Italy
State/province [3] 0 0
Mestre
Country [4] 0 0
Portugal
State/province [4] 0 0
Lisbon
Country [5] 0 0
United Kingdom
State/province [5] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Abbott Medical Devices
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to observe the performance of Therapy™ Cool Flex™ catheter by
documenting the procedural parameters, major complications and recurrence of AF after
ablation using Cool Flex ablation catheter for the treatment of paroxysmal atrial
fibrillation.

This study is an observational clinical study which is not based on any specific endpoints.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01185613
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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/ct2/show/NCT01185613