Atrial FibrillationCLOSEMAZENCT04773119
AF Burden and Echo-guided Persistent AF Ablation Strategy Using Either PV Isolation Alone (CLOSE Protocol) or Optimized Compartmentalization of the Left Atrium (Pseudo-maze Technique)
A study testing PVI only and PVI with substrate ablation in people with Atrial Fibrillation, run by AZ Sint-Jan AV at 1 site in Belgium.
Trial summary
Recent publications suggest that neither empirical nor individualized substrate modification strategies could improve single-procedure efficacy beyond pulmonary vein (PV) isolation for persistent atrial fibrillation (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 only and PVI with substrate ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteBelgium
- Study dates
- 10 Oct 2018to 29 Jul 2024
- 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
- Patients with symptomatic persistent AF (history of continuous AF > 7 days), meeting following criteria at the out-patient clinic:
- patient has AF at the time of the visit
- AF episodes are symptomatic, and patient is drug-resistant (at least one class Ic or III), or drug-intolerant (palpitations, fatigue, dyspnea, cardiomyopathy,…)
- If the patient has heart failure (LVEF<50%), first line AF ablation (instead of amiodarone) is indicated
- 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 (Suspected continuous AF>1 year)
- Previous ablation for AF
- left atrial antero-posterior diameter > 55 mm (parasternal long axis view (PLAX))
- LVEF < 30% (ejection fraction)
- AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
- Coronary artery bypass graft 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: AF Burden and Echo-guided Persistent AF Ablation Strategy Using Either PV Isolation Alone (CLOSE Protocol) or Optimized Compartmentalization of the Left Atrium (Pseudo-maze Technique): the CLOSEMAZE Study
Recent publications suggest that neither empirical nor individualized substrate modification strategies could improve single-procedure efficacy beyond pulmonary vein (PV) isolation for persistent atrial fibrillation (AF). However, persistent AF represent a broad spectrum of the same disease and if PV isolation may be sufficient for some patient with self-terminated AF or with a small left atrium, a more extended substrate ablation may be required for other patients, for which a second procedure for atrial tachycardia (AT) recurrence is then frequently needed. In addition, a lot of progress has recently been made in the field of ablation techniques using contiguous and optimized ablation radiofrequency (RF) lesions and also for AT mapping with promising results using repetitive but discontinuous Holter monitoring.
This trial aims at
- To objectively compare atrial tachyarrhythmia (ATA) burden > 2 months before ablation and after one or two 'CLOSEMAZE'-guided ablation(s) using continuous monitoring and echo data as a guide for the ablation strategy during the first ablation.
- To assess ATA burden using continuous monitoring up to 3 years after ablation.
- To identify baseline structural and electrical properties of the atria or procedural characteristics that predict 1-year and 3-year outcome.
- Conditions
- Atrial Fibrillation
- Being tested
- PVI only, PVI with substrate 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.
PVI onlyProcedure or surgery
Patients in this group receive PVI only
PVI with substrate ablationProcedure or surgery
Patients in this group receive PVI as well as substrate ablation
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary vein isolation (PVI) only | Active comparator | Not described Receives: Procedure: PVI only |
| PVI with substrate | Active comparator | Not described Receives: Procedure: PVI with substrate ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial tachyarrhythmia (ATA) burden before and after 'CLOSEMAZE'-guided based ablation and off anti-arrhythmic drug (AAD) therapy
ATA burden (= time that a subject experiences AF) will be monitored with continuous loop recording (CLR) from time of CLR implant until 3 years after ablation
Measured: CLR implant to 3 year post ablation
Secondary outcomes (2)
Atrial tachyarrhythmia burden after one CLOSEMAZE guided ablation
ATA burden after first ablation documented through continuous loop recordings
Measured: 3 years after ablation
Atrial tachyarrhythmia burden after two CLOSEMAZE guided ablation
ATA burden after two ablations documented through continuous loop recordings
Measured: 3 years after ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start10 Oct 2018
- Primary completion29 Jul 2024
- Study completion29 Jul 2024
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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 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
- Investigators
- Sébastien Knecht, MD, PhD, Principal investigator, AZ Sint-Jan AV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04773119
- Sponsor's protocol ID
- 2312
- Acronym
- CLOSEMAZE
- Status last verified
- Apr 2025
- First submitted
- 10 Feb 2021
- Last updated
- 22 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AF Burden and Echo-guided Persistent AF Ablation Strategy Using Either PV Isolation Alone (CLOSE Protocol) or Optimized Compartmentalization of the Left Atrium (Pseudo-maze Technique): the CLOSEMAZE Study
- ClinicalTrials.gov ID
- NCT04773119
- Acronym / sponsor ID
- CLOSEMAZE / 2312
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- AZ Sint-Jan AVUniversity, hospital or other
- Study start
- 10 Oct 2018 (actual)
- Primary completion
- 29 Jul 2024 (actual)
- Study completion
- 29 Jul 2024 (actual)
- First posted
- 26 Feb 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.
Recent publications suggest that neither empirical nor individualized substrate modification strategies could improve single-procedure efficacy beyond pulmonary vein (PV) isolation for persistent atrial fibrillation (AF). However, persistent AF represent a broad spectrum of the same disease and if PV isolation may be sufficient for some patient with self-terminated AF or with a small left atrium, a more extended substrate ablation may be required for other patients, for which a second procedure for atrial tachycardia (AT) recurrence is then frequently needed. In addition, a lot of progress has recently been made in the field of ablation techniques using contiguous and optimized ablation radiofrequency (RF) lesions and also for AT mapping with promising results using repetitive but discontinuous Holter monitoring.
This trial aims at
- To objectively compare atrial tachyarrhythmia (ATA) burden > 2 months before ablation and after one or two 'CLOSEMAZE'-guided ablation(s) using continuous monitoring and echo data as a guide for the ablation strategy during the first ablation.
- To assess ATA burden using continuous monitoring up to 3 years after ablation.
- To identify baseline structural and electrical properties of the atria or procedural characteristics that predict 1-year and 3-year outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulmonary vein isolation (PVI) only | Active comparator | Procedure: PVI only |
| PVI with substrate | Active comparator | Procedure: PVI with substrate ablation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with symptomatic persistent AF (history of continuous AF > 7 days), meeting following criteria at the out-patient clinic:
- 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)
- Longstanding persistent atrial fibrillation (Suspected continuous AF>1 year)
- Previous ablation for AF
- left atrial antero-posterior diameter > 55 mm (parasternal long axis view (PLAX))
- LVEF < 30% (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 |
|---|---|---|
| PVI onlyPatients in this group receive PVI only | Procedure or surgery | Pulmonary vein isolation (PVI) only |
| PVI with substrate ablationPatients in this group receive PVI as well as substrate ablation | Procedure or surgery | PVI with substrate |
Primary outcome
Atrial tachyarrhythmia (ATA) burden before and after 'CLOSEMAZE'-guided based ablation and off anti-arrhythmic drug (AAD) therapy
Time frame: CLR implant to 3 year post ablation
ATA burden (= time that a subject experiences AF) will be monitored with continuous loop recording (CLR) from time of CLR implant until 3 years after ablation
2 secondary outcomes
Atrial tachyarrhythmia burden after one CLOSEMAZE guided ablation
Time frame: 3 years after ablation
Atrial tachyarrhythmia burden after two CLOSEMAZE guided ablation
Time frame: 3 years 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 22 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
Active, not recruiting
A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF
Atrial Fibrillation
Recruiting
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
Not yet recruitingPhase 4
Sacubitril/Valsartan vs Standard Treatment for Preventing Atrial Fibrillation Recurrence After Catheter Ablation in Persistent Atrial Fibrillation Patients With Without Hypertension
Atrial Fibrillation (Persistent), Catheter Ablation
RecruitingObservational study
A Study of Varipulse Catheter in Participants With Paroxysmal Atrial Fibrillation Under Optimized Sedation
Atrial Fibrillation
RecruitingPhase 3
Thrombolysis in Factor Xa-inhibitors Trial
Stroke, Stroke (in Patients With Atrial Fibrillation)
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.
Sébastien Knecht, MD, PhD principal investigator
AZ Sint-Jan AV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PVI only and PVI with substrate 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 7 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 22 Apr 2025. 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?
Atrial tachyarrhythmia (ATA) burden before and after 'CLOSEMAZE'-guided based ablation and off anti-arrhythmic drug (AAD) therapy (time frame: CLR implant to 3 year post ablation). 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 22 Apr 2025.