Atrial FibrillationPhase 4METACSANCT02389218
A Prospective Study of Medical Therapy Against Cryoballoon Ablation in Symptomatic Recent Onset Persistent AF
A Phase 4 study testing single ablation (CryoBalloonAblation (CBA) and sequential drug adjustment (propafenone, sotalol or flecainide) in people with Atrial Fibrillation, run by University Hospital, Ghent at 3 sites in Belgium.
Trial summary
Prospective trial comparing the efficacy and safety of CryoBalloonAblation (CBA) to standardized medication for treatment of early onset persistent atrial fibrillation (AF) without structural heart disease. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- single ablation (CryoBalloonAblation (CBA) and sequential drug adjustment (propafenone, sotalol or flecainide)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 3 sitesBelgium
- Study dates
- 3 Mar 2015to 14 May 2020
- Phase
- Phase 4
- 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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 21 years and legally capable
- First documentation or history of symptomatic AF more than 30 sec within the last 2 years
- Twice AF within the last year
- One episode cardioverted after more than 48 hours or spontaneously terminated after more than 7 days
- Eligible for at least one first step drug therapy (sotalol, propafenone, or flecainide) and for amiodarone
- Left ventricular ejection fraction estimated > 45%
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- LA diameter < 50 mm (parasternal short axis) and LA volume less than 100 ml (apical view, Area Length method;)
- CHADS2 ≤ 2
- Failed AAD strategy, or untreated with AAD
- No use of Amiodarone in the previous 3 months (except IV or oral for 7 days)
- Informed consent
Who cannot join
- Age > 75 yrs
- CHF
- Ischemic heart disease as known in the history
- (Severe) Left ventricular hypertrophy as shown on echo (IVSd or PWd > 14 mm)
- Hyperthyroidism
- Congenital heart disease
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- Hypertrophic Cardiomyopathy, Arrhythmogenic Right ventricular Cardiomyopathy, channelopathies
- Contra-indications to AAD
- Long QT syndrome
- Received already adequately dosed all level 1 drugs (sotalol, propafenone, and flecainide)
- Pure (typical) atrial flutter as documented on one occasion
Trial locations and contacts
3 sites in 1 country.
Belgium3 sites
Brussels Heart Centre
Brussels, 1000
Saint Luc
Brussels
Dept Cardiologie
Ghent, 9000
About this study
Official title: A Prospective Study of Medical Therapy Against Cryoballoon Ablation in Symptomatic Recent Onset Persistent Atrial Fibrilation
Prospective trial comparing the efficacy and safety of CryoBalloonAblation (CBA) to standardized medication for treatment of early onset persistent atrial fibrillation (AF) without structural heart disease. The value of CBA in these patients has never been studied; the endpoints for persistent patients are much easier than for paroxysmal patients. Reduction in left atrial (LA) size will be compared versus patients on drug therapy and versus failing patients.
Read the detailed description
The total AF history should be shorter than 24 months. Symptomatic patients can be included if they have had within the last year at least 2 episodes of documented AF, lasting minimal 30 sec. One episode in the entire history should have lasted more than 48 h, requiring electrical or pharmacological cardioversion or stopped spontaneously after more than 7 days.
All patients eligible for the study will sign informed consent, have an echocardiogram prior to inclusion to exclude severe left ventricular dysfunction, to rule out significant valve abnormalities, left ventricular hypertrophy and to assess the LA volume and diameter.
Prior to randomization, and after inclusion it is suggested to the local investigators to perform an MRI-scan or CT scan of the LA and pulmonary veins (in both branches of the study ) in eligible patients to assess the anatomy and the left atrial volume. The results should not influence the strategy of treatment.
- Conditions
- Atrial Fibrillation
- Being tested
- single ablation (CryoBalloonAblation (CBA), sequential drug adjustment (propafenone, sotalol or flecainide)
- Keywords
- atrial fibrillation, cryoablation, catheter ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single ablation (CryoBalloonAblation (CBA)Device
Cryoablation at entry, after randomization to this group
sequential drug adjustment (propafenone, sotalol or flecainide)Drug
Correct drug dosage at entry, sequential adjustment / titration, in stage 2 amiodarone
| Study group | Role | What they receive |
|---|---|---|
| Cryoablation | Experimental | Cryoballoon single ablation (as described in the reference) at entry after randomization to this group. Single procedure,not to be repeated. Receives: Device: single ablation (CryoBalloonAblation (CBA) |
| Drug | Active comparator | Conventional, available anti arrhythmic drugs (propafenone, sotalol or flecainide), in a first stage, sequential, with amiodarone in second stage Receives: Drug: sequential drug adjustment (propafenone, sotalol or flecainide) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sinus rhythm
Sinus rhythm at one year
Measured: one year
Secondary outcomes (8)
Reduction LA volume
Reduction left atrial volume in successfully treated patients
Measured: one year
Number of cardioversions
Number of cardioversions
Measured: one year
Percentage on anti arrhythmic drugs (AAD)
Percentage on AAD in each group
Measured: 6 months
Percentage on AAD
Percentage on AAD in each group
Measured: 12 months
Vascular complications
Vascular complications, including tamponade
Measured: one year
Stroke, transient ischemic attack (TIA)
Stroke, TIA (symptomatic)
Measured: one year
Serious adverse events (SAE)
Adverse events leading to admission or death
Measured: one year
Freedom of AF
Freedom of atrial fibrillation with all means
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study start3 Mar 2015
- Primary completion14 May 2020
- Study completion14 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luc Jordaens, MD, PhD, Principal investigator, Professor of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02389218
- Sponsor's protocol ID
- 2013/1113
- Acronym
- METACSA
- Status last verified
- Jul 2023
- First submitted
- 9 Mar 2015
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Van Belle Y, Janse P, Theuns D, Szili-Torok T, Jordaens L. One year follow-up after cryoballoon isolation of the pulmonary veins in patients with paroxysmal atrial fibrillation. Europace. 2008 Nov;10(11):1271-6. doi: 10.1093/europace/eun218.
PubMed 18955409
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Medical Therapy Against Cryoballoon Ablation in Symptomatic Recent Onset Persistent Atrial Fibrilation
- ClinicalTrials.gov ID
- NCT02389218
- Acronym / sponsor ID
- METACSA / 2013/1113
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, cryoablation, catheter ablation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 3 Mar 2015 (actual)
- Primary completion
- 14 May 2020 (actual)
- Study completion
- 14 May 2020 (actual)
- First posted
- 17 Mar 2015 (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.
Prospective trial comparing the efficacy and safety of CryoBalloonAblation (CBA) to standardized medication for treatment of early onset persistent atrial fibrillation (AF) without structural heart disease. The value of CBA in these patients has never been studied; the endpoints for persistent patients are much easier than for paroxysmal patients. Reduction in left atrial (LA) size will be compared versus patients on drug therapy and versus failing patients.
Detailed description
The total AF history should be shorter than 24 months. Symptomatic patients can be included if they have had within the last year at least 2 episodes of documented AF, lasting minimal 30 sec. One episode in the entire history should have lasted more than 48 h, requiring electrical or pharmacological cardioversion or stopped spontaneously after more than 7 days.
All patients eligible for the study will sign informed consent, have an echocardiogram prior to inclusion to exclude severe left ventricular dysfunction, to rule out significant valve abnormalities, left ventricular hypertrophy and to assess the LA volume and diameter.
Prior to randomization, and after inclusion it is suggested to the local investigators to perform an MRI-scan or CT scan of the LA and pulmonary veins (in both branches of the study ) in eligible patients to assess the anatomy and the left atrial volume. The results should not influence the strategy of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cryoablation | Experimental | Device: single ablation (CryoBalloonAblation (CBA)Cryoballoon single ablation (as described in the reference) at entry after randomization to this group. Single procedure,not to be repeated. |
| Drug | Active comparator | Drug: sequential drug adjustment (propafenone, sotalol or flecainide)Conventional, available anti arrhythmic drugs (propafenone, sotalol or flecainide), in a first stage, sequential, with amiodarone in second stage |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- > 21 years and legally capable
- First documentation or history of symptomatic AF more than 30 sec within the last 2 years
- Twice AF within the last year
- One episode cardioverted after more than 48 hours or spontaneously terminated after more than 7 days
- Eligible for at least one first step drug therapy (sotalol, propafenone, or flecainide) and for amiodarone
Key exclusion criteria (11 listed)
- Age > 75 yrs
- CHF
- Ischemic heart disease as known in the history
- (Severe) Left ventricular hypertrophy as shown on echo (IVSd or PWd > 14 mm)
- Hyperthyroidism
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 |
|---|---|---|
| single ablation (CryoBalloonAblation (CBA)Cryoablation at entry, after randomization to this group | Device | Cryoablation |
| sequential drug adjustment (propafenone, sotalol or flecainide)Correct drug dosage at entry, sequential adjustment / titration, in stage 2 amiodarone | Drug | Drug |
Primary outcome
Sinus rhythm
Time frame: one year
Sinus rhythm at one year
8 secondary outcomes
Reduction LA volume
Time frame: one year
Number of cardioversions
Time frame: one year
Percentage on anti arrhythmic drugs (AAD)
Time frame: 6 months
Percentage on AAD
Time frame: 12 months
Vascular complications
Time frame: one year
Stroke, transient ischemic attack (TIA)
Time frame: one year
Serious adverse events (SAE)
Time frame: one year
Freedom of AF
Time frame: one year
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 1 Aug 2023.
- Background: PubMed 18955409Van Belle Y, Janse P, Theuns D, Szili-Torok T, Jordaens L. One year follow-up after cryoballoon isolation of the pulmonary veins in patients with paroxysmal atrial fibrillation. Europace. 2008 Nov;10(11):1271-6. doi: 10.1093/europace/eun218.
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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.
Luc Jordaens, MD, PhD principal investigator
Professor of Cardiology
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing single ablation (CryoBalloonAblation (CBA) and sequential drug adjustment (propafenone, sotalol or flecainide) in people with Atrial Fibrillation, run by University Hospital, Ghent at 3 sites in Belgium.
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 11 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 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Sinus rhythm (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02389218, which also lists 1 linked publication.
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 1 Aug 2023.