Atrial FibrillationPOWERAFNCT04122963
CLOSE-guided Pulmonary Vein Isolation Using High Power and Stable RF Applications
A study testing High power CLOSE-guided PVI ablation and Standard CLOSE-guided PVI ablation in people with Atrial Fibrillation, run by AZ Sint-Jan AV at 1 site in Belgium.
Trial summary
In this prospective, randomised, controlled, unblinded,monocentric study, we aim to evaluate the safety and efficacy of higher power CLOSE-guided PVI in patients referred for a first ablation for paroxysmal AF. We aim to include 100 patients into two groups (1:1). 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?
- High power CLOSE-guided PVI ablation and Standard CLOSE-guided PVI ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Feb 2019to 30 Jun 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients referred for symptomatic paroxysmal AF and without advanced structural heart disease
- 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
- Persistent atrial fibrillation (history of AF>7days or history of cardioversion > 48h of AF)
- Previous ablation for AF
- LA antero-posterior diameter>50 mm (parasternal long axis view , PLAX)
- LVEF <35% (ejection fraction)
- AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
- CABG procedure within the last three months
Show all 19Show fewer
- Awaiting cardiac transplantation or other cardiac surgery
- Documented left atrial thrombus on imaging
- Diagnosed atrial myxoma
- Women who are pregnant or breastfeeding
- Acute illness or active systemic infection or sepsis
- Unstable angina
- Uncontrolled heart failure
- Myocardial infarction within the previous two 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CLOSE-guided Pulmonary Vein Isolation Using High Power and Stable RF Applications: a Randomized Study. The POWERAF Study
In this prospective, randomised, controlled, unblinded,monocentric study, we aim to evaluate the safety and efficacy of higher power CLOSE-guided PVI in patients referred for a first ablation for paroxysmal AF. We aim to include 100 patients into two groups (1:1). The experimental group will receive AF ablation with 45 Watt and stricter stability criteria (3 mm for 3 seconds) compared to the control group which will receive AF ablation according to the standard CLOSE-protocol (35 Watt and stability criteria of 3 mm for 8 seconds).
Read the detailed description
BACKGROUND: In a population of paroxysmal AF 'CLOSE'-guided PVI (Target Ablation index (AI) >550 and >400 for anterior and posterior wall respectively, interlesion distance ≤6mm) has been shown to obtain single-procedure durable PV isolation. However, the optimal RF power and stability criteria is unknown.
OBJECTIVES: With this study, we aim at evaluation the efficacy and the safety of higher power (45 watts) and stricter stability criteria (3 mm for 3 sec) as compared to a standard CLOSE protocol (35 watts with stability of 3 mm for 8 sec) in patients referred for a first ablation for paroxysmal AF.
POPULATION: Eligible patients are patients with paroxysmal AF who are planned for a 'CLOSE'-guided PV isolation for paroxysmal AF. At the time of the procedrual planning, we will ask the patient his/her consent for collectio of data. We aim at including 100 patients.
- Conditions
- Atrial Fibrillation
- Being tested
- High power CLOSE-guided PVI ablation, Standard CLOSE-guided PVI 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.
High power CLOSE-guided PVI ablationProcedure or surgery
CLOSE-guided PVI ablation with 45 Watt and stricter stability criteria (3 mm for 3 seconds)
Standard CLOSE-guided PVI ablationProcedure or surgery
Standard AF ablation according to the CLOSE-protocol
| Study group | Role | What they receive |
|---|---|---|
| High power group | Active comparator | The experimental group will receive AF ablation with 45 Watt and stricter stability criteria (3 mm for 3 seconds). Receives: Procedure: High power CLOSE-guided PVI ablation |
| Standard group | Active comparator | The control group will receive AF ablation according to the standard CLOSE-protocol (35 Watt and stability criteria of 3 mm for 8 seconds) Receives: Procedure: Standard CLOSE-guided PVI ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: Acute procedural success
First pass pulmonary vein isolation confirmed after adenosine injection
Measured: At time of ablation
Safety: Absence of clinical complications
Absence of clinical complications during the procedure and up to one month thereafter
Measured: From time of ablation to 1 month post procedure
Secondary outcomes (12)
Procedural duration time
Measured: At time of ablation
Duration for pulmonary vein isolation
Measured: At time of ablation
Fluoroscopic duration and irradiation (AK)
Measured: At time of ablation
Amount of ablation points associated with temperature rise
Measured: At time of ablation
Maximum temperature in case of temperature rise
Measured: At time of ablation
Incidence of adverse events related to ablation
Measured: From time of ablation to 6 months post procedure
First pass encirclement isolation rate
Measured: At time of ablation
Reconnection rate after adenosine
Measured: At time of ablation
Number of dislocations
Measured: At time of ablation
Number of ablation points with an oesophageal temperature rise >39°C
Measured: At time of ablation
Maximum temperature in case of oesophageal temperature rise
Measured: At time of ablation
Longterm procedural success rate
Measured: Six months after ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start15 Feb 2019
- Primary completion25 Sep 2019
- Study completion30 Jun 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.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- AZ Sint-Jan AV
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sebastien Knecht, AZ Sint-Jan AV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04122963
- Sponsor's protocol ID
- 2406
- Acronym
- POWERAF
- Status last verified
- Feb 2021
- First submitted
- 9 Oct 2019
- Last updated
- 12 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wielandts JY, Kyriakopoulou M, Almorad A, Hilfiker G, Strisciuglio T, Phlips T, El Haddad M, Lycke M, Unger P, Le Polain de Waroux JB, Vandekerckhove Y, Tavernier R, Duytschaever M, Knecht S. Prospective Randomized Evaluation of High Power During CLOSE-Guided Pulmonary Vein Isolation: The POWER-AF Study. Circ Arrhythm Electrophysiol. 2021 Jan;14(1):e009112. doi: 10.1161/CIRCEP.120.009112. Epub 2020 Dec 10.
PubMed 33300809
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CLOSE-guided Pulmonary Vein Isolation Using High Power and Stable RF Applications: a Randomized Study. The POWERAF Study
- ClinicalTrials.gov ID
- NCT04122963
- Acronym / sponsor ID
- POWERAF / 2406
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- AZ Sint-Jan AVUniversity, hospital or other
- Study start
- 15 Feb 2019 (actual)
- Primary completion
- 25 Sep 2019 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 10 Oct 2019 (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.
In this prospective, randomised, controlled, unblinded,monocentric study, we aim to evaluate the safety and efficacy of higher power CLOSE-guided PVI in patients referred for a first ablation for paroxysmal AF. We aim to include 100 patients into two groups (1:1). The experimental group will receive AF ablation with 45 Watt and stricter stability criteria (3 mm for 3 seconds) compared to the control group which will receive AF ablation according to the standard CLOSE-protocol (35 Watt and stability criteria of 3 mm for 8 seconds).
Detailed description
BACKGROUND: In a population of paroxysmal AF 'CLOSE'-guided PVI (Target Ablation index (AI) >550 and >400 for anterior and posterior wall respectively, interlesion distance ≤6mm) has been shown to obtain single-procedure durable PV isolation. However, the optimal RF power and stability criteria is unknown.
OBJECTIVES: With this study, we aim at evaluation the efficacy and the safety of higher power (45 watts) and stricter stability criteria (3 mm for 3 sec) as compared to a standard CLOSE protocol (35 watts with stability of 3 mm for 8 sec) in patients referred for a first ablation for paroxysmal AF.
POPULATION: Eligible patients are patients with paroxysmal AF who are planned for a 'CLOSE'-guided PV isolation for paroxysmal AF. At the time of the procedrual planning, we will ask the patient his/her consent for collectio of data. We aim at including 100 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High power group | Active comparator | Procedure: High power CLOSE-guided PVI ablationThe experimental group will receive AF ablation with 45 Watt and stricter stability criteria (3 mm for 3 seconds). |
| Standard group | Active comparator | Procedure: Standard CLOSE-guided PVI ablationThe control group will receive AF ablation according to the standard CLOSE-protocol (35 Watt and stability criteria of 3 mm for 8 seconds) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All patients referred for symptomatic paroxysmal AF and without advanced structural heart disease
- Signed Patient Informed Consent Form
- Age 18 years or older
- Able and willing to comply with all follow-up testing and requirements
Key exclusion criteria (19 listed)
- Persistent atrial fibrillation (history of AF>7days or history of cardioversion > 48h of AF)
- Previous ablation for AF
- LA antero-posterior diameter>50 mm (parasternal long axis view , PLAX)
- LVEF <35% (ejection fraction)
- 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 |
|---|---|---|
| High power CLOSE-guided PVI ablationCLOSE-guided PVI ablation with 45 Watt and stricter stability criteria (3 mm for 3 seconds) | Procedure or surgery | High power group |
| Standard CLOSE-guided PVI ablationStandard AF ablation according to the CLOSE-protocol | Procedure or surgery | Standard group |
Primary outcome
Efficacy: Acute procedural success
Time frame: At time of ablation
First pass pulmonary vein isolation confirmed after adenosine injection
Safety: Absence of clinical complications
Time frame: From time of ablation to 1 month post procedure
Absence of clinical complications during the procedure and up to one month thereafter
12 secondary outcomes
Procedural duration time
Time frame: At time of ablation
Duration for pulmonary vein isolation
Time frame: At time of ablation
Fluoroscopic duration and irradiation (AK)
Time frame: At time of ablation
Amount of ablation points associated with temperature rise
Time frame: At time of ablation
Maximum temperature in case of temperature rise
Time frame: At time of ablation
Incidence of adverse events related to ablation
Time frame: From time of ablation to 6 months post procedure
First pass encirclement isolation rate
Time frame: At time of ablation
Reconnection rate after adenosine
Time frame: At time of ablation
Number of dislocations
Time frame: At time of ablation
Number of ablation points with an oesophageal temperature rise >39°C
Time frame: At time of ablation
Maximum temperature in case of oesophageal temperature rise
Time frame: At time of ablation
Longterm procedural success rate
Time frame: Six months after 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 12 Feb 2021.
- Results publication: PubMed 33300809Wielandts JY, Kyriakopoulou M, Almorad A, Hilfiker G, Strisciuglio T, Phlips T, El Haddad M, Lycke M, Unger P, Le Polain de Waroux JB, Vandekerckhove Y, Tavernier R, Duytschaever M, Knecht S. Prospective Randomized Evaluation of High Power During CLOSE-Guided Pulmonary Vein Isolation: The POWER-AF Study. Circ Arrhythm Electrophysiol. 2021 Jan;14(1):e009112. doi: 10.1161/CIRCEP.120.009112. Epub 2020 Dec 10.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High power CLOSE-guided PVI ablation and Standard CLOSE-guided PVI ablation in people with Atrial Fibrillation, run by AZ Sint-Jan AV at 1 site 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 4 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 12 Feb 2021. 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 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.
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?
Efficacy: Acute procedural success (time frame: At time of ablation). 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?
On the ClinicalTrials.gov record for NCT04122963, 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 12 Feb 2021.