FARAPULSE™ Pulsed Field Ablation System
ConditionParoxysmal AF
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBoston Scientific Corporation
About this trial
To obtain real world data on the use of, and provide continued evidence on safety and effectiveness of the FARAPULSE™ Pulsed Field Ablation (PFA) system when used per hospitals' standard of care in Chinese population.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects intended to be treated with the FARAPULSE™ Pulsed Field Ablation system for cardiac tissue ablation, per physician's medical judgement, and as per hospitals' standard of care
Subjects who are willing and capable of providing informed consent
Subjects who are willing and capable of participating in all testing associated with this clinical study at an approved clinical investigational center
Subjects whose age is 18 years or above.
Disqualifiers
Subjects with a current interatrial baffle or patch
Subjects with a known or suspected atrial myxoma
Subjects with a myocardial infarction within 14 days prior to enrollment
Subjects with a recent (within 30 days prior to enrollment) Cerebral Vascular Accident (CVA)
Trial population
Subjects enrolled in the FARADISE study will be clinically indicated for an ablation procedure with the FARAPULSE™ Pulsed Field Ablation system, per indication approved in China, per physician's medical judgement, and according to hospitals' standard of care
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
FARAPULSE™ Pulsed Field Ablation system
Deviceno intervention design in the study
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Failure-free rate
Failure-free rate at 12 Month post index procedure.
Time frame
12 Months2
Device-or procedure-related SAEs:
Composite of the following device- or procedure-related SAEs:
Time frame
7 days and 12 months3
Procedure- and device related adverse events
All FARAPULSE™ PFA procedure- and device related adverse events at 12 Month, 2 Year and 3 Year follow-up.
Time frame
12 Months and 2 years and 3 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov