Back to resultsAF 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) (CLOSEMAZE)
Primary Purpose
Atrial Fibrillation
Status
Active
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
PVI only
PVI with substrate ablation
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria
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.
Exclusion Criteria
- 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
- 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
Sites / Locations
- AZ Sint-Jan Brugge-Oostende AV
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Pulmonary vein isolation (PVI) only
PVI with substrate
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Atrial tachyarrhythmia burden after one CLOSEMAZE guided ablation
ATA burden after first ablation documented through continuous loop recordings
Atrial tachyarrhythmia burden after two CLOSEMAZE guided ablation
ATA burden after two ablations documented through continuous loop recordings
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04773119
Brief 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)
Acronym
CLOSEMAZE
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 10, 2018 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
AZ Sint-Jan AV
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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). 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pulmonary vein isolation (PVI) only
Arm Type
Active Comparator
Arm Title
PVI with substrate
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
PVI only
Intervention Description
Patients in this group receive PVI only
Intervention Type
Procedure
Intervention Name(s)
PVI with substrate ablation
Intervention Description
Patients in this group receive PVI as well as substrate ablation
Primary Outcome Measure Information:
Title
Atrial tachyarrhythmia (ATA) burden before and after 'CLOSEMAZE'-guided based ablation and off anti-arrhythmic drug (AAD) therapy
Description
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
Time Frame
CLR implant to 3 year post ablation
Secondary Outcome Measure Information:
Title
Atrial tachyarrhythmia burden after one CLOSEMAZE guided ablation
Description
ATA burden after first ablation documented through continuous loop recordings
Time Frame
3 years after ablation
Title
Atrial tachyarrhythmia burden after two CLOSEMAZE guided ablation
Description
ATA burden after two ablations documented through continuous loop recordings
Time Frame
3 years after ablation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
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.
Exclusion Criteria
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sébastien Knecht, MD, PhD
Organizational Affiliation
AZ Sint-Jan AV
Official's Role
Principal Investigator
Facility Information:
Facility Name
AZ Sint-Jan Brugge-Oostende AV
City
Brugge
State/Province
West-Flanders
ZIP/Postal Code
8000
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
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)
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