Catheter Ablation Using a Novel Navigation and Imaging System
ConditionParoxysmal Atrial Fibrillation
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLUMA Vision Ltd.
About this trial
The objective of the ENVIsIoN study is to collect data on the use of the VERAFEYE navigation and imaging system in patients indicated to undergo a catheter ablation procedure for the treatment of Paroxysmal Atrial Fibrillation (PAF).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subject is 18 years of age at the time of consent, or of legal age to give informed consent specific to state and national law
Subjects is eligible for a catheter ablation procedure with the VERAFEYE System as navigation and imaging system in the treatment of PAF (according to VERAFEYE System IFUs, current international and local guidelines and per physician discretion)
Subject is able to understand and willing to provide written informed consent
Subject is able to and willing to complete all study assessments associated with this clinical study at an approved clinical investigational center
Disqualifiers
None
Trial population
* Subjects who have undergone a previous cardiac ablation for the treatment of PAF * Subject where placement of VERAFEYE Imaging Catheter is technically not feasible per physician discretion * Pregnant women or women who plan to become pregnant during the course of their participation in the study (women should either be of non- childbearing potential at the time of enrolment (as documented in the medical file) or have a negative pregnancy test within the previous 7 days prior to the procedure) * Unrecovered/unresolved Adverse Events from any previous invasive procedure * Subjects who are currently enrolled in another study (except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments)
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
VERAFEYE System
DeviceVERAFEYE system guidance will be used on all patients undergoing PAF ablation.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Acute procedural success rates during the index procedure
A procedure will be defined as successful if all the following conditions occur during the case: * ability to create a 3D anatomical model with the VERAFEYE System and * completion of the necessary ablation applications for PAF using the 3D anatomical model created with the VERAFEYE System
Time frame
During the procedureLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: