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 groupLocations
5Qilu Hospital of Shandong University JinanShandong, China
West China Hospital of Sichuan University ChengduSichuan, China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine HangzhouZhejiang, China
The First Affiliated Hospital of Ningbo University NingboZhejiang, China
Sponsors and collaborators
Abbott Medical Devices
Lead sponsor
Source ClinicalTrials.gov