Atrial FibrillationPhase 3NCT00137540
FLAT Study: First Line Ablation Therapy for Treatment of Paroxysmal Atrial Fibrillation (RAAFT)
A Phase 3 study testing RF ablation and anti-arrhythmic drug therapy in people with Atrial Fibrillation, run by Biosense Webster EMEA.
Trial summary
The objective of this multicenter randomized study is to establish the effectiveness of treatment for paroxysmal atrial fibrillation (AF), in patients not previously treated with anti-arrhythmic drugs, by encircling the pulmonary veins with radiofrequency (RF) ablation, using the NaviStar® ThermoCool® catheter and the… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- RF ablation and anti-arrhythmic drug therapy
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Sep 2005to Jul 2008
- Phase
- Phase 3
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent obtained
- Two or more documented symptomatic paroxysmal atrial fibrillation episodes during the last 6 months. Episodes should last longer than 30 seconds.
- Patients should not be on anti-arrhythmic medication therapy (Class I, III or IV) for AF (other than for cardioversion) or are currently on antiarrhythmic drug (AAD) therapy for any other arrhythmia
Who cannot join
- Patients who had a previous ablation for atrial fibrillation
- Patients who had presence of severe valvular disease, myocardial infarction and/ or cardiomyopathy
- Patients with a left atrial size more than 50 mm
- Patients who had more than 2 cardioversions
- Patients who have a history of AF for less than 3 months or more than one year
- Patients with solely asymptomatic AF
Show all 19Show fewer
- Patients who have AF episodes triggered by another uniform arrhythmia
- Patients who actively abuse alcohol or other drugs, which may be causative of AF
- Patients with a tumor, or another abnormality which precludes catheter introduction
- Patients with a revascularization or other cardiac surgery within 6 months before study treatment
- Patients in whom appropriate vascular access is precluded
- Patients with a contraindication to treatment with warfarin or other bleeding diathesis participants in another investigational clinical or device trial
- Patients who are inaccessible for follow-up psychological problem that might limit compliance
- Patients who cannot or will not fulfill the follow-up or protocol requirements
- Pregnant women
- Patients with severe chronic obstructive pulmonary disease
- Patients with Wolff-Parkinson-White (WPW) syndrome
- Patients with renal failure requiring dialysis
- Patients with hepatic failure
About this study
Official title: First Line Radiofrequency Ablation vs. Antiarrhythmic Drugs for Atrial Fibrillation Treatment
The objective of this multicenter randomized study is to establish the effectiveness of treatment for paroxysmal atrial fibrillation (AF), in patients not previously treated with anti-arrhythmic drugs, by encircling the pulmonary veins with radiofrequency (RF) ablation, using the NaviStar® ThermoCool® catheter and the CARTO™ EP Navigation System. Effectiveness will be determined by comparing chronic success of ablation therapy versus anti-arrhythmic drug treatment, defined as patients with an absence of atrial tachycardias during 24 months of follow-up as determined by 7-days Holter and transtelephonic monitoring, and by 12-lead electrocardiogram (ECG) recordings.
Read the detailed description
This study is a prospective, randomized, multicenter clinical study that will enroll in its first phase 40 patients. The study will be performed in 3 European hospitals. Patients will be randomized to either the RF ablation strategy or to the medication arm.
Hypothesis:
As first line therapy, catheter ablation improves the long-term success, health-economic outcomes and is equally safe compared to the best anti-arrhythmic medication treatment in a selected group of patients with paroxysmal atrial fibrillation.
Primary endpoint:
- long-term success, defined as patients free from any atrial fibrillation during 24 months after initial study treatment as determined by 7-days Holter and transtelephonic monitoring and by 12-lead ECG recordings.
Secondary endpoints:
- AF burden: frequency and duration of episodes
- health-economic costs over 24 months
- serious adverse events
- Quality of Life scores, using SF-36 questionnaire
- Conditions
- Atrial Fibrillation
- Being tested
- RF ablation, anti-arrhythmic drug therapy
- Keywords
- First line ablation therapy
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RF ablationDevice
anti-arrhythmic drug therapyDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
long-term success
Measured: 19 months
Secondary outcomes (4)
AF-burden
Measured: 19 months
health-economic costs
Measured: 24 months
serious adverse events
Measured: 19 months
Quality of Life scores
Measured: 19 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2005 (estimated)
- Study startSep 2005
- Primary completionApr 2007
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biosense Webster EMEA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- F. Gaita, Prof., Principal investigator, Ospedale Civile, Asti, ItalyP. Della Bella, MD, Principal investigator, Centro Cardiologico Monzino, Milan, ItalyM. Fiala, MD, Principal investigator, Nemocnice Podlesi, Trinec, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00137540
- Sponsor's protocol ID
- FLAT
- Status last verified
- Jan 2025
- First submitted
- 29 Aug 2005
- Last updated
- 3 Feb 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First Line Radiofrequency Ablation vs. Antiarrhythmic Drugs for Atrial Fibrillation Treatment
- ClinicalTrials.gov ID
- NCT00137540
- Acronym / sponsor ID
- FLAT
- Conditions
- Atrial Fibrillation
- Keywords
- First line ablation therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Biosense Webster EMEAIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- Apr 2007 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 30 Aug 2005 (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 objective of this multicenter randomized study is to establish the effectiveness of treatment for paroxysmal atrial fibrillation (AF), in patients not previously treated with anti-arrhythmic drugs, by encircling the pulmonary veins with radiofrequency (RF) ablation, using the NaviStar® ThermoCool® catheter and the CARTO™ EP Navigation System. Effectiveness will be determined by comparing chronic success of ablation therapy versus anti-arrhythmic drug treatment, defined as patients with an absence of atrial tachycardias during 24 months of follow-up as determined by 7-days Holter and transtelephonic monitoring, and by 12-lead electrocardiogram (ECG) recordings.
Detailed description
This study is a prospective, randomized, multicenter clinical study that will enroll in its first phase 40 patients. The study will be performed in 3 European hospitals. Patients will be randomized to either the RF ablation strategy or to the medication arm.
Hypothesis:
As first line therapy, catheter ablation improves the long-term success, health-economic outcomes and is equally safe compared to the best anti-arrhythmic medication treatment in a selected group of patients with paroxysmal atrial fibrillation.
Primary endpoint:
- long-term success, defined as patients free from any atrial fibrillation during 24 months after initial study treatment as determined by 7-days Holter and transtelephonic monitoring and by 12-lead ECG recordings.
Secondary endpoints:
- AF burden: frequency and duration of episodes
- health-economic costs over 24 months
- serious adverse events
- Quality of Life scores, using SF-36 questionnaire
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Informed consent obtained
- Two or more documented symptomatic paroxysmal atrial fibrillation episodes during the last 6 months. Episodes should last longer than 30 seconds.
- Patients should not be on anti-arrhythmic medication therapy (Class I, III or IV) for AF (other than for cardioversion) or are currently on antiarrhythmic drug (AAD) therapy for any other arrhythmia
Key exclusion criteria (19 listed)
- Patients who had a previous ablation for atrial fibrillation
- Patients who had presence of severe valvular disease, myocardial infarction and/ or cardiomyopathy
- Patients with a left atrial size more than 50 mm
- Patients who had more than 2 cardioversions
- Patients who have a history of AF for less than 3 months or more than one year
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 |
|---|---|---|
| RF ablation | Device | – |
| anti-arrhythmic drug therapy | Drug | – |
Primary outcome
long-term success
Time frame: 19 months
4 secondary outcomes
AF-burden
Time frame: 19 months
health-economic costs
Time frame: 24 months
serious adverse events
Time frame: 19 months
Quality of Life scores
Time frame: 19 months
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 3 Feb 2025.
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Atrial Fibrillation (AF)
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.
F. Gaita, Prof. principal investigator
Ospedale Civile, Asti, Italy
P. Della Bella, MD principal investigator
Centro Cardiologico Monzino, Milan, Italy
M. Fiala, MD principal investigator
Nemocnice Podlesi, Trinec, Czech Republic
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing RF ablation and anti-arrhythmic drug therapy in people with Atrial Fibrillation, run by Biosense Webster EMEA.
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 3 inclusion and 19 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 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
long-term success (time frame: 19 months). 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 3 Feb 2025.