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| ID | Type | Description | Link |
|---|---|---|---|
| CRD_1099 | Other Identifier | Abbott |
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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.
This is a prospective, non-randomized, multicenter, pre-National Medical Products Administration (NMPA) approval study to confirm the safety and effectiveness of the Advisorâ„¢ HD Grid X Mapping Catheter, Sensor Enabledâ„¢ when used with EnSiteâ„¢ X EP System v3.1.1 to create accurate geometries and voltage maps in the atria.
A total of up to 200 subjects who have paroxysmal atrial fibrillation will be enrolled in this clinical study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Grid X and EnSite X v3.1.1 Software | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Grid X and EnSite X v3.1.1 Software | Device | The 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| From the study procedure to subject's discharge from the hospital |
| 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:
| During the study procedure |
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Inclusion Criteria:
Subject must provide written informed consent prior to any clinical investigation-related procedure.
Subject is at least 18 years of age.
Documented symptomatic paroxysmal AF, defined as:
Subject plans to undergo a cardiac electroanatomic mapping and ablation procedure to treat their paroxysmal AF.
Able and willing to comply with all trial requirements including pre-procedure, post-procedure, and follow-up testing and requirements
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rio Zhan | Contact | +86-21-2320 4181 | wanlei.zhan@abbott.com |
| Name | Affiliation | Role |
|---|---|---|
| Amber Miller | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qilu Hospital of Shandong University | Recruiting | Jinan | Shandong | China |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| West China Hospital of Sichuan University | Recruiting | Chengdu | Sichuan | China |
|
| Sir Run Run Shaw Hospital Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | China |
|
| The First Affiliated Hospital of Ningbo University | Recruiting | Ningbo | Zhejiang | China |
|
| Beijing Anzhen Hospital, Capital Medical University | Recruiting | Beijing | China |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |