Atrial FibrillationPhase 4POWDER-AFNCT02475642
Pulmonary Vein Isolation With Versus Without Continued Antiarrhythmic Drug Treatment in Subjects With Recurrent Atrial Fibrillation
A Phase 4 study testing PVI-ADT and PVI+ADT in people with Atrial Fibrillation, run by VZW Cardiovascular Research Center Aalst at 2 sites in Belgium.
Trial summary
The purpose of this study is to compare the efficacy and safety of PV isolation with continued antiarrhythmic drug treatment (PVI+ADT) to PV isolation without continued ADT (PVI-ADT) in patients undergoing treatment for symptomatic recurrent AF. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- PVI-ADT and PVI+ADT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 2 sitesBelgium
- Study dates
- Mar 2014to Aug 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient has continued (IC or III) ADT throughout the 3-month blanking
- patient is free of symptomatic and asymptomatic AF (as evidenced by 1-day Holter) at the 3-month visit
- drug-resistant (at least one class IC or III) symptomatic AF was the primary indication for prior PV isolation
- in the three months prior to PVI, at least one episode of symptomatic or asymptomatic AF
- PV isolation was performed according to the standards set forward by the Task Force Document (sedation or general anesthesia)
- PV isolation was the only target for ablation (except for cavotricuspid (CTI) ablation if documented AFL)
Show all 11Show fewer
- PV isolation was performed by point-by-point irrigated radio frequency (RF) guided by contact-force (Biosense) (10-30gr-continuous lesion)
- PV isolation (i.e. entry block) was verified in each vein after a waiting time and adenosine (with continued RF if acute reconnection)
- Signed Patient Informed Consent Form.
- Age 18 years or older.
- Able and willing to comply with all follow-up testing and requirements.
Who cannot join
- Longstanding persistent atrial fibrillation (>12 months of continuous AF)
- Previous ablation for AF
- left atrium (LA) size > 55 mm
- left ventricular ejection fraction (LVEF) < 40%
- AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
- coronary artery bypass graft (CABG) procedure within the last six months
Show all 22Show fewer
- Awaiting cardiac transplantation or other cardiac surgery
- Documented left atrial thrombus on imaging
- Diagnosed atrial myxoma
- Women who are pregnant (by history of menstrual period or pregnancy test if the history is considered unreliable) or breastfeeding
- Acute illness or active systemic infection or sepsis
- Unstable angina
- Uncontrolled heart failure
- Myocardial infarction within the previous two (2) months
- History of blood clotting or bleeding abnormalities
- Contraindication to anticoagulation therapy (ie, heparin or warfarin)
- Life expectancy less than 12 months
- Enrollment in any other study evaluating another device or drug
- Presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction
- Patients not taking any class IC or III ADT at 3 months after PV isolation
- No documentation of entry block at initial PV isolation - no waiting time or adenosine.
- Additional linear ablation or defractionation during the initial procedure (except for CTI ablation for documented or induced cavo-tricuspid isthmus dependent flutter).
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Pulmonary Vein Isolation With Versus Without Continued Antiarrhythmic Drug Treatment in Subjects With Recurrent Atrial Fibrillation: A Prospective 2-Centre Randomized Controlled Clinical Study (POWDER-AF)
The purpose of this study is to compare the efficacy and safety of PV isolation with continued antiarrhythmic drug treatment (PVI+ADT) to PV isolation without continued ADT (PVI-ADT) in patients undergoing treatment for symptomatic recurrent AF.
Read the detailed description
Subjects that underwent PV isolation for paroxysmal or non-longstanding persistent AF and are free of arrhythmia at the end of the 3-month blanking period while taking ADT. Eligible subjects who sign the study informed consent form will be randomized into one of two study arms:
PVI+ADT Group: continue ADT through 9 months follow-up PVI-ADT Group: no ADT through 9 months follow up
- Conditions
- Atrial Fibrillation
- Being tested
- PVI-ADT, PVI+ADT
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PVI-ADTOther
Discontinue antiarrhythmic drugs at randomisation (3 months post ablation). As per the eligibility criteria, all patients randomised are taking either Flecainide, Cibenzoline, Propafenon, Sotalol or Amiodarone. These are discontinued at the moment of randomisation in this arm
PVI+ADTOther
Discontinue antiarrhythmic drugs 9 months after randomisation (12 months post ablation). As per the eligibility criteria, all patients randomised are taking either Flecainide, Cibenzoline, Propafenon, Sotalol or Amiodarone. These are continued in this arm until 9 months post randomisation at which point they are stopped
| Study group | Role | What they receive |
|---|---|---|
| PVI-ADT | Active comparator | discontinue antiarrhythmic drugs at 3 months post PVI Receives: Other: PVI-ADT |
| PVI+ADT | Active comparator | discontinue antiarrhythmic drugs at 12 months post PVI Receives: Other: PVI+ADT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy as measured by freedom of arrhythmia recurrence
Arrhythmia recurrence rate at 1 year post ablation (9 months post randomization)
Measured: 9 months
Safety as measured by drug discontinuation
Number of participants with any adverse events at 1 year post ablation (9 months post randomization) leading to drug discontinuation
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2015 (estimated)
- Study startMar 2014
- Primary completionAug 2016 (estimated)
- Study completionAug 2016 (estimated)
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- VZW Cardiovascular Research Center Aalst
- Sponsor type
- University, hospital or other
- Collaborators
- AZ Sint-Jan AV
- Responsible party
- Sponsor
- Investigators
- Mattias Duytschaever, MD, PhD, Principal investigator, AZ Sint-Lucas Brugge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02475642
- Sponsor's protocol ID
- POWDER-AF01
- Acronym
- POWDER-AF
- Status last verified
- Apr 2016
- First submitted
- 3 Jun 2015
- Last updated
- 28 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Vein Isolation With Versus Without Continued Antiarrhythmic Drug Treatment in Subjects With Recurrent Atrial Fibrillation: A Prospective 2-Centre Randomized Controlled Clinical Study (POWDER-AF)
- ClinicalTrials.gov ID
- NCT02475642
- Acronym / sponsor ID
- POWDER-AF / POWDER-AF01
- Conditions
- Atrial Fibrillation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 152 participants (actual)
- Lead sponsor
- VZW Cardiovascular Research Center AalstUniversity, hospital or other
- Collaborators
- AZ Sint-Jan AV
- Study start
- Mar 2014
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 19 Jun 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.
The purpose of this study is to compare the efficacy and safety of PV isolation with continued antiarrhythmic drug treatment (PVI+ADT) to PV isolation without continued ADT (PVI-ADT) in patients undergoing treatment for symptomatic recurrent AF.
Detailed description
Subjects that underwent PV isolation for paroxysmal or non-longstanding persistent AF and are free of arrhythmia at the end of the 3-month blanking period while taking ADT. Eligible subjects who sign the study informed consent form will be randomized into one of two study arms:
PVI+ADT Group: continue ADT through 9 months follow-up PVI-ADT Group: no ADT through 9 months follow up
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PVI-ADT | Active comparator | Other: PVI-ADTdiscontinue antiarrhythmic drugs at 3 months post PVI |
| PVI+ADT | Active comparator | Other: PVI+ADTdiscontinue antiarrhythmic drugs at 12 months post PVI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- patient has continued (IC or III) ADT throughout the 3-month blanking
- patient is free of symptomatic and asymptomatic AF (as evidenced by 1-day Holter) at the 3-month visit
- drug-resistant (at least one class IC or III) symptomatic AF was the primary indication for prior PV isolation
- in the three months prior to PVI, at least one episode of symptomatic or asymptomatic AF
- PV isolation was performed according to the standards set forward by the Task Force Document (sedation or general anesthesia)
Key exclusion criteria (22 listed)
- Longstanding persistent atrial fibrillation (>12 months of continuous AF)
- Previous ablation for AF
- left atrium (LA) size > 55 mm
- left ventricular ejection fraction (LVEF) < 40%
- AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
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 |
|---|---|---|
| PVI-ADTDiscontinue antiarrhythmic drugs at randomisation (3 months post ablation). As per the eligibility criteria, all patients randomised are taking either Flecainide, Cibenzoline, Propafenon, Sotalol or Amiodarone. These are discontinued at the moment of randomisation in this arm | Other | PVI-ADT |
| PVI+ADTDiscontinue antiarrhythmic drugs 9 months after randomisation (12 months post ablation). As per the eligibility criteria, all patients randomised are taking either Flecainide, Cibenzoline, Propafenon, Sotalol or Amiodarone. These are continued in this arm until 9 months post randomisation at which point they are stopped | Other | PVI+ADT |
Primary outcome
Efficacy as measured by freedom of arrhythmia recurrence
Time frame: 9 months
Arrhythmia recurrence rate at 1 year post ablation (9 months post randomization)
Safety as measured by drug discontinuation
Time frame: 9 months
Number of participants with any adverse events at 1 year post ablation (9 months post randomization) leading to drug discontinuation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2016.
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
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.
Mattias Duytschaever, MD, PhD principal investigator
AZ Sint-Lucas Brugge
2 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 PVI-ADT and PVI+ADT in people with Atrial Fibrillation, run by VZW Cardiovascular Research Center Aalst at 2 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 22 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 28 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Results are not available in the source record.
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?
Efficacy as measured by freedom of arrhythmia recurrence (time frame: 9 months). The study lists 2 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 28 Apr 2016.