Atrial Fibrillation Clinical Trials

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Grid eXplore Mapping Study

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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:

‣ 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.

• 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

Locations
Other Locations
China
Beijing Anzhen Hospital, Capital Medical University
NOT_YET_RECRUITING
Beijing
West China Hospital of Sichuan University
NOT_YET_RECRUITING
Chengdu
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
RECRUITING
Hangzhou
Qilu Hospital of Shandong University
RECRUITING
Jinan
The First Affiliated Hospital of Ningbo University
RECRUITING
Ningbo
Contact Information
Primary
Rio Zhan
wanlei.zhan@abbott.com
+86-21-2320 4181
Time Frame
Start Date: 2026-04-02
Estimated Completion Date: 2027-10-31
Participants
Target number of participants: 200
Treatments
Experimental: Grid X and EnSite X v3.1.1 Software
Related Therapeutic Areas
Sponsors
Leads: Abbott Medical Devices

This content was sourced from clinicaltrials.gov