An Exploratory Study of Focal Pulse Ablation System in the Treatment of Atrial Arrhythmia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHangzhou Dinova EP Technology Co., Ltd
About this trial
This is a prospective, single-group clinical study. The objective is to evaluate the safety and efficacy of focal pulse ablation system in the treatment of typical atrial flutter.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects aged at least 18;
Subjects with at least one typical atrial flutter attack recorded by ECG or holter in the 180 days prior to enrollment, and the ECG of other hospitals could be accepted;
Subjects are able to understand the purpose of the study, voluntarily participate in the study and sign the informed consent, and are willing to complete the follow-up according to the requirements of the program.
Disqualifiers
Any prior cavo-tricuspid isthmus ablation;
Unstable angina;
Atrial flutter secondary to electrolyte disorder, thyroid disease or other reversible causes;
Myocardial infarction or coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) within the prior three months;
Trial design
Design model
Single group
Treatments tested in this trial
Focal Pulse field Ablation
DeviceBidirectional block of the cavo-tricuspid isthmus (CTI) was performed with the novel focal pulse field ablation.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Focal pulse ablation systemExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Acute procedural success
Acute procedural success is defined as the creation of bidirectional conduction block across the cavo-tricuspid isthmus immediately and 30 minutes after ablation.
Time frame
immediately after the procedureSecondary outcomes
1
Chronic success
Chronic success is defined as the absence of recurrent atrial flutter at 6 months post-ablation according to electrocardiogram data, including electrocardiogram, 24-hour Holter.
Time frame
6 months after procedure2
Ablation efficiency including total procedure time, catheter dwell time, pulse discharge time and total X-ray exposure time
Total procedure time (defined as the total time from initial femoral venipuncture to final catheter removal), catheter dwell time (time between the pulsed field ablation catheter entering the left atrium and its withdrawal from the left atrium), pulse discharge time (The total time of delivering pulse energy through the pulsed field ablation catheter, single ablation time ablation times), total X-ray exposure time (the total time of X-ray imaging of the catheter)
Time frame
immediately after the procedure3
Incidence of device-related major adverse events (MAE) within 7 days after ablation
Device-related MAE includes death, myocardial infarction, pulmonary embolism, stroke /TIA, severe pericardial effusion, and complete atrioventricular block.
Time frame
within 7 days after ablation4
Incidence of device-related severe adverse events (SAE)
Device-related SAE refers to a device-related event that occurs during the clinical trial that results in mortality or serious deterioration in patient health, including a fatal illness or injury, a permanent defect in body structure or body function, or an event that requires medical or surgical intervention to avoid one or more permanent defects in body structure or body function.
Time frame
3 months and 6 months after procedureSponsors and contacts
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Source ClinicalTrials.gov