Paroxysmal Atrial FibrillationAFLIT-PAFNCT01466842
Ablation as First Line Treatment in Paroxysmal Atrial Fibrillation
A study testing Catheter ablation using cryothermia in people with Paroxysmal Atrial Fibrillation, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
The purpose of this study is to determine whether catheter ablation is more effective than antiarrhythmic drugs in the early stages of paroxysmal atrial fibrillation. In all the patients a subcutaneous loop recorder will be implanted. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Paroxysmal Atrial Fibrillation
- What is being tested?
- Catheter ablation using cryothermia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2012to Jan 2016
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 65
- At least three episodes of paroxysmal atrial fibrillation documented on an electrocardiogram or event recording during the last three years
- Never taken antiarrhythmic drugs or at most a pill in the pocket approach
- Willingness, ability and commitment to participate in baseline and follow-up evaluations
Who cannot join
- Paroxysmal AF for more than three years
- An episode of atrial fibrillation that lasted more than seven days within the past six months
- Persistent/permanent atrial fibrillation
- Atrial fibrillation from reversible cause (i.e. surgery, hyperthyroidism, pericarditis)
- Documented atrial flutter
- Structural heart disease of clinical significance including:
Show all 23Show fewer
- Cardiac surgery within six months of screening
- Unstable symptoms of congestive heart failure (CHF) including NYHA Class III or IV CHF at screening and/or ejection fraction <30% as measured by echocardiography or catheterization
- Unstable angina
- Myocardial infarction within six months of screening
- Surgically corrected atrial septal defect with a patch or closure device
- LA size > 40mm
- Any prior ablation of the pulmonary veins
- Enrollment in any other ongoing protocol
- Untreatable allergy to contrast media
- Pregnancy
- Any contraindication to cardiac catheterization
- Prosthetic mitral heart valve
- Poor general health that, in the opinion of the Investigator, will not allow the patient to be a good study candidate (i.e. other disease processes, mental capacity, etc.)
- Contraindication to coumadin or heparin
- History of pulmonary embolus or stroke within one year of screening
- Acute pulmonary edema
- Atrial clot on TEE regardless of the patient's anticoagulation medication status
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Centre
Maastricht, 6229 HX
Suzanne Philippens, + 31 43 3877095, s.philippens@mumc.nl
Laurent Pison Pison, MD
About this study
The purpose of this study is to determine whether catheter ablation is more effective than antiarrhythmic drugs in the early stages of paroxysmal atrial fibrillation. In all the patients a subcutaneous loop recorder will be implanted.
- Conditions
- Paroxysmal Atrial Fibrillation
- Being tested
- Catheter ablation using cryothermia
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter ablation using cryothermiaProcedure or surgery
Three months before the catheter ablation procedure, a subcutaneous loop recorder will be implanted. The ablation procedure will be performed using cryothermia.
| Study group | Role | What they receive |
|---|---|---|
| Catheter ablation | Other | Not described Receives: Procedure: Catheter ablation using cryothermia |
| Antiarrhythmic drugs | No intervention | Three months before starting antiarrhythmic drugs, a subcutaneous loop recorder will be implanted. |
What is being measured
The primary outcome is the main question the study is designed to answer.
any recurrence of symptomatic AF or asymptomatic AF and atrial flutter/tachycardia in the absence of AAD therapy during a follow-up period of 6 months
Measured: 6 months
Secondary outcomes (4)
any recurrence of symptomatic AF or asymptomatic AF and atrial flutter/tachycardia in the absence of AAD therapy after the initial six months follow-up
Measured: 3 years
comparison of the subjective findings of recurrence of AF by the patient through QoL and symptom questionnaires
Measured: 3, 6, 12, 24 and 36 months
number of track complications, both acute (during the procedure) and chronic throughout the trial
Measured: 3 years
hospitalization rate during a two and a half year follow-up following the initial six months follow-up
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2011 (estimated)
- Study startJan 2012
- Primary completionJan 2013 (estimated)
- Study completionJan 2016 (estimated)
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 Maastricht University Medical CenterThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01466842
- Sponsor's protocol ID
- AFLIT-PAF 1.2
- Acronym
- AFLIT-PAF
- Status last verified
- Nov 2011
- First submitted
- 3 Nov 2011
- Last updated
- 8 Nov 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ablation as First Line Treatment in Paroxysmal Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT01466842
- Acronym / sponsor ID
- AFLIT-PAF / AFLIT-PAF 1.2
- Conditions
- Paroxysmal Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2013 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 8 Nov 2011 (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 determine whether catheter ablation is more effective than antiarrhythmic drugs in the early stages of paroxysmal atrial fibrillation. In all the patients a subcutaneous loop recorder will be implanted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Catheter ablation | Other | Procedure: Catheter ablation using cryothermia |
| Antiarrhythmic drugs | No intervention | –Three months before starting antiarrhythmic drugs, a subcutaneous loop recorder will be implanted. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 18 and 65
- At least three episodes of paroxysmal atrial fibrillation documented on an electrocardiogram or event recording during the last three years
- Never taken antiarrhythmic drugs or at most a pill in the pocket approach
- Willingness, ability and commitment to participate in baseline and follow-up evaluations
Key exclusion criteria (23 listed)
- Paroxysmal AF for more than three years
- An episode of atrial fibrillation that lasted more than seven days within the past six months
- Persistent/permanent atrial fibrillation
- Atrial fibrillation from reversible cause (i.e. surgery, hyperthyroidism, pericarditis)
- Documented atrial flutter
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 |
|---|---|---|
| Catheter ablation using cryothermiaThree months before the catheter ablation procedure, a subcutaneous loop recorder will be implanted. The ablation procedure will be performed using cryothermia. | Procedure or surgery | Catheter ablation |
Primary outcome
any recurrence of symptomatic AF or asymptomatic AF and atrial flutter/tachycardia in the absence of AAD therapy during a follow-up period of 6 months
Time frame: 6 months
4 secondary outcomes
any recurrence of symptomatic AF or asymptomatic AF and atrial flutter/tachycardia in the absence of AAD therapy after the initial six months follow-up
Time frame: 3 years
comparison of the subjective findings of recurrence of AF by the patient through QoL and symptom questionnaires
Time frame: 3, 6, 12, 24 and 36 months
number of track complications, both acute (during the procedure) and chronic throughout the trial
Time frame: 3 years
hospitalization rate during a two and a half year follow-up following the initial six months follow-up
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2011.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Catheter ablation using cryothermia in people with Paroxysmal Atrial Fibrillation, run by Maastricht University Medical Center at 1 site in Netherlands.
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 23 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: status not confirmed, as of the sponsor's last update on 8 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laurent Pison, MD (+ 31 43 3877095, l.pison@mumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
any recurrence of symptomatic AF or asymptomatic AF and atrial flutter/tachycardia in the absence of AAD therapy during a follow-up period of 6 months (time frame: 6 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 8 Nov 2011.