Clinical Evaluation of Therapy™ Cool Flex Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation (FACT-AF)
Primary Purpose
Paroxysmal Atrial Fibrillation
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Therapy™ Cool Flex Ablation Catheter
Sponsored by
About this trial
This is an interventional other trial for Paroxysmal Atrial Fibrillation
Eligibility Criteria
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
Sites / Locations
- Royal Adelaide Hospital
- Hopital du Haut Leveque
- Universitat Leipzig Herzzentrum
- Ospendale dell'Angelo
- Hospital Santa Cruz
- Heart Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Therapy™ Cool Flex Ablation Catheter
Arm Description
Outcomes
Primary Outcome Measures
Procedural parameters
Ablation parameters (such as average power delivered , average tip temperature , average impedance )
Lesion locations (such as PVI, Septal line, Mitral isthmus, CTI or any other lesion location)
Mapping techniques (Mapping system and catheter)
RF application time ( Calculated from the total number of RF application and duration of each RF application)
Ablation procedure time (Time from the first to the last RF application)
Total irrigation fluid administered during ablation procedure
Fluoroscopy time
AF Recurrence
Recurrence of AF through six months post last RF ablation procedure using Cool Flex catheter. A 24 hour Holter will be provided to the patients for six month follow-up visit in order to monitor AF episodes. An AF episode will be considered a recurrence only if it lasts for 30 seconds or more.
AF recurrences during the blanking period (defined below) will not be reported.
Serious Adverse Events
All serious adverse events through six month follow-up
Secondary Outcome Measures
Full Information
NCT ID
NCT01185613
First Posted
August 18, 2010
Last Updated
February 1, 2019
Sponsor
Abbott Medical Devices
1. Study Identification
Unique Protocol Identification Number
NCT01185613
Brief Title
Clinical Evaluation of Therapy™ Cool Flex Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation
Acronym
FACT-AF
Official Title
Clinical Evaluation of Therapy™ Cool Flex Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Abbott Medical Devices
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Atrial Fibrillation
7. Study Design
Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Therapy™ Cool Flex Ablation Catheter
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Therapy™ Cool Flex Ablation Catheter
Intervention Description
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
Primary Outcome Measure Information:
Title
Procedural parameters
Description
Ablation parameters (such as average power delivered , average tip temperature , average impedance )
Lesion locations (such as PVI, Septal line, Mitral isthmus, CTI or any other lesion location)
Mapping techniques (Mapping system and catheter)
RF application time ( Calculated from the total number of RF application and duration of each RF application)
Ablation procedure time (Time from the first to the last RF application)
Total irrigation fluid administered during ablation procedure
Fluoroscopy time
Time Frame
6 months
Title
AF Recurrence
Description
Recurrence of AF through six months post last RF ablation procedure using Cool Flex catheter. A 24 hour Holter will be provided to the patients for six month follow-up visit in order to monitor AF episodes. An AF episode will be considered a recurrence only if it lasts for 30 seconds or more.
AF recurrences during the blanking period (defined below) will not be reported.
Time Frame
6 months
Title
Serious Adverse Events
Description
All serious adverse events through six month follow-up
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Royal Adelaide Hospital
City
Adelaide
Country
Australia
Facility Name
Hopital du Haut Leveque
City
Pessac
Country
France
Facility Name
Universitat Leipzig Herzzentrum
City
Leipzig
Country
Germany
Facility Name
Ospendale dell'Angelo
City
Mestre
Country
Italy
Facility Name
Hospital Santa Cruz
City
Lisbon
Country
Portugal
Facility Name
Heart Hospital
City
London
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Clinical Evaluation of Therapy™ Cool Flex Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation
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