- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01185613
Clinical Evaluation of Therapy™ Cool Flex Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation (FACT-AF)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Adelaide, Australia
- Royal Adelaide Hospital
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Pessac, France
- Hôpital du Haut Lévêque
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Leipzig, Germany
- Universität Leipzig Herzzentrum
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Mestre, Italy
- Ospendale dell'Angelo
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Lisbon, Portugal
- Hospital Santa Cruz
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London, United Kingdom
- Heart Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Therapy™ Cool Flex Ablation Catheter
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Procedural parameters
Time Frame: 6 months
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6 months
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AF Recurrence
Time Frame: 6 months
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6 months
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Serious Adverse Events
Time Frame: 6 months
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All serious adverse events through six month follow-up
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6 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AF-09-024-EU-AB
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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