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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Grid X and EnSite X v3.1.1 Software
DeviceThe study procedure will be performed with the investigational Grid X Mapping Catheter, along with the EnSite X EP System with EnSite X v3.1.1 Software for mapping according to the investigational instructions for use documents. The ablation will be performed with the commercially available TactiFlex Ablation Catheter, Sensor Enabled according to the IFU.
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Grid X and EnSite X v3.1.1 SoftwareExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Rate of specified device and/or procedure-related serious adverse events
Safety will be summarized as the rate of subjects experiencing a device and/or procedure-related serious adverse event with onset prior to subject discharge from the hospital after any study procedure that used the Grid X mapping catheter and EnSite X EP System (v3.1.1), as defined below: * Esophageal perforating complications * Cardiac tamponade/perforation * Death * Heart block * Myocardial infarction * Pericarditis * Phrenic nerve injury resulting in diaphragmatic paralysis * Pulmonary edema * Pulmonary vein stenosis * Stroke/cerebrovascular accident * Thromboembolism * Transient ischemic attack * Vagal nerve injury/gastroparesis * Major vascular access complications / major bleeding event * Device and/or procedure related cardiovascular and/or pulmonary adverse event that prolongs hospitalization for more than 48 hours (excluding hospitalization solely for arrhythmia recurrence or non-urgent cardioversion)
Time frame
From the study procedure to subject's discharge from the hospital2
Proportion of subjects with ablation targets identified by HD Grid X catheter
The primary effectiveness endpoint will be defined as the proportion of subjects in which ablation targets were able to be defined or identified by HD mapping using the Grid X catheter. The definitions of ablation targets include, but are not limited to: * Reconnected pulmonary veins * Low voltage zones * Slow conduction sites * Focal arrhythmias * Complex fractionated electrograms * Areas of fibrosis/scar
Time frame
During the study procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov