First in Man Study of Left Atrial Appendage Pulsed Field Ablation Occluder (NCT05731882) | Clinical Trial Compass
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First in Man Study of Left Atrial Appendage Pulsed Field Ablation Occluder
China10 participantsStarted 2022-07-17
Plain-language summary
This is the first in man study of E-SeaLATM developed and manufactured by Hangzhou Dinova EP Technology Co., Ltd, which can achieve pulsed field ablation and mechanical closure of the Left Atrial Appendage simultaneously, this study aims to initially verify the safety and efficacy of the device.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. The age of the patient is 18\~80 years old;
✓. patients diagnosed with non-valvular atrial fibrillation (at least 1 episode of atrial fibrillation recorded on ECG or Holter in the 12 months prior to enrollment);
✓. CHA2DS2-VASC score: male≥ 2, female≥ 3;
✓. patients are not suitable for long-term oral anticoagulant therapy (any of the following): (1) not suitable for long-term standardized anticoagulation therapy; (2) stroke or embolism still occurs on the basis of long-term standardized anticoagulation therapy; (3) HAS-BLED score≥ 3 points; (4) need to be treated with antiplatelet drugs; (5) unwillingness to undergo long-term anticoagulant therapy;
✓. Be able to understand the purpose of the study, voluntarily participate in the study, sign the informed consent form by the subject himself or her legal representative, and be willing to complete the follow-up in accordance with the requirements of the program.
Exclusion criteria
✕. Atrial fibrillation secondary to electrolyte imbalances, thyroid disease or other reversible factors;
✕. Left atrial appendage depth \< 15mm, left atrial appendage anchor area \< 10mm or \>33mm;
✕. Left atrial diameter≥ 65mm;
✕. Imaging examination shows left atrium or left atrial appendage thrombosis;
✕. Severe structural heart disease (such as moderate to severe aortic valve, mitral stenosis or regurgitation);
What they're measuring
1
Technical success rate
Timeframe: immediately after the procedure
2
The incidence of major adverse events (MAEs) related to devices or procedures 3 months after procedure