Persistent Atrial Fibrillation Clinical Trial
— ELECTROAFOfficial title:
Electroporation for Treatment of Persistent and Longstanding Persistent Atrial Fibrillation
Verified date | December 2023 |
Source | University Medical Centre Ljubljana |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Comparison of pulmonary vein and left atrial posterior wall isolation durability and clinical outcome between radiofrequency and pulse field ablation in patients with persistent and longstanding persistent atrial fibrillation.
Status | Enrolling by invitation |
Enrollment | 50 |
Est. completion date | May 1, 2025 |
Est. primary completion date | December 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - atrial fibrillation recorded with 12-lead ECG, holter ECG or implantable device on two occasions at least one week apart Exclusion Criteria: - history of previous catheter ablation, history of previous heart surgery, life expectancy less than one year, any lifethreatening severe acute condition, acute deep venous thrombosis, presence of intracardiac masses or thrombi. |
Country | Name | City | State |
---|---|---|---|
Slovenia | Cardiovascular Surgery Department, University Medical Centre Ljubljana | Ljubljana |
Lead Sponsor | Collaborator |
---|---|
University Medical Centre Ljubljana |
Slovenia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Durability of isolation | Testing for durability of pulmonary vein and left atrial posterior wall isolation in both study arms with high density endocardial remapping.
Absence of electrical activity or voltage inside ablation lines of less than 0.05 mV or presence of exit block upon pacing with local capture will be considered as proof of pulmonary vein and posterior left atrial wall isolation. |
3 months | |
Secondary | Freedom from atrial arrhythmias | Freedom from atrial tachycardia, atrial flutter and atrial fibrillation during the follow up as assessed with 12-lead ECG and 1-7 day holter ECG recordings at 3, 6, 12 months. With holter recordings any arrhythmia lasting at least 30 seconds will be considered as a recurrence. | 12 months | |
Secondary | Intracardiac electrograms analysis | Five minute recording of bipolar and unipolar intracardiac electrograms with a high density mapping catheter at predetermined locations in pulmonary vein antra and left atrial posterior wall before and after radiofrequency and pulse field ablation at the index procedure. Offline analysis of recorded signals and correlation of immediate changes with persistence of durable lesions (isolation) or conduction gaps. | 1 day | |
Secondary | Recording of complications | Postprocedural endoscopy of the esophagus and endoscopic ultrasound of the esophagus up to 72 hours after the procedure for detection of esophageal injury. Recording of any intra and postprocedural complications up to a 30 day period. | 30 days |
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