Status:
COMPLETED
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)
Lead Sponsor:
AZ Sint-Jan AV
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
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 atri...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 29 2024
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT04773119
Start Date
October 10 2018
End Date
July 29 2024
Last Update
April 22 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
AZ Sint-Jan Brugge-Oostende AV
Bruges, West-Flanders, Belgium, 8000