Paroxysmal Atrial FibrillationPhase 2FACT-AFNCT01185613
Clinical Evaluation of Therapy™ Cool Flex Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation
A Phase 2 study testing Therapy™ Cool Flex Ablation Catheter in people with Paroxysmal Atrial Fibrillation, run by Abbott Medical Devices at 6 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paroxysmal Atrial Fibrillation
- What is being tested?
- Therapy™ Cool Flex Ablation Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 6 sitesin 6 countries
- Study dates
- Jun 2010to Sep 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
6 sites in 6 countries.
6 sites in 6 countries
About this study
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.
- Conditions
- Paroxysmal Atrial Fibrillation
- Being tested
- Therapy™ Cool Flex Ablation Catheter
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapy™ Cool Flex Ablation CatheterDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Therapy™ Cool Flex Ablation Catheter | Experimental | Not described Receives: Device: Therapy™ Cool Flex Ablation Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
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.
Measured: 6 months
Serious Adverse Events
All serious adverse events through six month follow-up
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2010 (estimated)
- Study startJun 2010
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paroxysmal Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01185613
- Sponsor's protocol ID
- AF-09-024-EU-AB
- Acronym
- FACT-AF
- Status last verified
- Feb 2019
- First submitted
- 18 Aug 2010
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Therapy™ Cool Flex Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT01185613
- Acronym / sponsor ID
- FACT-AF / AF-09-024-EU-AB
- Conditions
- Paroxysmal Atrial Fibrillation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 20 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Therapy™ Cool Flex Ablation Catheter | Experimental | Device: Therapy™ Cool Flex Ablation Catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapy™ Cool Flex Ablation CatheterThe 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 | Device | Therapy™ Cool Flex Ablation Catheter |
Primary outcome
Procedural parameters
Time frame: 6 months
* 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
Time frame: 6 months
* 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
Time frame: 6 months
All serious adverse events through six month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Therapy™ Cool Flex Ablation Catheter in people with Paroxysmal Atrial Fibrillation, run by Abbott Medical Devices at 6 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Australia, France, Germany, Italy, Portugal and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedural parameters (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2019; AzTrials last refreshed its copy on 7 Nov 2026.