Grid eXplore Mapping Study
ConditionParoxysmal Atrial Fibrillation (PAF)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAbbott Medical Devices
About this trial
The purpose of the trial is to find out if the Grid X Mapping Catheter and EnSite X EP System with EnSite X Software v3.1.1, the devices that are being studied, are safe and effective in treating Chinese patients who have atrial fibrillation.
Participants will receive a procedure called catheter mapping and ablation to treat their abnormal heart rhythms and are required to complete 4 follow-up visits at 7 days, 3 months, 6 months and 12 months after the procedure for checkups and tests.
Eligibility criteria
Qualifiers
Subject must provide written informed consent prior to any clinical investigation-related procedure.
Subject is at least 18 years of age.
Physician's note indicating self-terminating AF AND
Electrocardiographically documented AF NOTE: Documented evidence of the AF episode must either be continuous AF on a 12-lead ECG or include at least 30 seconds of AF from another ECG device.
Disqualifiers
Primary diagnosis or indication for treatment of persistent or long-standing persistent atrial fibrillation (Continuous AF greater than 1 year in duration)
Known presence of cardiac thrombus.
Known existing circumferential pericardial effusion >2 mm prior to catheter insertion.
Presence of any condition that precludes appropriate vascular access
Trial design
Treatments tested in this trial
- Grid X and EnSite X v3.1.1 Software
Treatment groups
200 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov