Atrial FibrillationPhase 4POWER-PLUSNCT04784013
Very High Power Ablation in Patients With Atrial Fibrillation Scheduled for a First Pulmonary Vein Isolation
A Phase 4 study testing Conventional CLOSE-guided pulmonary vein isolation and High power short duration pulmonary vein isolation in people with Atrial Fibrillation, run by AZ Sint-Jan AV at 4 sites in 4 countries.
Trial summary
This prospective, randomized, controlled, unblinded, multicenter study aims at comparing procedural time between conventional CLOSE-guided pulmonary vein isolation (PVI) (35W/50W) versus very high power radiofrequency delivery (90W) in atrial fibrillation patients scheduled for a first PVI. 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?
- Conventional CLOSE-guided pulmonary vein isolation and High power short duration pulmonary vein isolation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 24 Mar 2021to 31 May 2022
- 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
- Patients older than 18 years
- Patients scheduled for a first PVI only for paroxysmal atrial fibrillation (AF) (self-terminating or <7days) or persistent AF (persistent AF is defined as having an AF episode >7d); (patients with paroxysmal AF or short-standing persistent AF presenting with flutter, who are in need of a cavotricuspid isthmus ablation, are allowed to participate in this trial)
- Patients willing to sign informed consent
Who cannot join
- Patients with long-standing persistent AF (long-standing persistent AF is defined as having an AF episode >1yr)
- Previous ablation for AF
- Left atrium antero-posterior diameter >50 mm (parasternal long axis view, PLAX)
- AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
- Left atrial appendage (LAA) thrombus. LAA thrombus can be determined by preprocedural imaging: CT, transesophageal echocardiography or MRI.
- Left ventricular ejection fraction <35%.
Show all 22Show fewer
- Cardiac surgery within the previous 90 days.
- Expecting cardiac transplantation or other cardiac surgery within 180 days.
- Coronary percutaneous transluminal coronary angioplasty/stenting within the previous 90 days or myocardial infarction within the previous 60 days.
- Documented history of a thromboembolic event within the previous 90 days.
- Diagnosed atrial myxoma.
- Significant restrictive, constrictive, or chronic obstructive pulmonary disease with chronic symptoms.
- Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment
- Women who are pregnant or who plan to become pregnant during the study.
- Acute illness or active infection at time of index procedure
- Advanced renal insufficiency
- Unstable angina.
- History of blood clotting or bleeding abnormalities.
- Contraindication to anticoagulation.
- Life expectancy less than 1 year.
- Presence of a condition that precludes vascular access.
- Unwilling or unable to provide informed consent.
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
Official title: Very High Power Ablation in Patients With Atrial Fibrillation Scheduled for a First Pulmonary Vein Isolation: the POWER-PLUS Study
This prospective, randomized, controlled, unblinded, multicenter study aims at comparing procedural time between conventional CLOSE-guided pulmonary vein isolation (PVI) (35W/50W) versus very high power radiofrequency delivery (90W) in atrial fibrillation patients scheduled for a first PVI.
- Conditions
- Atrial Fibrillation
- Being tested
- Conventional CLOSE-guided pulmonary vein isolation, High power short duration pulmonary vein isolation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional CLOSE-guided pulmonary vein isolationProcedure or surgery
Point-by-point RF delivery will be performed aiming for a contiguous circle enclosing the veins. RF will be delivered in a temperature and flow-controlled mode (QMODE, target temperature 45°C, low flow temperature 40°C, cut-off temperature 50°C) with a power of 35W(posterior)/50W(anterior) (irrigation flow at 4-15ml/min). RF will be delivered until an ablation index (AI) of ≥400 at the posterior wall/roof/south pole and ≥550 at the anterior wall.
High power short duration pulmonary vein isolationProcedure or surgery
Point-by-point RF delivery will be performed aiming for a contiguous circle enclosing the veins. RF will be delivered in temperature-controlled mode (QMode+, target temperature 55°C, cut-off temperature 65°C) with a power of 90W (irrigation flow at 2-8ml/min). RF will be delivered for 4 sec at both the posterior and anterior wall.
| Study group | Role | What they receive |
|---|---|---|
| Conventional group | Active comparator | Not described Receives: Procedure: Conventional CLOSE-guided pulmonary vein isolation |
| 90W-group | Active comparator | Not described Receives: Procedure: High power short duration pulmonary vein isolation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural time
Comparison of the procedural time (in minutes) between groups
Measured: Procedure (At time of ablation)
Secondary outcomes (4)
Single procedure atrial tachyarrhythmia freedom between months 4, 5 and 6 after the index ablation
Atrial tachyarrhythmia will be monitored by Holter
Measured: Months 4-6 after ablation
Radiofrequency (RF) ablation time
Comparison of the RF ablation time (in seconds) between groups
Measured: Procedure (At time of ablation)
Fluoroscopy dose
Comparison of the fluoroscopy dose (Gy cm²) between groups
Measured: Procedure (At time of ablation)
First pass isolation rate
Reconnection of the veins after adenosine injection or waiting time
Measured: Procedure (At time of ablation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start24 Mar 2021
- Primary completion22 Oct 2021
- Study completion31 May 2022
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.
- 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
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- AZ Sint-Jan AV
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Mattias Duytschaever, AZ Sint-Jan AV
- Investigators
- Mattias Duytschaever, MD, PhD, Principal investigator, AZ Sint-Jan AV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04784013
- Sponsor's protocol ID
- 2800
- Acronym
- POWER-PLUS
- Status last verified
- Jun 2022
- First submitted
- 3 Mar 2021
- Last updated
- 21 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
O'Neill L, El Haddad M, Berte B, Kobza R, Hilfiker G, Scherr D, Manninger M, Wijnmaalen AP, Trines SA, Wielandts JY, Gillis K, Lycke M, De Becker B, Tavernier R, Le Polain De Waroux JB, Knecht S, Duytschaever M. Very High-Power Ablation for Contiguous Pulmonary Vein Isolation: Results From the Randomized POWER PLUS Trial. JACC Clin Electrophysiol. 2023 Apr;9(4):511-522. doi: 10.1016/j.jacep.2022.10.039. Epub 2023 Jan 18.
PubMed 36752467
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Very High Power Ablation in Patients With Atrial Fibrillation Scheduled for a First Pulmonary Vein Isolation: the POWER-PLUS Study
- ClinicalTrials.gov ID
- NCT04784013
- Acronym / sponsor ID
- POWER-PLUS / 2800
- Conditions
- Atrial Fibrillation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- AZ Sint-Jan AVUniversity, hospital or other
- Study start
- 24 Mar 2021 (actual)
- Primary completion
- 22 Oct 2021 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 5 Mar 2021 (actual)
- 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.
This prospective, randomized, controlled, unblinded, multicenter study aims at comparing procedural time between conventional CLOSE-guided pulmonary vein isolation (PVI) (35W/50W) versus very high power radiofrequency delivery (90W) in atrial fibrillation patients scheduled for a first PVI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional group | Active comparator | Procedure: Conventional CLOSE-guided pulmonary vein isolation |
| 90W-group | Active comparator | Procedure: High power short duration pulmonary vein isolation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients older than 18 years
- Patients scheduled for a first PVI only for paroxysmal atrial fibrillation (AF) (self-terminating or <7days) or persistent AF (persistent AF is defined as having an AF episode >7d); (patients with paroxysmal AF or short-standing persistent AF presenting with flutter, who are in need of a cavotricuspid isthmus ablation, are allowed to participate in this trial)
- Patients willing to sign informed consent
Key exclusion criteria (22 listed)
- Patients with long-standing persistent AF (long-standing persistent AF is defined as having an AF episode >1yr)
- Previous ablation for AF
- Left atrium antero-posterior diameter >50 mm (parasternal long axis view, PLAX)
- AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
- Left atrial appendage (LAA) thrombus. LAA thrombus can be determined by preprocedural imaging: CT, transesophageal echocardiography or MRI.
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 |
|---|---|---|
| Conventional CLOSE-guided pulmonary vein isolationPoint-by-point RF delivery will be performed aiming for a contiguous circle enclosing the veins. RF will be delivered in a temperature and flow-controlled mode (QMODE, target temperature 45°C, low flow temperature 40°C, cut-off temperature 50°C) with a power of 35W(posterior)/50W(anterior) (irrigation flow at 4-15ml/min). RF will be delivered until an ablation index (AI) of ≥400 at the posterior wall/roof/south pole and ≥550 at the anterior wall. | Procedure or surgery | Conventional group |
| High power short duration pulmonary vein isolationPoint-by-point RF delivery will be performed aiming for a contiguous circle enclosing the veins. RF will be delivered in temperature-controlled mode (QMode+, target temperature 55°C, cut-off temperature 65°C) with a power of 90W (irrigation flow at 2-8ml/min). RF will be delivered for 4 sec at both the posterior and anterior wall. | Procedure or surgery | 90W-group |
Primary outcome
Procedural time
Time frame: Procedure (At time of ablation)
Comparison of the procedural time (in minutes) between groups
4 secondary outcomes
Single procedure atrial tachyarrhythmia freedom between months 4, 5 and 6 after the index ablation
Time frame: Months 4-6 after ablation
Radiofrequency (RF) ablation time
Time frame: Procedure (At time of ablation)
Fluoroscopy dose
Time frame: Procedure (At time of ablation)
First pass isolation rate
Time frame: Procedure (At time of ablation)
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 21 Jun 2022.
- Derived from this study: PubMed 36752467O'Neill L, El Haddad M, Berte B, Kobza R, Hilfiker G, Scherr D, Manninger M, Wijnmaalen AP, Trines SA, Wielandts JY, Gillis K, Lycke M, De Becker B, Tavernier R, Le Polain De Waroux JB, Knecht S, Duytschaever M. Very High-Power Ablation for Contiguous Pulmonary Vein Isolation: Results From the Randomized POWER PLUS Trial. JACC Clin Electrophysiol. 2023 Apr;9(4):511-522. doi: 10.1016/j.jacep.2022.10.039. Epub 2023 Jan 18.
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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.
Mattias Duytschaever, MD, PhD principal investigator
AZ Sint-Jan AV
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Conventional CLOSE-guided pulmonary vein isolation and High power short duration pulmonary vein isolation in people with Atrial Fibrillation, run by AZ Sint-Jan AV at 4 sites in 4 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 3 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: finished, as of the sponsor's last update on 21 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Austria, Belgium, Netherlands, Switzerland. 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?
Procedural time (time frame: Procedure (At time of ablation)). 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 NCT04784013, 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 21 Jun 2022.