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
Qualifiers
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
Treatments tested in this trial
- Focal Pulse field Ablation
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov